Efficacy of Two Injection Techniques on Success Rate of I... | NCT02543619

Studies
Efficacy of Two Injection Techniques on Success Rate of Inferior Alveolar Nerve Anesthesia

NCT02543619

Sponsor

Azad University of Medical Sciences

Status

Completed

Last Update Posted

Sep 7, 2015Estimated

Enrollment

40Actual

Phase

Phase 2

Conditions

Failed Mechanical Induction

Interventions

Injection technique

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

Jun 2015Actual

Completion Date

Aug 2015Actual

First Submitted Date

Sep 4, 2015

First Submission Date that Met QC Criteria

Sep 4, 2015

First Posted Date

Sep 7, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

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

Sep 4, 2015

Last Update Posted Date

Sep 7, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nahid Mohammadzadeh Akhlaghi, Associate Professor, Azad University of Medical SciencesPrincipal Investigator

Lead Sponsor

Azad University of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Forty healthy patients with including criteria who failed to infra alveolar nerve block injection (without lip numbness) have been randomly divided into two groups on a random basis and have received Gow-Gates or another inferior alveolar nerve block injection. Endodontic access cavity preparation has been initiated after complete anesthesia. If patients felt any pain during the steps of caries or dentin removal, Endodontic access cavity preparation or canal working length determination, treatment has been stopped and their pain has been measured by Heft Parker 170 mm Visual Analog Scale (Zero as no pain and 170 as maximum pain ).The data has been analyzed by Mann-U-Whitney and CHI- SQUARE tests.

Detailed Description

The aim of this study was to assess the efficacy of Gow-Gates and inferior alveolar nerve block on success rate of anesthesia in patients with irreversible pulpitis. In this prospective, randomized, double-blind study , forty healthy patients with symptomatic irreversible pulpitis and including criteria who failed to infra alveolar nerve block injection (without lip numbness) have been randomly divided into two groups on a random basis and have received Gow-Gates or another inferior alveolar nerve block injection. Their pain has been evaluated by electric pulp tester every 5 minutes for two times. Endodontic access cavity preparation has been initiated after complete anesthesia. If patients felt any pain during the steps of caries or dentin removal, Endodontic access cavity preparation or canal working length determination, treatment has been stopped and their pain has been measured by Heft Parker 170 mm Visual Analog Scale (Zero as no pain and 170 as maximum pain ). The patients have been instructed to rate any pain during each of the mentioned steps. The data have been analyzed by Mann-U-Whitney and CHI- SQUARE tests.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gow-Gates injection	Active Comparator	An injection technique for infra alveolar nerve anesthesia	Other: Injection technique
Infra alveolar nerve block injection	Active Comparator	An injection technique for infra alveolar nerve anesthesia	Other: Injection technique

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Injection technique	Other	One group received Gow-Gates technique and the other group received Infra Alveolar Nerve Block technique for their failed first one anesthesia	Gow-Gates injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain Score	Heft Parker 170 mm Analog Visual Scale	4 Hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with symptomatic irreversible pulpitis ( Visual Analog Scale ≥ 54) in one mandibular molar who need root canal treatment
without systemic diseases
non smoking
non analgesic/sedative or any medicine consumption
non pregnant
non breast feeding
the patients who received one conventional inferior alveolar nerve block and their block was failed ( without lip numbness)

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nahid Mohammadzadeh Akhlaghi, DDS, MDS	Associate Professor	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dental Branch, AZad UMS		Tehran	Tehran Province		Iran