Lidocaine + Clonidine for Intraoral Anesthesia in Patient... | NCT02371759 | Trialant
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Studies Lidocaine + Clonidine for Intraoral Anesthesia in Patients With Diabetes Mellitus Type 2 NCT02371759 Show options Diabetes Mellitus Local Anesthesia L+C maxillary anesthesia L+C mandibular anesthesia L+E maxillary anesthesia L+E mandibular anesthesia Obsolete or Duplicate NCT IDs Not provided
ID Type Description Link 175021 Other Grant/Funding Number Ministry of Education, Science and Technological Development
Lidocaine + Clonidine for Intraoral Anesthesia in Patients With Diabetes Mellitus Type 2
Efficacy and Safety of Intraoral Local Anesthesia by Lidocaine + Clonidine in Patients With Diabetes Mellitus Type 2
University of Belgrade OTHER
Overall Recruitment Status or Expanded Access Status Completed
First Submission Date that Met QC Criteria Feb 19, 2015
Results First Submitted Date Dec 26, 2016
Results First Submitted that Met QC Criteria Mar 22, 2017
Results First Posted Date May 3, 2017 Actual
Certification/Extension (aka Delayed Results) First Submitted Date Not provided
Certification/Extension First Submitted that Passed QC Review Not provided
Certification/Extension First Posted Date Not provided
Last Update Submitted Date Mar 22, 2017
Responsible Party, by Official Title Bozidar Brkovic, DDS, MSc, PhD, Professor, Professor, DDS, MSc, PhD, University of Belgrade Principal Investigator
University of Belgrade OTHER
Has Data Monitoring Committee (DMC) No
Pediatric Postmarket Surveillance of a Device Product Not provided
The purpose of this study is to determine whether 2% lidocaine (L) + clonidine (C) (15 mcg/ml) as a vasoconstrictor achieves efficient (equal or better parameters of intraoral local anesthesia in comparison to 2% lidocaine + epinephrine (E) (1:80 000)) and safe (stable cardiovascular parameters - systolic, diastolic, mean blood pressure and heart rate) intraoral local anesthesia in patients with Diabetes mellitus type 2.
Patients with diabetes mellitus type 2, represent a risk for performing regional anesthesia techniques due to microvascular (microangiopathy, neuropathy) and macrovascular (hypertension, coronary heart disease) complications. There is evidence that local anesthetic toxicity may be increased in diabetic setting due to underlying neuropathy; while interaction of diabetic blood vessels with vasoconstrictors may be of importance because of microangiopathic changes. Lately, regional anesthesia protocol in general surgery for patients with diabetes mellitus was released, proposing reduction of local anesthetic concentration and avoiding epinephrine as vasoconstrictor.
Oral cavity tissues in diabetes mellitus also suffer from neuropathy (burning, paresthesia, teeth loss, temporomandibular dysfunction, xerostomia) and microangiopathy (periodontal disease, salivary gland dysfunction). Most widely used vasoconstrictor for intraoral local anesthesia, epinephrine, is an alpha- and beta- adrenergic agonist. Because of its beta-adrenergic effects, epinephrine could adversely affect cardiovascular function, especially in risk patients. There are data suggesting that intraoral local anesthesia obtained with 2% lidocaine with clonidine, selective alpha 2-adrenoceptor agonist as a vasoconstrictor, is characterized with significantly more stable cardiovascular parameters and similar parameters of local anesthesia with respect to lidocaine with epinephrine in healthy and hypertensive patients.
With regard to aforementioned, the aim of this randomized double-blind controlled clinical trial is to evaluate and compare efficacy and safety of intraoral local anesthesia obtained with 2% lidocaine (L) + clonidine (15 mcg/ml) (C) or 2% L + epinephrine (1:80 000) (E), comparing healthy and diabetes mellitus type 2 patients. Prior to tooth extraction, random allocation to one of four groups (L+C maxillary infiltration, L+C mandibular block, L+E maxillary infiltration and L+E mandibular block) is performed for diabetic (30 per group) and healthy (30 per group) patients. Parameters of local anesthesia (onset, duration, intensity, width of anesthetic field for maxillary infiltration), cardiovascular parameters (systolic, diastolic, mean arterial pressure; heart rate and electrocardiographic changes), quality of postoperative analgesia (assessed by Visual Analogue Scale, Numerical Rating Scale and number of consumed analgesics) and postoperative complications (infection, bleeding, paresthesia, delayed wound healing) are evaluated and compared.
Diabetes Mellitus Local Anesthesia Number of References to an Expanded Access Study Not provided
Target Follow-Up Duration Not provided
No data available
No data is available for this block.
Label Type Description Intervention Names Diabetics: L+C maxillary anesthesia Experimental Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
Drug: L+C maxillary anesthesia Diabetics: L+C mandibular anesthesia Experimental Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
Drug: L+C mandibular anesthesia Diabetics: L+E maxillary anesthesia Active Comparator Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
Drug: L+E maxillary anesthesia Diabetics: L+E mandibular anesthesia Active Comparator Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
Drug: L+E mandibular anesthesia Healthy: L+C maxillary anesthesia Experimental Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
Name Type Description Arm Group Labels Other Names L+C maxillary anesthesia Drug Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+C maxillary anesthesia Healthy: L+C maxillary anesthesia
Measure Description Time Frame Duration of Intraoral Local Anesthesia Time until cessation in soft tissue numbness
Up to 6 hours after local anesthesia injection Intensity of Intraoral Local Anesthesia Number of participants who reported values > 0 after pin-prick testing, using Visual Analogue Scale (VAS) and Numerical Rating Scale (NRS). VAS is represented by line 100 mm long, with one end marked with 0 and words "no pain" , while the other end is marked with 100 and words "the worst pain imanginable". VRS scale is represented by line 100 mm long, marked with numbers from 0 to 10, where 0 corresponds to "no pain", and 10 corresponds to "the worst pain imaginable". For both scales, higher scores represent worse outcomes.
Up to 10 minutes after local anesthesia injection Baseline Systolic Blood Pressure Baseline, 0 minutes Systolic Blood Pressure at 10 Minutes Systolic blood pressure values 5 minutes after local anesthesia injection
10th minute Systolic Blood Pressure at 15 Minutes Systolic blood pressure values 10 minutes after local anesthesia injection
15th minute Systolic Blood Pressure at 20 Minutes Systolic blood pressure values 15 minutes after local anesthesia injection
20th minute Systolic Blood Pressure at 35 Minutes Systolic blood pressure values 30 minutes after local anesthesia injection
Measure Description Time Frame Onset of Intraoral Local Anesthesia Evaluated by pin-prick after subjective feeling of soft tissue numbness appeared after local anesthesia injection
Up to 10 minutes, until subjective feeling of soft tissue numbnes Width of Anesthetic Field After Maxillary Infiltration Anesthesia
Inclusion Criteria:
Healthy participants: ASA I
Diabetic type 2 participants: ASA III (HbA1c level < 9%)
Required a single-root teeth indicated for non-complicated extraction
Dental diagnosis of periodontal disease, tooth fracture, chronic periapical lesion and root infection
Subjects give informed written consent
Exclusion Criteria:
Pregnancy and lactation
Allergy to used drugs and food
Hepatic and/or renal failure
ASA IV patients
Tobacco smokers
History of alcoholism and/or drug abuse and addiction
Accepts Healthy Volunteers No
Name Affiliation Role Dragica DM Stojic, DDS, PhD School of Dental Medicine, University of Belgrade Principal Investigator Bozidar M Brkovic, DDS, PhD School of Dental Medicine, University of Belgrade Principal Investigator Marija S Milic, DDS School of Dental Medicine, University of Belgrade Principal Investigator
Facility Status City State ZIP Country Contacts School of Dental Medicine, University of Belgrade Belgrade 11000 Serbia
No data available
No data is available for this block.
No data available
No data is available for this block.
Participants recruited between june 2013 and december 2015 among the patients of Clinic of Oral Surgery, Faculty of Dental Medicine, University of Belgrade
ID Title Description FG000 Diabetics: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
FG001 Diabetics: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
FG002 Diabetics: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
FG003 Diabetics: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
FG004 Healthy: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
FG005 Healthy: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
FG006 Healthy: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
FG007 Healthy: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Title Milestones Reasons Not Completed Overall Study Type Comment Milestone Data STARTED FG000 32 subjects FG001 31 subjects FG002 33 subjects FG003 31 subjects FG004 27 subjects FG005 26 subjects FG006 25 subjects FG007 28 subjects COMPLETED FG000 29 subjects FG001 30 subjects FG002 32 subjects FG003 31 subjects FG004 NOT COMPLETED FG000 3 subjects FG001 1 subjects FG002 1 subjects FG003 0 subjects FG004
Type Comment Reasons Protocol Violation FG000 3 subjects FG001 1 subjects FG002 1 subjects FG003
Baseline Analysis Population Description Not provided
ID Title Description BG000 Diabetics: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
BG001 Diabetics: L+C Mandibular Anesthesia
Title Description Population Description Parameter Type Dispersion Type Unit of Measure Calculate Percentage Denominator Units Selected Denominators Classes Age, Categorical Age between 18 and 65 years
Type Title Description Population Description Reporting Status Anticipated Posting Date Parameter Type Dispersion Type Unit of Measure Calculate Percentage Time Frame Units Analyzed Denominator Units Selected Arm/Group Information Denominators Classes Analyses Primary Duration of Intraoral Local Anesthesia Time until cessation in soft tissue numbness
Posted Mean Standard Deviation minutes Up to 6 hours after local anesthesia injection ID Title Description OG000 Diabetics: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG001 Diabetics: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
All-Cause Mortality Comment Not provided
ID Title Description Deaths (Affected) Deaths (At Risk) Serious Events (Affected) Serious Events (At Risk) Other Events (Affected) Other Events (At Risk) EG000 Diabetics: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Are all PI(s) employees of the sponsor? Yes
Title Organization Phone Extension Email DDS PhD Professor Dragica Stojic, DDS PhD Professor Bozidar Brkovic, DDS PhD Marija Milic University of Belgrade, Faculty of Dental Medicine + 381 11 2685 280 244 brkovic73@yahoo.com
No data available
No data is available for this block.
ID Term D003920 Diabetes Mellitus
ID Term D044882 Glucose Metabolism Disorders D008659 Metabolic Diseases D009750 Nutritional and Metabolic Diseases D004700 Endocrine System Diseases
No data available
No data is available for this block.
Randomized
Intervention Model Description Not provided
Participant Care Provider Investigator Outcomes Assessor
Drug: L+C maxillary anesthesia Healthy: L+C mandibular anesthesia Experimental Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
Drug: L+C mandibular anesthesia
Healthy: L+E maxillary anesthesia Active Comparator Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
Drug: L+E maxillary anesthesia
Healthy: L+E mandibular anesthesia Active Comparator Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
Drug: L+E mandibular anesthesia
L+C mandibular anesthesia Drug Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+C mandibular anesthesia Healthy: L+C mandibular anesthesia
L+E maxillary anesthesia Drug Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Diabetics: L+E maxillary anesthesia Healthy: L+E maxillary anesthesia
L+E mandibular anesthesia Drug Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Diabetics: L+E mandibular anesthesia Healthy: L+E mandibular anesthesia
Baseline Diastolic Blood Pressure baseline, 0 minutes
Diastolic Blood Pressure at 10 Minutes Diastolic blood pressure values 5 minutes after local anesthesia injection
10th minute
Diastolic Blood Pressure at 15 Minutes Diastolic blood pressure values 10 minutes after local anesthesia injection
15th minute
Diastolic Blood Pressure at 20 Minutes Diastolic blood pressure values 15 minutes after local anesthesia injection
20th minute
Diastolic Blood Pressure at 35 Minutes Diastolic blood pressure values 30 minutes after local anesthesia injection
35th minute
Baseline Values of Heart Rate baseline, 0 minutes
Heart Rate at 10 Minutes Heart rate 5 minutes after local anesthesia injection, 10 minutes after baseline measurement
10th minute
Heart Rate at 15 Minutes Heart rate 10 minutes after local anesthesia injection, 15 minutes after baseline measurement
15th minute
Heart Rate at 20 Minutes Heart rate 15 minutes after local anesthesia injection, 20 minutes after baseline measurement
20th minute
Ceart Rate at 35 Minutes Heart rate 30 minutes after local anesthesia injection, 35 minutes after baseline measurement
35th minute
Baseline Electrocardiogram baseline, 0 minutes
Electrocardiogram at 10 Minutes ECG 5 minutes after local anesthesia injection, 10 minutes after baseline measurement
10th minute
Electrocardiogram at 15 Minutes ECG 10 minutes after local anesthesia injection, 15 minutes after baseline measurement
15th minute
Electrocardiogram at 20 Minutes ECG 15 minutes after local anesthesia injection, 20 minutes after baseline measurement
20th minute
Soft tissue numbness area determined by pin-prick test after maxillary infiltration anesthesia. Not tested for mandibular ablock anesthesia.
Up to 10 minutes after injection of local anesthesia
Postoperative Analgesia Number of participants who experienced postoperative pain, VAS, NRS
up to 24 hours after tooth extraction
Local Postoperative Complications Postoperative paresthesia by clinical examination
24 hours, 7 days
24 subjects
FG005 25 subjects
FG006 25 subjects
FG007 24 subjects 3 subjects
FG005 1 subjects
FG006 0 subjects
FG007 4 subjects 0 subjects
FG004 3 subjects
FG005 1 subjects
FG006 0 subjects
FG007 3 subjects Withdrawal by Subject FG000 0 subjects FG001 0 subjects FG002 0 subjects FG003 0 subjects FG004 0 subjects FG005 0 subjects FG006 0 subjects FG007 1 subjects
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
BG002 Diabetics: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
BG003 Diabetics: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
BG004 Healthy: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
BG005 Healthy: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
BG006 Healthy: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
BG007 Healthy: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
BG008 Total Total of all reporting groups
29
BG001 30
BG002 32
BG003 31
BG004 24
BG005 25
BG006 25
BG007 24
BG008 220 Title Denominators Categories Title Measurements <=18 years BG000 0 BG001 0 BG002 0 BG003 0 BG004 0 BG005 0 BG006 0 BG007 0 BG008 0 Between 18 and 65 years BG000 29 BG001 30 BG002 32 BG003 31 BG004 >=65 years BG000 0 BG001 0 BG002 0 BG003 0 BG004
Sex: Female, Male Count of Participants Participants Title Denominators Categories Title Measurements Female BG000 22 BG001 16 BG002 21 BG003 14 BG004 9 BG005 15 BG006 15 BG007 14 BG008 126 Male BG000 7 BG001 14 BG002 11 BG003 17 BG004
Region of Enrollment Number participants Title Denominators Categories Serbia Title Measurements BG000 32 BG001 31 BG002 33 BG003 31 BG004 24 BG005 25 BG006 25 BG007 24 BG008 220
Body Mass Mean Standard Deviation kilograms Title Denominators Categories Title Measurements BG000 78.72 ± 11.19 BG001 75.03 ± 11.53 BG002 85.84 ± 14.76 BG003 79.45 ± 17.34 BG004 79.50 ± 15.22 BG005 74.59 ± 9.64 BG006 71.01 ± 12.08 BG007 71.59 ± 7.81 BG008 76.90 ± 8.42
Fasting Plasma Glucose Available only for diabetic participants
Mean Standard Deviation milimoles per liter Title Denominators Categories Title Measurements BG000 8.12 ± 3.01 BG001 7.55 ± 2.53 BG002 9.66 ± 4.02 BG003 8.35 ± 2.49 BG004 NA ± NA Available only for diabetic participants BG005 NA ± NA Available only for diabetic participants BG006 NA ± NA Available only for diabetic participants BG007 NA ± NA Available only for diabetic participants BG008 NA ± NA Available only for diabetic participants
Duration of Diabetes Mean Standard Deviation years Title Denominators Categories Title Measurements BG000 6.83 ± 4.59 BG001 9.57 ± 5.51 BG002 9.77 ± 7.62 BG003 9.27 ± 6.09 BG004 NA ± NA Available only for diabetic participants BG005 NA ± NA Available only for diabetic participants BG006 NA ± NA Available only for diabetic participants BG007 NA ± NA Available only for diabetic participants BG008 NA ± NA Available only for diabetic participants
Glycosilated Hemoglobin Mean Standard Deviation percents Title Denominators Categories Title Measurements BG000 7.42 ± 1.25 BG001 7.55 ± 2.53 BG002 7.63 ± 1.72 BG003 7.97 ± 1.50 BG004 NA ± NA Available only for diabetic participants BG005 NA ± NA Available only for diabetic participants BG006 NA ± NA Available only for diabetic participants BG007 NA ± NA Available only for diabetic participants BG008 NA ± NA Available only for diabetic participants
Number of participants with modified diet Count of Participants Participants Title Denominators Categories Title Measurements BG000 22 BG001 30 BG002 31 BG003 30 BG004 NA Available only for diabetic participants BG005 NA Available only for diabetic participants BG006 NA Available only for diabetic participants BG007 NA Available only for diabetic participants BG008 NA Total not calculated because data are not available (NA) in one or more arms.
Number of participants on OHA therapy Count of Participants Participants Title Denominators Categories Title Measurements BG000 28 BG001 29 BG002 30 BG003 30 BG004 NA Available only for diabetic participants BG005 NA Available only for diabetic participants BG006 NA Available only for diabetic participants BG007 NA Available only for diabetic participants BG008 NA Total not calculated because data are not available (NA) in one or more arms.
Number of participants on insulin therapy Count of Participants Participants Title Denominators Categories Title Measurements BG000 2 BG001 4 BG002 8 BG003 4 BG004 NA Available only for diabetic participants BG005 NA Available only for diabetic participants BG006 NA Available only for diabetic participants BG007 NA Available only for diabetic participants BG008 NA Total not calculated because data are not available (NA) in one or more arms.
Hypertension Count of Participants Participants Title Denominators Categories Title Measurements BG000 16 BG001 26 BG002 19 BG003 17 BG004 NA Available only for diabetic participants BG005 NA Available only for diabetic participants BG006 NA Available only for diabetic participants BG007 NA Available only for diabetic participants BG008 NA Total not calculated because data are not available (NA) in one or more arms.
Coronary Artery Disease Count of Participants Participants Title Denominators Categories Title Measurements BG000 12 BG001 14 BG002 14 BG003 13 BG004 NA Available only for diabetic participants BG005 NA Available only for diabetic participants BG006 NA Available only for diabetic participants BG007 NA Available only for diabetic participants BG008 NA Total not calculated because data are not available (NA) in one or more arms.
Peripheral Neuropathy Count of Participants Participants Title Denominators Categories Title Measurements BG000 9 BG001 12 BG002 12 BG003 10 BG004 NA Available only for diabetic participants BG005 NA Available only for diabetic participants BG006 NA Available only for diabetic participants BG007 NA Available only for diabetic participants BG008 NA Total not calculated because data are not available (NA) in one or more arms.
Intraoral Neuropathy Count of Participants Participants Title Denominators Categories Title Measurements BG000 14 BG001 16 BG002 17 BG003 18 BG004 NA Available only for diabetic participants BG005 NA Available only for diabetic participants BG006 NA Available only for diabetic participants BG007 NA Available only for diabetic participants BG008 NA Total not calculated because data are not available (NA) in one or more arms.
OG002 Diabetics: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG003 Diabetics: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG004 Healthy: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG005 Healthy: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG006 Healthy: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG007 Healthy: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Units Counts Participants OG000 29 OG001 30 OG002 32 OG003 31 OG004 24 OG005 25 OG006 25 OG007 24
Title Denominators Categories Title Measurements OG000 132.48 ± 91.86 OG001 173.27 ± 70.44 OG002 182.09 ± 57.86 OG003 195.35 ± 68.99 OG004 108.82 ± 27.76 OG005 155.59 ± 60.75 OG006 114.74 ± 39.72 OG007 172.91 ± 68.93
Group IDs Group Description Statistical Method Statistical Comment P-Value P-Value Comment Parameter Type Parameter Value Dispersion Type Dispersion Value Confidence Interval Sides Confidence Interval % CI Lower Limit CI Upper Limit CI Lower Limit Comment CI Upper Limit Comment Estimate Comment Tested Non-Inferiority Non-Inferiority Type Non-Inferiority Comment Other Analysis Description OG000 OG001 OG002 OG003 OG004 OG005 OG006 OG007 In order to detect 20% difference in intraoral anesthesia duration between healthy and diabetic participants, with 80 % statistical power at a two-tailed significance level of 0.05 using Mann Whitney U test, it was calculated that at least 24 participants must be included in each group
Wilcoxon (Mann-Whitney) <0.05 Non-Inferiority or Equivalence In order to detect 20% difference in intraoral anesthesia duration between healthy and diabetic participants, with 80 % statistical power at a two-tailed significance level of 0.05 using Mann Whitney U test, it was calculated that at least 24 participants must be included in each group
Primary Intensity of Intraoral Local Anesthesia Number of participants who reported values > 0 after pin-prick testing, using Visual Analogue Scale (VAS) and Numerical Rating Scale (NRS). VAS is represented by line 100 mm long, with one end marked with 0 and words "no pain" , while the other end is marked with 100 and words "the worst pain imanginable". VRS scale is represented by line 100 mm long, marked with numbers from 0 to 10, where 0 corresponds to "no pain", and 10 corresponds to "the worst pain imaginable". For both scales, higher scores represent worse outcomes.
Posted Count of Participants Participants Up to 10 minutes after local anesthesia injection ID Title Description OG000 Diabetics: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG001 Diabetics: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG002 Diabetics: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG003 Diabetics: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG004 Healthy: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG005 Healthy: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG006 Healthy: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG007 Healthy: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Units Counts Participants OG000 29 OG001 30 OG002 32 OG003
Title Denominators Categories
Group IDs Group Description Statistical Method Statistical Comment P-Value P-Value Comment Parameter Type Parameter Value Dispersion Type Dispersion Value Confidence Interval Sides Confidence Interval % CI Lower Limit CI Upper Limit CI Lower Limit Comment CI Upper Limit Comment Estimate Comment Tested Non-Inferiority Non-Inferiority Type Non-Inferiority Comment Other Analysis Description OG000 OG001 OG002 OG003 OG004 OG005 OG006 OG007 Chi-squared <0.05 Superiority or Other
Primary Baseline Systolic Blood Pressure Posted Mean Standard Deviation milimeters of Hg Baseline, 0 minutes ID Title Description OG000 Diabetics: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG001 Diabetics: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG002 Diabetics: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG003 Diabetics: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG004 Healthy: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG005 Healthy: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG006 Healthy: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG007 Healthy: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Units Counts Participants OG000 29 OG001 30 OG002 32 OG003
Title Denominators Categories Title Measurements OG000 135.2759 ± 16.69665611 OG001 137.7333 ± 18.43335308 OG002 134.8125 ± 18.66934265 OG003
Primary Systolic Blood Pressure at 10 Minutes Systolic blood pressure values 5 minutes after local anesthesia injection
Posted Mean Standard Deviation milimeters of Hg 10th minute ID Title Description OG000 Diabetics: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG001 Diabetics: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG002 Diabetics: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG003 Diabetics: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG004 Healthy: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG005 Healthy: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG006 Healthy: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG007 Healthy: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Units Counts Participants OG000 29 OG001 30 OG002 32 OG003
Title Denominators Categories Title Measurements OG000 130.3793 ± 18.81377496 OG001 136.8333 ± 14.27098173 OG002 137.4375 ± 19.73033934 OG003
Primary Systolic Blood Pressure at 15 Minutes Systolic blood pressure values 10 minutes after local anesthesia injection
Posted Mean Standard Deviation milimeters of Hg 15th minute ID Title Description OG000 Diabetics: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG001 Diabetics: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG002 Diabetics: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG003 Diabetics: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG004 Healthy: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG005 Healthy: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG006 Healthy: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG007 Healthy: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Units Counts Participants OG000 29 OG001 30 OG002 32 OG003
Title Denominators Categories Title Measurements OG000 133.5862 ± 13.51590925 OG001 133.4667 ± 14.12684735 OG002 137.4688 ± 19.28058421 OG003
Primary Systolic Blood Pressure at 20 Minutes Systolic blood pressure values 15 minutes after local anesthesia injection
Posted Mean Standard Deviation milimeters of Hg 20th minute ID Title Description OG000 Diabetics: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG001 Diabetics: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG002 Diabetics: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG003 Diabetics: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG004 Healthy: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG005 Healthy: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG006 Healthy: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG007 Healthy: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Units Counts Participants OG000 29 OG001 30 OG002 32 OG003
Title Denominators Categories Title Measurements OG000 130.2414 ± 14.98011819 OG001 131.3333 ± 14.73755076 OG002 132.4063 ± 17.69428443 OG003
Primary Systolic Blood Pressure at 35 Minutes Systolic blood pressure values 30 minutes after local anesthesia injection
Posted Mean Standard Deviation milimeters of Hg 35th minute ID Title Description OG000 Diabetics: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG001 Diabetics: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG002 Diabetics: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG003 Diabetics: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG004 Healthy: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG005 Healthy: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG006 Healthy: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG007 Healthy: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Units Counts Participants OG000 29 OG001 30 OG002 32 OG003
Title Denominators Categories Title Measurements OG000 127.2759 ± 12.91979807 OG001 130.3 ± 13.12841089 OG002 132.5625 ± 17.0330561 OG003
Primary Baseline Diastolic Blood Pressure Posted Mean Standard Deviation milimeters of Hg baseline, 0 minutes ID Title Description OG000 Diabetics: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG001 Diabetics: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG002 Diabetics: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG003 Diabetics: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG004 Healthy: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG005 Healthy: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG006 Healthy: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG007 Healthy: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Units Counts Participants OG000 29 OG001 30 OG002 32 OG003
Title Denominators Categories Title Measurements OG000 74.1379 ± 11.37894088 OG001 81.7667 ± 9.722648048 OG002 75.25 ± 12.09372004 OG003
Primary Diastolic Blood Pressure at 10 Minutes Diastolic blood pressure values 5 minutes after local anesthesia injection
Posted Mean Standard Deviation milimeters of Hg 10th minute ID Title Description OG000 Diabetics: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG001 Diabetics: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG002 Diabetics: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG003 Diabetics: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG004 Healthy: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG005 Healthy: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG006 Healthy: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG007 Healthy: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Units Counts Participants OG000 29 OG001 30 OG002 32 OG003
Title Denominators Categories Title Measurements OG000 74.0345 ± 8.398480979 OG001 75.3667 ± 12.09830424 OG002 75.6875 ± 14.74829132 OG003
Primary Diastolic Blood Pressure at 15 Minutes Diastolic blood pressure values 10 minutes after local anesthesia injection
Posted Mean Standard Deviation milimeters of Hg 15th minute ID Title Description OG000 Diabetics: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG001 Diabetics: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG002 Diabetics: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG003 Diabetics: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG004 Healthy: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG005 Healthy: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG006 Healthy: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG007 Healthy: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Units Counts Participants OG000 29 OG001 30 OG002 32 OG003
Title Denominators Categories Title Measurements OG000 72.6897 ± 6.876998142 OG001 74.8 ± 9.672154605 OG002 74.8125 ± 13.17729597 OG003
Primary Diastolic Blood Pressure at 20 Minutes Diastolic blood pressure values 15 minutes after local anesthesia injection
Posted Mean Standard Deviation milimeters of Hg 20th minute ID Title Description OG000 Diabetics: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG001 Diabetics: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG002 Diabetics: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG003 Diabetics: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG004 Healthy: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG005 Healthy: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG006 Healthy: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG007 Healthy: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Units Counts Participants OG000 29 OG001 30 OG002 32 OG003
Title Denominators Categories Title Measurements OG000 71.6897 ± 7.865400945 OG001 74.1667 ± 9.013718791 OG002 74.1563 ± 11.65390527 OG003
Primary Diastolic Blood Pressure at 35 Minutes Diastolic blood pressure values 30 minutes after local anesthesia injection
Posted Mean Standard Deviation milimeters of Hg 35th minute ID Title Description OG000 Diabetics: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG001 Diabetics: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG002 Diabetics: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG003 Diabetics: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG004 Healthy: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG005 Healthy: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG006 Healthy: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG007 Healthy: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Units Counts Participants OG000 29 OG001 30 OG002 32 OG003
Title Denominators Categories Title Measurements OG000 70.1379 ± 8.140393716 OG001 74.3667 ± 10.37021597 OG002 73.2813 ± 12.59091935 OG003
Primary Baseline Values of Heart Rate Posted Mean Standard Deviation beats per minute baseline, 0 minutes ID Title Description OG000 Diabetics: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG001 Diabetics: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG002 Diabetics: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG003 Diabetics: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG004 Healthy: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG005 Healthy: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG006 Healthy: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG007 Healthy: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Units Counts Participants OG000 29 OG001 30 OG002 32 OG003
Title Denominators Categories Title Measurements OG000 75.0345 ± 10.80172856 OG001 80.7727 ± 6.682366571 OG002 78.3438 ± 10.20312847 OG003
Primary Heart Rate at 10 Minutes Heart rate 5 minutes after local anesthesia injection, 10 minutes after baseline measurement
Posted Mean Standard Deviation beats per minute 10th minute ID Title Description OG000 Diabetics: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG001 Diabetics: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG002 Diabetics: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG003 Diabetics: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG004 Healthy: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG005 Healthy: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG006 Healthy: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG007 Healthy: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Units Counts Participants OG000 29 OG001 30 OG002 32 OG003
Title Denominators Categories Title Measurements OG000 75.3448 ± 11.45262248 OG001 81.7727 ± 5.72311305 OG002 83.3125 ± 10.35012077 OG003
Primary Heart Rate at 15 Minutes Heart rate 10 minutes after local anesthesia injection, 15 minutes after baseline measurement
Posted Mean Standard Deviation beats per minute 15th minute ID Title Description OG000 Diabetics: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG001 Diabetics: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG002 Diabetics: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG003 Diabetics: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG004 Healthy: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG005 Healthy: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG006 Healthy: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG007 Healthy: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Units Counts Participants OG000 29 OG001 30 OG002 32 OG003
Title Denominators Categories Title Measurements OG000 73.0345 ± 10.10828076 OG001 77.4545 ± 6.790883003 OG002 83.4688 ± 10.92196477 OG003
Primary Heart Rate at 20 Minutes Heart rate 15 minutes after local anesthesia injection, 20 minutes after baseline measurement
Posted Mean Standard Deviation beats per minute 20th minute ID Title Description OG000 Diabetics: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG001 Diabetics: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG002 Diabetics: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG003 Diabetics: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG004 Healthy: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG005 Healthy: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG006 Healthy: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG007 Healthy: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Units Counts Participants OG000 29 OG001 30 OG002 32 OG003
Title Denominators Categories Title Measurements OG000 72.2414 ± 9.697772839 OG001 80.2273 ± 7.276477612 OG002 81.3125 ± 11.56032565 OG003
Primary Ceart Rate at 35 Minutes Heart rate 30 minutes after local anesthesia injection, 35 minutes after baseline measurement
Posted Mean Standard Deviation beats per minute 35th minute ID Title Description OG000 Diabetics: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG001 Diabetics: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG002 Diabetics: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG003 Diabetics: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG004 Healthy: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG005 Healthy: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG006 Healthy: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG007 Healthy: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Units Counts Participants OG000 29 OG001 30 OG002 32 OG003
Title Denominators Categories Title Measurements OG000 72.1034 ± 9.236359934 OG001 80.8182 ± 6.095127129 OG002 80.0938 ± 11.04348991 OG003
Primary Baseline Electrocardiogram Posted Count of Participants Participants baseline, 0 minutes ID Title Description OG000 Diabetics: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG001 Diabetics: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG002 Diabetics: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG003 Diabetics: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG004 Healthy: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG005 Healthy: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG006 Healthy: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG007 Healthy: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Units Counts Participants OG000 29 OG001 30 OG002 32 OG003
Title Denominators Categories
Group IDs Group Description Statistical Method Statistical Comment P-Value P-Value Comment Parameter Type Parameter Value Dispersion Type Dispersion Value Confidence Interval Sides Confidence Interval % CI Lower Limit CI Upper Limit CI Lower Limit Comment CI Upper Limit Comment Estimate Comment Tested Non-Inferiority Non-Inferiority Type Non-Inferiority Comment Other Analysis Description OG000 OG001 OG002 OG003 OG004 OG005 OG006 OG007 Chi-squared <0.05 Superiority or Other
Primary Electrocardiogram at 10 Minutes ECG 5 minutes after local anesthesia injection, 10 minutes after baseline measurement
Posted Count of Participants Participants 10th minute ID Title Description OG000 Diabetics: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG001 Diabetics: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG002 Diabetics: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG003 Diabetics: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG004 Healthy: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG005 Healthy: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG006 Healthy: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG007 Healthy: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Units Counts Participants OG000 29 OG001 30 OG002 32 OG003
Title Denominators Categories
Group IDs Group Description Statistical Method Statistical Comment P-Value P-Value Comment Parameter Type Parameter Value Dispersion Type Dispersion Value Confidence Interval Sides Confidence Interval % CI Lower Limit CI Upper Limit CI Lower Limit Comment CI Upper Limit Comment Estimate Comment Tested Non-Inferiority Non-Inferiority Type Non-Inferiority Comment Other Analysis Description OG000 OG001 OG002 OG003 OG004 OG005 OG006 OG007 Chi-squared <0.05 Superiority or Other
Primary Electrocardiogram at 15 Minutes ECG 10 minutes after local anesthesia injection, 15 minutes after baseline measurement
Posted Count of Participants Participants 15th minute ID Title Description OG000 Diabetics: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG001 Diabetics: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG002 Diabetics: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG003 Diabetics: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG004 Healthy: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG005 Healthy: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG006 Healthy: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG007 Healthy: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Units Counts Participants OG000 29 OG001 30 OG002 32 OG003
Title Denominators Categories
Group IDs Group Description Statistical Method Statistical Comment P-Value P-Value Comment Parameter Type Parameter Value Dispersion Type Dispersion Value Confidence Interval Sides Confidence Interval % CI Lower Limit CI Upper Limit CI Lower Limit Comment CI Upper Limit Comment Estimate Comment Tested Non-Inferiority Non-Inferiority Type Non-Inferiority Comment Other Analysis Description OG000 OG001 OG002 OG003 OG004 OG005 OG006 OG007 Chi-squared <0.05 Superiority or Other
Primary Electrocardiogram at 20 Minutes ECG 15 minutes after local anesthesia injection, 20 minutes after baseline measurement
Posted Count of Participants Participants 20th minute ID Title Description OG000 Diabetics: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG001 Diabetics: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG002 Diabetics: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG003 Diabetics: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG004 Healthy: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG005 Healthy: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG006 Healthy: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG007 Healthy: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Units Counts Participants OG000 29 OG001 30 OG002 32 OG003
Title Denominators Categories
Group IDs Group Description Statistical Method Statistical Comment P-Value P-Value Comment Parameter Type Parameter Value Dispersion Type Dispersion Value Confidence Interval Sides Confidence Interval % CI Lower Limit CI Upper Limit CI Lower Limit Comment CI Upper Limit Comment Estimate Comment Tested Non-Inferiority Non-Inferiority Type Non-Inferiority Comment Other Analysis Description OG000 OG001 OG002 OG003 OG004 OG005 OG006 OG007 Chi-squared <0.05 Superiority or Other
Secondary Onset of Intraoral Local Anesthesia Evaluated by pin-prick after subjective feeling of soft tissue numbness appeared after local anesthesia injection
Posted Mean Standard Deviation minutes Up to 10 minutes, until subjective feeling of soft tissue numbnes ID Title Description OG000 Diabetics: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG001 Diabetics: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG002 Diabetics: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG003 Diabetics: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG004 Healthy: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG005 Healthy: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG006 Healthy: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG007 Healthy: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Units Counts Participants OG000 29 OG001 30 OG002 32 OG003
Title Denominators Categories Title Measurements OG000 1.76 ± 0.87 OG001 5.27 ± 2.12 OG002 2.16 ± 1.08 OG003
Group IDs Group Description Statistical Method Statistical Comment P-Value P-Value Comment Parameter Type Parameter Value Dispersion Type Dispersion Value Confidence Interval Sides Confidence Interval % CI Lower Limit CI Upper Limit CI Lower Limit Comment CI Upper Limit Comment Estimate Comment Tested Non-Inferiority Non-Inferiority Type Non-Inferiority Comment Other Analysis Description OG000 OG001 OG002 OG003 OG004 OG005 OG006 OG007 Wilcoxon (Mann-Whitney) <0.05 Superiority or Other
Secondary Width of Anesthetic Field After Maxillary Infiltration Anesthesia Soft tissue numbness area determined by pin-prick test after maxillary infiltration anesthesia. Not tested for mandibular ablock anesthesia.
Posted Mean Standard Deviation milimeters Up to 10 minutes after injection of local anesthesia ID Title Description OG000 Diabetics: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG001 Diabetics: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG002 Diabetics: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG003 Diabetics: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG004 Healthy: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG005 Healthy: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG006 Healthy: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG007 Healthy: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Units Counts Participants OG000 29 OG001 30 OG002 32 OG003
Title Denominators Categories Title Measurements OG000 27.07 ± 1.06 OG001 NA ± NA Measured only after infiltration technique OG002 35.19 ± 1.67
Group IDs Group Description Statistical Method Statistical Comment P-Value P-Value Comment Parameter Type Parameter Value Dispersion Type Dispersion Value Confidence Interval Sides Confidence Interval % CI Lower Limit CI Upper Limit CI Lower Limit Comment CI Upper Limit Comment Estimate Comment Tested Non-Inferiority Non-Inferiority Type Non-Inferiority Comment Other Analysis Description Wilcoxon (Mann-Whitney) <0.05 Superiority or Other
Secondary Postoperative Analgesia Number of participants who experienced postoperative pain, VAS, NRS
Posted Count of Participants Participants up to 24 hours after tooth extraction ID Title Description OG000 Diabetics: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG001 Diabetics: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG002 Diabetics: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG003 Diabetics: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG004 Healthy: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG005 Healthy: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG006 Healthy: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG007 Healthy: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Units Counts Participants OG000 29 OG001 30 OG002 32 OG003
Title Denominators Categories Title Measurements OG000 11 OG001 15 OG002 13 OG003
Group IDs Group Description Statistical Method Statistical Comment P-Value P-Value Comment Parameter Type Parameter Value Dispersion Type Dispersion Value Confidence Interval Sides Confidence Interval % CI Lower Limit CI Upper Limit CI Lower Limit Comment CI Upper Limit Comment Estimate Comment Tested Non-Inferiority Non-Inferiority Type Non-Inferiority Comment Other Analysis Description OG000 OG001 OG002 OG003 OG004 OG005 OG006 OG007 Chi-squared <0.05 Superiority or Other
Secondary Local Postoperative Complications Postoperative paresthesia by clinical examination
Posted Count of Participants Participants 24 hours, 7 days ID Title Description OG000 Diabetics: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG001 Diabetics: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG002 Diabetics: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG003 Diabetics: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG004 Healthy: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG005 Healthy: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
OG006 Healthy: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
OG007 Healthy: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Units Counts Participants OG000 29 OG001 30 OG002 32 OG003
Title Denominators Categories
Group IDs Group Description Statistical Method Statistical Comment P-Value P-Value Comment Parameter Type Parameter Value Dispersion Type Dispersion Value Confidence Interval Sides Confidence Interval % CI Lower Limit CI Upper Limit CI Lower Limit Comment CI Upper Limit Comment Estimate Comment Tested Non-Inferiority Non-Inferiority Type Non-Inferiority Comment Other Analysis Description OG000 OG001 OG002 OG003 OG004 OG005 OG006 OG007 Chi-squared <0.05 Superiority or Other
EG001 Diabetics: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
0 30 0 30
EG002 Diabetics: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
0 32 0 32
EG003 Diabetics: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
0 31 0 31
EG004 Healthy: L+C Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
0 24 0 24
EG005 Healthy: L+C Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
0 25 0 25
EG006 Healthy: L+E Maxillary Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
0 25 0 25
EG007 Healthy: L+E Mandibular Anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
0 24 0 24
Results Disclosure Restriction on PI(s)? Not provided
24
BG005 25
BG006 25
BG007 24
BG008 220 0
BG005 0
BG006 0
BG007 0
BG008 0 15
BG005 10
BG006 10
BG007 10
BG008 94 31
OG004 24
OG005 25
OG006 25
OG007 24 8
OG004 2
OG005 1
OG006 4
OG007 6 31
OG004 24
OG005 25
OG006 25
OG007 24 134.4667
± 17.69119729
OG004 124.0455 ± 11.07325079
OG005 128.1818 ± 15.49388931
OG006 125 ± 11.11918898
OG007 126.5909 ± 18.82322642 31
OG004 24
OG005 25
OG006 25
OG007 24 132.6
± 20.45858857
OG004 120.8182 ± 13.58092627
OG005 122.5909 ± 14.59503859
OG006 125.8261 ± 13.75979708
OG007 125,4091 ± 12.71541656 31
OG004 24
OG005 25
OG006 25
OG007 24 132.0667
± 17.89580957
OG004 114.4545 ± 11.89128241
OG005 116.9091 ± 12.78730431
OG006 123.8696 ± 13.61250878
OG007 127.1818 ± 18.58733917 31
OG004 24
OG005 25
OG006 25
OG007 24 133.2333
± 18.46560212
OG004 108.8182 ± 9.529630256
OG005 120.8636 ± 12.995587
OG006 123.8696 ± 12.15918788
OG007 124.6818 ± 19.56767588 31
OG004 24
OG005 25
OG006 25
OG007 24 132.7
± 16.38723706
OG004 116.3636 ± 7.364945637
OG005 120.1364 ± 14.54809906
OG006 120.6522 ± 10.01185069
OG007 126.4545 ± 17.25916533 31
OG004 24
OG005 25
OG006 25
OG007 24 79.2
± 15.61345574
OG004 73.1364 ± 9.627814144
OG005 80.9545 ± 11.23547644
OG006 76.3913 ± 5.694807287
OG007 75.0909 ± 12.72758194 31
OG004 24
OG005 25
OG006 25
OG007 24 79.1
± 15.23497999
OG004 69.7273 ± 10.49798991
OG005 75.0909 ± 6.560408603
OG006 75.8261 ± 7.010720193
OG007 73.8636 ± 10.14793178 31
OG004 24
OG005 25
OG006 25
OG007 24 80.0333
± 13.86217876
OG004 69.3636 ± 9.800609576
OG005 72.5 ± 7.163066648
OG006 79 ± 15.45374329
OG007 74.1818 ± 11.57434093 31
OG004 24
OG005 25
OG006 25
OG007 24 80.8333
± 13.56465997
OG004 69.4545 ± 6.200823853
OG005 75.9545 ± 8.566141948
OG006 77 ± 9.060403362
OG007 76.0455 ± 14.81144111 31
OG004 24
OG005 25
OG006 25
OG007 24 75.9
± 12.29859279
OG004 69.1364 ± 7.146730552
OG005 77.0455 ± 7.587441207
OG006 77.6087 ± 7.19051857
OG007 74.7273 ± 8.446931357 31
OG004 24
OG005 25
OG006 25
OG007 24 84.2581
± 13.16806172
OG004 76.4545 ± 14.44769638
OG005 73.0333 ± 8.695547948
OG006 76.2174 ± 14.04031463
OG007 76.3636 ± 9.756782523 31
OG004 24
OG005 25
OG006 25
OG007 24 88.5806
± 12.72209153
OG004 74.0455 ± 15.06012481
OG005 73.0667 ± 7.671417688
OG006 83.913 ± 14.36811358
OG007 83.6818 ± 13.23554508 31
OG004 24
OG005 25
OG006 25
OG007 24 86.8387
± 12.41261932
OG004 74.5 ± 12.91271061
OG005 73.4333 ± 4.896327805
OG006 81.6957 ± 14.48974013
OG007 83.5909 ± 11.09121957 31
OG004 24
OG005 25
OG006 25
OG007 24 86.1935
± 12.04552297
OG004 73.6818 ± 12.32645766
OG005 71.8667 ± 5.281881142
OG006 79.8435 ± 13.46448997
OG007 82 ± 11.84824681 31
OG004 24
OG005 25
OG006 25
OG007 24 85.3871
± 11.87062879
OG004 71.3636 ± 12.53393662
OG005 73.4333 ± 7.762157062
OG006 77 ± 13.78017709
OG007 78.2273 ± 12.75382974 31
OG004 24
OG005 25
OG006 25
OG007 24 0
OG004 0
OG005 0
OG006 0
OG007 0 31
OG004 24
OG005 25
OG006 25
OG007 24 0
OG004 0
OG005 0
OG006 0
OG007 0 31
OG004 24
OG005 25
OG006 25
OG007 24 0
OG004 0
OG005 0
OG006 0
OG007 0 31
OG004 24
OG005 25
OG006 25
OG007 24 0
OG004 0
OG005 0
OG006 0
OG007 0 31
OG004 24
OG005 25
OG006 25
OG007 25 5.45
± 2.64
OG004 2.77 ± 1.11
OG005 4.59 ± 2.58
OG006 2.83 ± 0.83
OG007 6.36 ± 2.3 31
OG004 24
OG005 25
OG006 25
OG007 24 OG003
NA
± NA
Measured only after infiltration technique
OG004 23.81 ± 1.07
OG005 NA ± NA Measured only after infiltration technique
OG006 24.52 ± 0.95
OG007 NA ± NA Measured only after infiltration technique 31
OG004 24
OG005 25
OG006 25
OG007 24 14
OG004 5
OG005 14
OG006 10
OG007 12 31
OG004 24
OG005 25
OG006 25
OG007 24 4
OG004 0
OG005 0
OG006 0
OG007 0