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

NCT ID: NCT01862614

Last Updated: 2021-05-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2014-05-31

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 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.

Detailed Description

Using a crossover design, 80 adult subjects will receive two injections consisting of a primary mandibular first molar infiltration of 1.8 mL of non-buffered 4% articaine with 1:100,000 epinephrine, and 1.8 mL of buffered 4% articaine with 1:100,000 in two separate appointments spaced at least one week apart. With the crossover design, 160 infiltrations will be given for the first molar and each subject will serve as his or her own control. Eighty infiltrations will be administered on the mandibular left side and 80 administered on the mandibular right side. The order of the two 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 (EPT) will be used to test the lower first molar for anesthesia starting 30 seconds after the injection; and testing every 30 seconds for the first five minutes. After five minutes the EPT will be used to test the lower first molar every minute and the contralateral control canine every 5 minutes for a grand total of sixty minutes. The pain of injection and postoperative pain will be recorded in a survey. Patients will report any postoperative pain or discomfort on a Visual Analog Scale (VAS) for three days following each appointment. The data will be statistically analyzed.

Conditions

Anesthetic Effectiveness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Buffered Articaine at 1st Appointment

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

Group Type: EXPERIMENTAL

Buffered Articaine Hydrochloride + Epinephrine

Intervention Type: DRUG

Articaine at 1st Appointment

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

Group Type: ACTIVE_COMPARATOR

Articaine Hydrochloride + Epinephrine

Intervention Type: DRUG

Interventions

Articaine Hydrochloride + Epinephrine

Intervention Type: DRUG

Buffered Articaine Hydrochloride + Epinephrine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• 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

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 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)

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)

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.

Reference Type: BACKGROUND

PMID: 11020760 (View on PubMed)

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

Reference Type: BACKGROUND

Other Identifiers

Buffered Articaine

Identifier Type: -

Identifier Source: org_study_id