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
  Purpose

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.


Condition Intervention Phase
Anesthetic Effectiveness
Procedure: Mandibular buccal Infiltration injection
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • 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.


Enrollment: 60
Study Start Date: May 2012
Study Completion Date: May 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 4% Lidocaine
1.8 mL of 4% lidocaine with 1:100,000 epinephrine
Procedure: Mandibular buccal Infiltration injection
Experimental: 4% Articaine
1.8 mL of 4% articaine with 1:100,000 epinephrine
Procedure: Mandibular buccal Infiltration injection
Experimental: 4% Prilocaine
1.8 mL of 4% prilocaine with 1:200,000 epinephrine
Procedure: Mandibular buccal Infiltration injection

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01567839

Locations
United States, Ohio
The Ohio State University College of Dentistry, Postle Hall
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
  More Information

Publications:
Responsible Party: John Nusstein, Associate Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT01567839     History of Changes
Other Study ID Numbers: 4% dental local anesthetics
Study First Received: March 28, 2012
Results First Received: June 24, 2013
Last Updated: November 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
degree of pulpal anesthesia obtained
primary infiltration in the lower first molar

Additional relevant MeSH terms:
Lidocaine
Prilocaine
Anesthetics
Epinephrine
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on September 16, 2014