Clinical Outcomes Maxilla: Buffered 1% Lidocaine vs. Non-buffered 2% Lidocaine

Study Overview
=================
Brief Summary
-----------------
Anecdotal data suggest that the buffered form of the local anesthetic is more potent at equal dosages, and a lower dosage of the buffered drug might be used with an effect equal to higher dosage not buffered. Clinical data are needed to confirm these anecdotal data. No published data exist comparing buffered local anesthetics at lower drug concentrations to current dosages commonly used in dental and oral surgical procedures

Detailed Description
-----------------
Specific Aims: Compare clinical depths of pulpal anesthesia for maxillary molar and canine teeth at 30min intervals post injection after maxillary field block anesthesia with buffered 1% lidocaine with 1/100,000 epinephrine as compared to non-buffered 2% lidocaine with 1/100,000 epinephrine. Hypotheses: No differences exist in anesthetic depth for pulpal anesthesia after intraoral injection for maxillary field block anesthesia between buffered 1% lidocaine with 1/100,000 epinephrine as compared to non-buffered 2% lidocaine with 1/100,000 epinephrine. Study Time Frame: 6 months: Month One Recruit 24 volunteers as subjects, Prepare case-books. Months Two-Three Clinical Study. Months Four-Five Analyze Lab data. Month Six Prepare Abstracts, Papers Methods: Blinded, Randomized Clinical Design, Recruit subjects with Institutional Review Board approved consent at University of North Carolina. Subjects will serve as their own controls in a cross-over AB/BA study design which is uniform within sequences, uniform within periods, and balanced. Randomized subjects to be injected orally for maxillary field block (Posterior alveolar, Anterior alveolar, Palatal sensory nerves) alternatively with 4cc of buffered 1% lidocaine with 1/100,000 epinephrine and 4cc non-buffered of 2% lidocaine with 1/100,000 epinephrine. Assessment: pre, and post-anesthetic administration for pulpal anesthesia with cold, electronic pulp test at maxillary molar and canine at 30 minute intervals.

Official Title
-----------------
Pilot Study: Comparison of Buffered 1% vs. Non-Buffered 2% Lidocaine Used in Dental and Oral Surgical Procedures: Clinical Outcomes Maxilla

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Drug: Lidocaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists Risk Classification I Willingness to participate in two sessions Exclusion Criteria: Allergy to lidocaine class of anesthetic drugs Local anesthetic drug use in past week Current symptoms teeth or oral mucosa

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Buffered 1% lidocaine<br>In week One each subject would receive the anesthetic, 5cc, to block the Posterior alveolar, Anterior alveolar, Palatal nerves.Maxillary molar and canine tested for pulpal anesthesia. At least a week later, injections for the maxillary field block would involve the alternate local anesthetic combination. Maxillary molar and canine tested for pulpal anesthesia. | Drug: Lidocaine<br>* Intraoral maxillary field block<br>* Other names: xylocaine;|
| Active Comparator: Non-Buffered lidocaine<br>In week One each subject would receive the anesthetic, 5cc, to block the Posterior alveolar, Anterior alveolar, Palatal nerves. Maxillary molar and canine tested for pulpal anesthesia. At least a week later, injections for the maxillary field block would involve the alternate local anesthetic combination. Maxillary molar and canine tested for pulpal anesthesia. | Drug: Lidocaine<br>* Intraoral maxillary field block<br>* Other names: xylocaine;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Time to Pulpal Response After Maxillary Molar Anesthesia | Subjects' maxillary molar teeth will be tested before anesthetic and every 30 minutes with cold and electronic pulp test for presence of anesthesia as reported by subjects yes or no. | Every 30 minutes up to 120 minutes Total | 
| Mean Time to Pulpal Response After Maxillary Canine Anesthesia | Subjects' maxillary molar teeth will be tested before anesthetic and every 30 minutes with cold and electronic pulp test for presence of anesthesia as reported by subjects yes or no. | Every 30 minute up to 120 minutes total | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lidocaine, jaw