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
|