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

• ClinicalTrials.gov Identifier: NCT01574807
• Recruitment Status: Completed
• First Posted: April 10, 2012
• Results First Posted: November 17, 2020
• Last Update Posted: November 17, 2020
• Sponsor: Ohio State University
• Information provided by (Responsible Party): John Nusstein, Ohio State University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Pain	Drug: mepivacaine + lidocaine followed by lidocaine +lidocaine; Drug: lidocaine + lidocaine followed by mepivacaine + lidocaine	Phase 4

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: May 2012
• Actual Primary Completion Date: May 2013
• Actual Study Completion Date: May 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: mepivacaine + lidocaine followed by lidocaine + lidocaine; 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.	Drug: mepivacaine + lidocaine followed by lidocaine +lidocaine; 1.8 mL of 3% mepivacaine followed by 1.8 mL of 2% lidocaine with 1:100,000 epinephrine followed by 1.8 mL of 2% lidocaine with 1:100,000 epinephrine followed by 1.8 mL of 2% lidocaine with 1:100,000 epinephrine; Other Name: Combo 1
Experimental: lidocaine + lidocaine followed by mepivacaine plus lidocaine; 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.	Drug: lidocaine + lidocaine followed by mepivacaine + lidocaine; 1.8 mL of 2% lidocaine with 1:100,000 epinephrine followed by 1.8 mL of 2% lidocaine with 1:100,000 epinephrine followed by 1.8 mL of 3% mepivacaine followed by 1.8 mL of 2% lidocaine with 1:100,000 epinephrine; Other Name: Combo 2

Outcome Measures

Primary Outcome Measures :

1. Number of Participants Achieving Pulpal Anesthesia Success. [ Time Frame: 60 minutes per injection sequence. ]
   An electric 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. Measurements of less than 80 on the EPT is considered not numb (anesthesia failure). Readings of 80 equate to anesthetic success.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Ohio

The Ohio State University College of Dentistry, Postle Hall

Columbus, Ohio, United States, 43210

Sponsors and Collaborators

Ohio State University

Investigators

• Principal Investigator: John Nusstein, DDS, MS; Chair, Division of Endodontics

More Information

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, Spångberg 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.

• Responsible Party: John Nusstein, Associate Professor and Chair, Divison of Endodontics, Ohio State University
• ClinicalTrials.gov Identifier: NCT01574807
• Other Study ID Numbers: Endo-Lam2012
• First Posted: April 10, 2012
• Results First Posted: November 17, 2020
• Last Update Posted: November 17, 2020
• Last Verified: November 2020

Keywords provided by John Nusstein, Ohio State University:

mepivacaine; lidocaine; inferior alveolar nerve block; pulpal anesthesia; mepivacaine/lidocaine; lidocaine/lidocaine

Additional relevant MeSH terms:

Lidocaine; Mepivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action