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

The Ohio State University

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: lidocaine + lidocaine followed by mepivacaine + lidocaine; Drug: mepivacaine + lidocaine followed by lidocaine +lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01574807

Endo-Lam2012

Details and patient eligibility

About

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.

Full description

One hundred adult male and female subjects will randomly receive two sets of inferior alveolar block injections (shots) consisting of; 1.) an injection of 1.8 mL of 3% mepivacaine followed by 1.8 mL of 2% lidocaine with 1:100,000 epinephrine, and 2.) 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 data will be statistically analyzed.

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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100 participants in 2 patient groups

mepivacaine + lidocaine followed by lidocaine + lidocaine

Experimental group

Description:

A repeated measures design utilizing a single group of subjects was employed with each subject serving as his/her own control. Each subject received two interventions: 1.) 1.8 cc 3% mepivacaine and 1.8 cc 2% lidocaine with 1:100,000 epinephrine (3% mepivacaine/2% lidocaine with epinephrine - combination 1) and 2.) 1.8 cc 2% lidocaine with 1:100,000 epinephrine followed by 1.8 cc 2% liocaine with 1:100,000 epinephrine at two seperate appointments spaced 2 weeks apart.

Treatment:

Drug: mepivacaine + lidocaine followed by lidocaine +lidocaine

lidocaine + lidocaine followed by mepivacaine plus lidocaine

Experimental group

Description:

A repeated measures design utilizing a single group of subjects was employed with each subject serving as his/her own control. Each subject received two interventions: 1.) 1.8 cc 2% lidocaine with 1:100,000 epinephrine and 1.8 cc 2% lidocaine with 1:100,000 epinephrine and 2.) 1.8 cc 3% mepivacaine and 1.8 cc 2% lidocaine with 1:100,000 epinephrine followed by 1.8 cc 2% liocaine with 1:100,000 epinephrine at two separate appointments spaced two weeks apart.

Treatment:

Drug: lidocaine + lidocaine followed by mepivacaine + lidocaine