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

Not Applicable

Completed

• Conditions: Anesthesia
• Interventions: Drug: Lidocaine

• Registration Number: NCT02747186
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Study Timeline

• Study First Submitted: 2016-04-19
• Study First Submitted QC: 2016-04-20
• Study First Posted: 2016-04-21
• Study Start: 2016-05
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Status Verified: 2018-10
• Results First Submitted: 2018-10-11
• Results First Submitted QC: 2018-11-28
• Last Update Submitted: 2018-11-28
• Results First Posted: 2018-12-19
• Last Update Posted: 2018-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Buffered 1% lidocaine	Lidocaine	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.
Non-Buffered lidocaine	Lidocaine	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.

Primary Outcome Measures

Name	Time	Method
Mean Time to Pulpal Response After Maxillary Molar Anesthesia	Every 30 minutes up to 120 minutes Total	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.
Mean Time to Pulpal Response After Maxillary Canine Anesthesia	Every 30 minute up to 120 minutes total	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.

Trial Locations

Locations (1)

University of North Carolina School of Dentistry; 🇺🇸 Chapel Hill, North Carolina, United States