Testing the Anesthetic Effectiveness of Buffered Articaine Injected Next to a Lower First Molar.

NCT01862614 | Completed Phase 4 Results

• 1 other identifier: Buffered Articaine
• Study Type: interventional
• Target: 80
• 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 a lower molar, is more effective than a local anesthetic injection of lidocaine. However success rates have not been as high as hoped for. No objective study has addressed the success rate of buffering articaine in a mandibular primary buccal infiltration of the first molar. Therefore, the purpose of this prospective, randomized, double-blind, crossover study is to compare the degree of pulpal anesthesia obtained with a buffered 4% articaine with 1:100,000 epinephrine solution versus a non-buffered 4% articaine with 1:100,000 epinephrine solution as a primary infiltration in the mandibular first molar. The investigators will also record the pain of injection and postoperative pain.

Conditions

Anesthetic Effectiveness

Keywords

Degree of pulpal anesthesia obtained.; Primary infiltration in the lower first molar.; Buffered local anesthetic.

Outcome Measures

Primary Outcomes (1)

• Number of Participants Achieving Pulpal Anesthesia.

  An electric pulp tester will be used to test the lower jaw teeth (molars, premolars, and incisors) for anesthesia (numbness) in 4-minute time cycles for 60 minutes. Measurements of less than 80 on the EPT is considered not numb (anesthesia failure). Readings of 80 equate to anesthetic success.

  60 minutes per injection sequence.

Study Arms (2)

Buffered Articaine at 1st Appointment

EXPERIMENTAL

Subjects received an infiltration injection of 1.8cc buffered 4% articaine.

Drug: Buffered Articaine Hydrochloride + Epinephrine

Articaine at 1st Appointment

ACTIVE COMPARATOR

Subjects received an infiltration injection of 1.8cc 4% articaine (unbuffered).

Drug: Articaine Hydrochloride + Epinephrine

Interventions

Articaine Hydrochloride + Epinephrine DRUG

Articaine at 1st Appointment

Buffered Articaine Hydrochloride + Epinephrine DRUG

Buffered Articaine at 1st Appointment

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 age of 18-65 years.
• in good health (ASA classification II or higher).
• able to provide informed consent.

You may not qualify if:

• allergy to articaine.
• history of significant medical problems (ASA classification of III or worse).
• diagnosed depression (taking tri-cyclic antidepressant medications to control).
• have taken central nervous system (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 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

• 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

• Sinnott CJ, Garfield JM, Thalhammer JG, Strichartz GR. Addition of sodium bicarbonate to lidocaine decreases the duration of peripheral nerve block in the rat. Anesthesiology. 2000 Oct;93(4):1045-52. doi: 10.1097/00000542-200010000-00028.

  PMID: 11020760 BACKGROUND

• Burmeister CH. A practical method for the extemporaneous preparations of a buffered anesthetic solution. J Am Dent Assoc 22:1514, 1935.

  BACKGROUND

MeSH Terms

Interventions

Carticaine; Epinephrine

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Dr. John Nusstein, Professor
• Organization: The Ohio State University College of Dentistry

nusstein.1@osu.edu

614-292-3596

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 22, 2013
• First Posted: May 24, 2013
• Study Start: April 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 26, 2021
• Results First Posted: December 2, 2020

Record last verified: 2021-05

Locations

US (1)