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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John Nusstein, Ohio State University
ClinicalTrials.gov Identifier:
NCT01574807
First received: April 2, 2012
Last updated: July 9, 2013
Last verified: July 2013

April 2, 2012
July 9, 2013
May 2012
May 2013   (final data collection date for primary outcome measure)
Pulpal anesthesia [ Time Frame: 60 minutes per injection sequence. ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01574807 on ClinicalTrials.gov Archive Site
Pain of injection [ Time Frame: Initial 3 minutes of study. ] [ Designated as safety issue: No ]
A Heft-Parker Visual Analog Scale (VAS) will be used by subjects to rate the pain of injections received at three distinct times - during needle insertion, placement of the needle to target site, and deposition of the anesthetic solution at the target site. This will occur at each appointment during the anesthetic injection phase of treatment (first 3 minutes).
Same as current
Not Provided
Not Provided
 
The Anesthetic Efficacy of 3% Mepivacaine Plus 2% Lidocaine With 1:100,000 Epinephrine for Lower Jaw Dental Injections
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.

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.

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.

Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Pain
Drug: 3% mepivacaine/2% lidocaine with 1:100,000 epinephrine combo
1.8 mL of 3% mepivacaine followed by 1.8 mL of 2% lidocaine with 1:100,000 epinephrine compared to 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.
Experimental: Pulpal anesthesia
Intervention: Drug: 3% mepivacaine/2% lidocaine with 1:100,000 epinephrine combo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
May 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01574807
Endo-Lam2012
No
John Nusstein, Ohio State University
Ohio State University
Not Provided
Principal Investigator: John Nusstein, DDS, MS Chair, Division of Endodontics
Ohio State University
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP