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

NCT ID: NCT01567839

Last Updated: 2014-01-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2013-05-31

Brief Summary

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.

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.

Conditions

Anesthetic Effectiveness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: TRIPLE

Study Groups

4% Lidocaine

1.8 mL of 4% lidocaine with 1:100,000 epinephrine

Group Type: EXPERIMENTAL

Mandibular buccal Infiltration injection

Intervention Type: PROCEDURE

4% Articaine

1.8 mL of 4% articaine with 1:100,000 epinephrine

Group Type: EXPERIMENTAL

Mandibular buccal Infiltration injection

Intervention Type: PROCEDURE

4% Prilocaine

1.8 mL of 4% prilocaine with 1:200,000 epinephrine

Group Type: EXPERIMENTAL

Mandibular buccal Infiltration injection

Intervention Type: PROCEDURE

Interventions

Mandibular buccal Infiltration injection

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

John Nusstein

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Ohio State University College of Dentistry, Postle Hall

Columbus, Ohio, United States

Countries

United States

References

Kanaa MD, Whitworth JM, Corbett IP, Meechan JG. Articaine buccal infiltration enhances the effectiveness of lidocaine inferior alveolar nerve block. Int Endod J. 2009 Mar;42(3):238-46. doi: 10.1111/j.1365-2591.2008.01507.x.

Reference Type: BACKGROUND

PMID: 19228214 (View on PubMed)

Kanaa MD, Whitworth JM, Corbett IP, Meechan JG. Articaine and lidocaine mandibular buccal infiltration anesthesia: a prospective randomized double-blind cross-over study. J Endod. 2006 Apr;32(4):296-8. doi: 10.1016/j.joen.2005.09.016. Epub 2006 Feb 17.

Reference Type: BACKGROUND

PMID: 16554198 (View on PubMed)

Robertson D, Nusstein J, Reader A, Beck M, McCartney M. The anesthetic efficacy of articaine in buccal infiltration of mandibular posterior teeth. J Am Dent Assoc. 2007 Aug;138(8):1104-12. doi: 10.14219/jada.archive.2007.0324.

Reference Type: BACKGROUND

PMID: 17670879 (View on PubMed)

Haase A, Reader A, Nusstein J, Beck M, Drum M. Comparing anesthetic efficacy of articaine versus lidocaine as a supplemental buccal infiltration of the mandibular first molar after an inferior alveolar nerve block. J Am Dent Assoc. 2008 Sep;139(9):1228-35. doi: 10.14219/jada.archive.2008.0338.

Reference Type: BACKGROUND

PMID: 18762633 (View on PubMed)

Corbett IP, Kanaa MD, Whitworth JM, Meechan JG. Articaine infiltration for anesthesia of mandibular first molars. J Endod. 2008 May;34(5):514-8. doi: 10.1016/j.joen.2008.02.042.

Reference Type: BACKGROUND

PMID: 18436027 (View on PubMed)

Abdulwahab M, Boynes S, Moore P, Seifikar S, Al-Jazzaf A, Alshuraidah A, Zovko J, Close J. The efficacy of six local anesthetic formulations used for posterior mandibular buccal infiltration anesthesia. J Am Dent Assoc. 2009 Aug;140(8):1018-24. doi: 10.14219/jada.archive.2009.0313.

Reference Type: BACKGROUND

PMID: 19654255 (View on PubMed)

Other Identifiers

4% dental local anesthetics

Identifier Type: -

Identifier Source: org_study_id