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Completed

NCT Number: NCT01567839

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Ohio State University College of Dentistry, Postle Hall

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mandibular buccal Infiltration injection

Procedure

Primary outcomes

  1. Successful Pulpal Anesthesia.

    Time frame: 60 minutes

    Two consecutive 80/80 readings (no patient response) during 60 minutes of testing with an electric pulp tester.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study 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.

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 30, 2012
Registry last updated
Jan 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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