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

NCT01567839 | Completed Phase 4 Results

• 1 other identifier: 4% dental local anesthetics
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthetic Effectiveness

Keywords

degree of pulpal anesthesia obtained; primary infiltration in the lower first molar

Outcome Measures

Primary Outcomes (1)

• Successful Pulpal Anesthesia.

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

  60 minutes

Study Arms (3)

4% Lidocaine

EXPERIMENTAL

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

Procedure: Mandibular buccal Infiltration injection

4% Articaine

EXPERIMENTAL

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

Procedure: Mandibular buccal Infiltration injection

4% Prilocaine

EXPERIMENTAL

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

Procedure: Mandibular buccal Infiltration injection

Interventions

Mandibular buccal Infiltration injection PROCEDURE

4% Articaine; 4% Lidocaine; 4% Prilocaine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University College of Dentistry, Postle Hall

Columbus, Ohio, 43210, United States

Location

Related Publications (6)

• 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.

  PMID: 19228214 BACKGROUND

• 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.

  PMID: 16554198 BACKGROUND

• 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.

  PMID: 17670879 BACKGROUND

• 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.

  PMID: 18762633 BACKGROUND

• 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.

  PMID: 18436027 BACKGROUND

• 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.

  PMID: 19654255 BACKGROUND

Limitations and Caveats

No adverse events.

Results Point of Contact

• Title: Dr. John Nusstein
• Organization: The Ohio State University, Division of Endodontics

nusstein.1@osu.edu

614-292-9412

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 28, 2012
• First Posted: March 30, 2012
• Study Start: May 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: May 1, 2013
• Last Updated: January 1, 2014
• Results First Posted: January 1, 2014

Record last verified: 2013-11

Locations

US (1)