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Immediate post-suturing administration of either one of two dental anesthetic solutions or a placebo prior to dismissal.
This study seeks to evaluate the pain response following the administration of two anesthetic solutions just prior to patient dismissal from a surgical procedure: 2% Xylocaine with 1:100,000 epi and 0.5% Bupivicaine with 1:200,000 epi in comparison with 0.9% Normal Saline as a placebo. the study team will monitor pain response following these interventions at 4, 8, 12, 24, and 48 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group Xylocaine | Experimental | Participants have been scheduled to receive an area of gum surgery to treat periodontal (gum) disease in their mouth while under intravenous (IV) conscious sedation. The study drug is administered after surgery. |
|
| Treatment group Bupivicaine | Experimental | Participants have been scheduled to receive an area of gum surgery to treat periodontal (gum) disease in their mouth while under intravenous (IV) conscious sedation. The study drug is administered after surgery. |
|
| Placebo control group | Placebo Comparator | Participants have been scheduled to receive an area of gum surgery to treat periodontal (gum) disease in their mouth while under intravenous (IV) conscious sedation. The study drug is administered after surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xylocaine 2 % with 1:100,000 epinephrine | Drug | Local anesthetic used during dental procedures |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain using Visual Analog Scale (VAS) | Pain response recorded using a 20 point visual Analog Scale. The VAS scale is a straight line scale scored from 0-20 with 0 indicating the least amount of pain and 20 the worst pain ever experienced. | Baseline to 48 hours |
| Number of Ibuprofen administered | Additive number of ibuprofen taken over monitoring period | Baseline to 48 hours |
| Number of Tylenol administered | Additive number of acetaminophen taken over monitoring period | Baseline to 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Arch Response | Difference in pain response based upon arch | Baseline to 48 hours |
| Number of teeth | Difference in pain response based upon number of teeth per surgical site |
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Inclusion Criteria:
-Patients who have undergone a comprehensive periodontal evaluation and treatment plan not related to participation in this study and…
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Deas, DDS, MS | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
The PI will share all collected deidentified IPD, all deidentified IPD that underlie results in a publication with colleagues.
Data will be shared at the time of publication in a peer reviewed journal after the study has completed.
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| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D004837 | Epinephrine |
| D002045 | Bupivacaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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A randomized, placebo-controlled, parallel design study.
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Both the surgeon and patient will be blinded as to the intervention provided by covering identifying marks of the anesthetic carpules to be administered. Randomization will be assured by random selection of a slip of paper drawn from a sealed envelope assigning the patient to one of three groups.
| Bupivicaine 0.5% with 1:200,000 epinephrine | Drug | Local anesthetic used during dental procedures |
|
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| Placebo | Other | 0.9% Normal Saline solution used in place of local anesthetic |
|
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| Baseline to 48 hours |
| Type of procedure | Difference in pain response based upon type of procedure | Baseline to 48 hours |
| Gender of patient | Difference in pain response based upon gender of participant | Baseline to 48 hours |
| Age of patient | Difference in pain response based upon age of participant | Baseline to 48 hours |
| Aniline Compounds |
| D000588 | Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |