Periodontal Diseases
Conditions
Keywords
Flap debridement, Flap osseous, Tooth extractions, Guided Tissue Regeneration, IV sedation, Local anesthesia
Brief summary
Immediate post-suturing administration of either one of two dental anesthetic solutions or a placebo prior to dismissal.
Detailed description
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.
Interventions
DRUGXylocaine 2 % with 1:100,000 epinephrine
Local anesthetic used during dental procedures
DRUGBupivicaine 0.5% with 1:200,000 epinephrine
Local anesthetic used during dental procedures
OTHERPlacebo
0.9% Normal Saline solution used in place of local anesthetic
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Intervention model description
A randomized, placebo-controlled, parallel design study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
-Patients who have undergone a comprehensive periodontal evaluation and treatment plan not related to participation in this study and… 1. require flap surgery of 2 to 5 teeth in a continuous site (including flap debridement, flap osseous, extractions, and Guided Tissue Regeneration (GTR) procedures), and… 2. require IV sedation and local anesthesia or local anesthesia only… 3. in either the maxillary or mandibular arch.
Exclusion criteria
1. Pregnancy, or those planning to become pregnant 2. allergy or any medical issue using Lidocaine or Bupivacaine 3. inability to take non-steroidal anti-inflammatory drugs (NSAIDS) or acetaminophen 4. non-English speaking 5. not possessing an I-phone or Android device 6. patients requiring narcotic for IV sedation 7. patients requiring either IV or oral steroids during the perioperative period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain using Visual Analog Scale (VAS) | Baseline to 48 hours | 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. |
| Number of Ibuprofen administered | Baseline to 48 hours | Additive number of ibuprofen taken over monitoring period |
| Number of Tylenol administered | Baseline to 48 hours | Additive number of acetaminophen taken over monitoring period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gender of patient | Baseline to 48 hours | Difference in pain response based upon gender of participant |
| Arch Response | Baseline to 48 hours | Difference in pain response based upon arch |
| Age of patient | Baseline to 48 hours | Difference in pain response based upon age of participant |
| Number of teeth | Baseline to 48 hours | Difference in pain response based upon number of teeth per surgical site |
| Type of procedure | Baseline to 48 hours | Difference in pain response based upon type of procedure |
Countries
United States
Outcome results
None listed