Testing the Anesthetic Effectiveness of Three Different Dental Local Anesthetics Injected Next to a Lower First Molar

Phase 4

Completed

• Conditions: Anesthetic Effectiveness
• Interventions: Procedure: Mandibular buccal Infiltration injection

• Registration Number: NCT01567839
• Lead Sponsor: Ohio State University

Brief Summary

Infiltration (injecting next to the tooth) injections are common in dentistry and a number of studies have shown that articaine anesthetic, when injected next to the tooth as a supplemental injection, works very well following a typical inferior alveolar (lower jaw) nerve block. No study has compared 4% articaine with 1:100,000 epinephrine, 4% prilocaine with 1:200,000 epinephrine, and 4% lidocaine with 1:100,000 epinephrine in mandibular (lower jaw) infiltration injections of the first molar. The purpose of this prospective, randomized, double-blind, crossover study is to compare the degree of anesthesia obtained from the three solutions as a primary infiltration injection next to the mandibular first molar. The investigators also will record the pain of injection and postoperative pain.

Detailed Description

Using a crossover design, 60 adult subjects will receive three injections consisting of a primary mandibular first molar infiltration of 1.8 mL of 4% articaine with 1:100,000 epinephrine, 1.8 mL of 4% prilocaine with 1:200,000 epinephrine, and 1.8 mL of 4% lidocaine with 1:100,000 epinephrine in three separate appointments spaced at least one week apart. With the crossover design, 180 infiltrations will be given for the first molar and each subject will serve as his or her own control. Ninety infiltrations will be administered on the mandibular left side and ninety administered on the mandibular right side. The order of the three injections will be assigned randomly and the dentist and subject will be blinded about which anesthetic the subject is given. The anesthetics used in this study are not experimental. An electric pulp tester will be used to test the lower back teeth (molars and premolars) for anesthesia in 3-minute time intervals for a total of 60 minutes. The pain of injection and postoperative pain will be recorded in a survey. The data will be statistically analyzed.

Study Timeline

• Study First Submitted: 2012-03-28
• Study First Submitted QC: 2012-03-29
• Study First Posted: 2012-03-30
• Study Start: 2012-05
• Primary Completion: 2013-03
• Study Completion: 2013-05
• Results First Submitted: 2013-06-24
• Status Verified: 2013-11
• Results First Submitted QC: 2013-11-07
• Last Update Submitted: 2013-11-07
• Results First Posted: 2014-01-01
• Last Update Posted: 2014-01-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• between the ages of 18 and 65 years.
• in good health (ASA classification II or lower).
• able to provide informed consent.

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Exclusion Criteria

• allergy to articaine, lidocaine or prilocaine.
• history of significant medical problems (ASA classification III or greater).
• depression (taking tri-cyclic antidepressant medications to control).
• have taken CNS depressants (including alcohol or any analgesic medications) within the last 48 hours prior to testing.
• lactating or pregnant.
• inability to give informed consent.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
4% Lidocaine	Mandibular buccal Infiltration injection	1.8 mL of 4% lidocaine with 1:100,000 epinephrine
4% Articaine	Mandibular buccal Infiltration injection	1.8 mL of 4% articaine with 1:100,000 epinephrine
4% Prilocaine	Mandibular buccal Infiltration injection	1.8 mL of 4% prilocaine with 1:200,000 epinephrine

Primary Outcome Measures

Name	Time	Method
Successful Pulpal Anesthesia.	60 minutes	Two consecutive 80/80 readings (no patient response) during 60 minutes of testing with an electric pulp tester.

Trial Locations

Locations (1)

The Ohio State University College of Dentistry, Postle Hall; 🇺🇸 Columbus, Ohio, United States