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

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ClinicalTrials.gov Identifier: NCT01567839

Recruitment Status : Completed

First Posted : March 30, 2012

Results First Posted : January 1, 2014

Last Update Posted : January 1, 2014

Sponsor:

Information provided by (Responsible Party):

John Nusstein, Ohio State University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Anesthetic Effectiveness	Procedure: Mandibular buccal Infiltration injection	Phase 4

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Triple (Participant, 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.
Study Start Date :	May 2012
Actual Primary Completion Date :	March 2013
Actual Study Completion Date :	May 2013

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01567839

Locations

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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:

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.

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. Epub 2006 Feb 17.

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.

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. Erratum in: J Am Dent Assoc. 2008 Oct;139(10):1312.

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.

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.

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Responsible Party:	John Nusstein, Associate Professor, Ohio State University
ClinicalTrials.gov Identifier:	NCT01567839
Other Study ID Numbers:	4% dental local anesthetics
First Posted:	March 30, 2012 Key Record Dates
Results First Posted:	January 1, 2014
Last Update Posted:	January 1, 2014
Last Verified:	November 2013

Keywords provided by John Nusstein, Ohio State University:


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

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