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The Anesthetic Efficacy of 3% Mepivacaine Plus 2% Lidocaine With 1:100,000 Epinephrine for Lower Jaw Dental Injections

Information source: Ohio State University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain

Intervention: 3% mepivacaine/2% lidocaine with 1:100,000 epinephrine combo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Ohio State University

Official(s) and/or principal investigator(s):
John Nusstein, DDS, MS, Principal Investigator, Affiliation: Chair, Division of Endodontics

Summary

The inferior alveolar nerve block (shot) is the most frequently used injection technique for achieving local anesthesia (numbness) for the teeth in the lower jaw. However, this injection does not always result in successful pulpal (tooth) anesthesia (patient felt pain). No study has combined mepivacaine and lidocaine anesthetics (numbing solutions) for this type of injection (shot). The investigators propose to compare an injection of mepivacaine followed by lidocaine to an injection of lidocaine followed by lidocaine to determine if there is a difference in effectiveness.

Clinical Details

Official title: A Prospective, Randomized, Double-blind Study of the Anesthetic Efficacy of 3% Mepivacaine Plus 2% Lidocaine With 1:100,000 Epinephrine for Inferior Alveolar Nerve Blocks.

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Pulpal anesthesia

Secondary outcome: Pain of injection

Detailed description: One hundred adult male and female subjects will randomly receive two sets of inferior alveolar block injections (shots) consisting of an injection of 1. 8 mL of 3% mepivacaine followed by 1. 8 mL of 2% lidocaine with 1: 100,000 epinephrine, and an injection of 1. 8 mL of 2% lidocaine with 1: 100,000 epinephrine followed by 1. 8 mL of 2% lidocaine with 1: 100,000 epinephrine, at two separate appointments spaced at least two weeks apart, in a crossover design. Whether the subject receives the mepivacaine or the lidocaine for the first injection will be determined randomly. The doctor will not know whether the subject receives mepivacaine or lidocaine for the first injection. The subject will not know which anesthetics he/she receives. A pulp tester will be used to test the lower jaw teeth (molars, premolars, and incisors) for anesthesia (numbness) in 4-minute time cycles for 60 minutes. The pain of the IAN block injections will also be recorded. The data will be statistically analyzed.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- between the ages of 18 and 65 years

- good health (ASA classification I or II)

- able to provide informed consent

Exclusion Criteria:

- allergy to lidocaine or mepivacaine

- history of significant medical problem (ASA classification III or greater)

- depression

- have taken CNS depressants (including alcohol or any analgesic medications) within

the last 48 hours

- lactating or pregnant

- inability to give informed consent

Locations and Contacts

The Ohio State University College of Dentistry, Postle Hall, Columbus, Ohio 43210, United States
Additional Information

Related publications:

Nusstein J, Reader A, Beck FM. Anesthetic efficacy of different volumes of lidocaine with epinephrine for inferior alveolar nerve blocks. Gen Dent. 2002 Jul-Aug;50(4):372-5; quiz 376-7.

McLean C, Reader A, Beck M, Meryers WJ. An evaluation of 4% prilocaine and 3% mepivacaine compared with 2% lidocaine (1:100,000 epinephrine) for inferior alveolar nerve block. J Endod. 1993 Mar;19(3):146-50.

Cohen HP, Cha BY, SpÄngberg LS. Endodontic anesthesia in mandibular molars: a clinical study. J Endod. 1993 Jul;19(7):370-3.

Rood JP, Caruana PE, Danford M, Pateromichelakis S. Prilocaine -- an investigation into its use in the presence of inflammation and in combination with lignocaine. J Dent. 1981 Sep;9(3):240-7.

Starting date: May 2012
Last updated: July 9, 2013

Page last updated: August 23, 2015

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