Testing the Anesthetic Effectiveness of Three Different Dental Local Anesthetics Injected Next to a Lower First Molar

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John Nusstein, Ohio State University
ClinicalTrials.gov Identifier:
NCT01567839
First received: March 28, 2012
Last updated: November 7, 2013
Last verified: November 2013

March 28, 2012
November 7, 2013
May 2012
March 2013   (final data collection date for primary outcome measure)
Successful Pulpal Anesthesia. [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
Two consecutive 80/80 readings (no patient response) during 60 minutes of testing with an electric pulp tester.
Not Provided
Complete list of historical versions of study NCT01567839 on ClinicalTrials.gov Archive Site
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Testing the Anesthetic Effectiveness of Three Different Dental Local Anesthetics Injected Next to a Lower First Molar
Anesthetic Efficacy of 4% Articaine With 1:100,000 Epinephrine, 4% Prilocaine With 1:200,000 Epinephrine, and 4% Lidocaine With 1:100,000 Epinephrine as a Primary Buccal Infiltration in the Mandibular First Molar.

Infiltration (injecting next to the tooth) injections are common in dentistry and a number of studies have shown that articaine anesthetic, when injected next to the tooth as a supplemental injection, works very well following a typical inferior alveolar (lower jaw) nerve block. No study has compared 4% articaine with 1:100,000 epinephrine, 4% prilocaine with 1:200,000 epinephrine, and 4% lidocaine with 1:100,000 epinephrine in mandibular (lower jaw) infiltration injections of the first molar. The purpose of this prospective, randomized, double-blind, crossover study is to compare the degree of anesthesia obtained from the three solutions as a primary infiltration injection next to the mandibular first molar. The investigators also will record the pain of injection and postoperative pain.

Using a crossover design, 60 adult subjects will receive three injections consisting of a primary mandibular first molar infiltration of 1.8 mL of 4% articaine with 1:100,000 epinephrine, 1.8 mL of 4% prilocaine with 1:200,000 epinephrine, and 1.8 mL of 4% lidocaine with 1:100,000 epinephrine in three separate appointments spaced at least one week apart. With the crossover design, 180 infiltrations will be given for the first molar and each subject will serve as his or her own control. Ninety infiltrations will be administered on the mandibular left side and ninety administered on the mandibular right side. The order of the three injections will be assigned randomly and the dentist and subject will be blinded about which anesthetic the subject is given. The anesthetics used in this study are not experimental. An electric pulp tester will be used to test the lower back teeth (molars and premolars) for anesthesia in 3-minute time intervals for a total of 60 minutes. The pain of injection and postoperative pain will be recorded in a survey. The data will be statistically analyzed.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Anesthetic Effectiveness
Procedure: Mandibular buccal Infiltration injection
  • Experimental: 4% Lidocaine
    1.8 mL of 4% lidocaine with 1:100,000 epinephrine
    Intervention: Procedure: Mandibular buccal Infiltration injection
  • Experimental: 4% Articaine
    1.8 mL of 4% articaine with 1:100,000 epinephrine
    Intervention: Procedure: Mandibular buccal Infiltration injection
  • Experimental: 4% Prilocaine
    1.8 mL of 4% prilocaine with 1:200,000 epinephrine
    Intervention: Procedure: Mandibular buccal Infiltration injection

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
May 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • between the ages of 18 and 65 years.
  • in good health (ASA classification II or lower).
  • able to provide informed consent.

Exclusion Criteria:

  • allergy to articaine, lidocaine or prilocaine.
  • history of significant medical problems (ASA classification III or greater).
  • depression (taking tri-cyclic antidepressant medications to control).
  • have taken CNS depressants (including alcohol or any analgesic medications) within the last 48 hours prior to testing.
  • 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
 
NCT01567839
4% dental local anesthetics
No
John Nusstein, Ohio State University
Ohio State University
Not Provided
Not Provided
Ohio State University
November 2013

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