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

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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:
Information provided by (Responsible Party):
John Nusstein, Ohio State University

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.

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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


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




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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01574807


Locations
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United States, Ohio
The Ohio State University College of Dentistry, Postle Hall
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Investigators
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Principal Investigator: John Nusstein, DDS, MS Chair, Division of Endodontics
Publications:
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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    Key Record Dates
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:
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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