Efficacy Study of Articaine Versus Lidocaine as Supplemental Infiltration in Inflamed Molars

NCT01496846 | Completed Phase 4 Results

• 3 other identifiers: PG#N014189HUM00049692HUM00088384
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to study the ability of a frequently used dental anesthetic (articaine) to achieve complete numbness of a diseased tooth with the most commonly used injection technique in the lower jaw (inferior alveolar nerve block: IANB). If this technique fails, a commonly used supplemental (SUP) technique with one of two possible dental anesthetics (lidocaine or articaine) will be given to evaluate the success/failure of complete numbness between the two anesthetics. Standardized administration of anesthesia is provided by controlled delivery using Midwest Comfort Control Syringe. The investigators hypothesize that supplemental infiltration anesthesia with articaine will give the same success rate as lidocaine in achieving complete pulpal anesthesia in mandibular molars with irreversible pulpits. This study consisted of two periods of patient enrollment, treatment and data collection: Part I: 101 subjects; Part II: 100 subjects.

Conditions

Irreversible Pulpitis

Keywords

Articaine; Lidocaine; Anesthesia, Local; Endodontics; Molar; Dental Pulp Diseases

Outcome Measures

Primary Outcomes (1)

• Anesthetic Success Rate of Supplemental Infiltration Injection

  Following an unsuccessful IANB, supplemental infiltration anesthesia with either articaine or lidocaine was given to achieve complete pulpal anesthesia

  5 min after injection

Secondary Outcomes (1)

• Anesthetic Success Rate of an IANB With Articaine

  15 min after injection

Study Arms (3)

IANB Articaine

ACTIVE COMPARATOR

IANB Articaine: Inferior alveolar nerve block (IANB) anesthesia with articaine local anesthetic.

Drug: IANB Articaine

SUP Articaine

ACTIVE COMPARATOR

SUP Articaine: Supplemental buccal anesthesia (SUP) with articaine local anesthetic after unsuccessful IANB.

Drug: IANB Articaine; Drug: SUP Articaine

SUP Lidocaine

ACTIVE COMPARATOR

SUP Lidocaine: Supplemental buccal anesthesia (SUP) with lidocaine local anesthetic after unsuccessful IANB.

Drug: IANB Articaine; Drug: SUP Lidocaine

Interventions

IANB Articaine DRUG

IANB anesthesia given with 1.7cc of 4% articaine, 1:100,000 epinephrine.

Also known as: Articadent (Dentsply Pharmaceutical)

IANB Articaine; SUP Articaine; SUP Lidocaine

SUP Articaine DRUG

After unsuccessful IANB with articaine, proceed to give 1.7cc of 4% articaine with 1:100,000 epinephrine in buccal mucosa as a supplemental infiltration injection (SUP).

Also known as: Articadent (Dentsply Pharmaceutical)

SUP Articaine

SUP Lidocaine DRUG

After unsuccessful IANB with articaine, proceed to give 1.7cc of 2% lidocaine with 1:100,000 epinephrine in buccal mucosa as a supplemental infiltration injection (SUP).

Also known as: Generic lidocaine (Henry Schein Inc)

SUP Lidocaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients
• irreversible pulpitis in mandibular molar

You may not qualify if:

• below 18 years

Sponsors & Collaborators

• University of Michigan: lead
• Dentsply International: collaborator

Study Sites (1)

University of Michigan, School of Dentistry Clinics

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (4)

• Brandt RG, Anderson PF, McDonald NJ, Sohn W, Peters MC. The pulpal anesthetic efficacy of articaine versus lidocaine in dentistry: a meta-analysis. J Am Dent Assoc. 2011 May;142(5):493-504. doi: 10.14219/jada.archive.2011.0219.

  PMID: 21531931 BACKGROUND

• Rogers BS, McDonald NJ, Gardner R, Botero T, Shlafer M, Peters MC. Anesthetic Efficacy of Articaine vs Lidocaine as Supplemental Infiltration after Unsuccessful IANB of Irreversible Pulpitis Mandibular Molars. AAE Annual Meeting. Honolulu, Hawaii, April 2013.

  RESULT

• Rogers BS, Botero TM, McDonald NJ, Gardner RJ, Peters MC. Efficacy of articaine versus lidocaine as a supplemental buccal infiltration in mandibular molars with irreversible pulpitis: a prospective, randomized, double-blind study. J Endod. 2014 Jun;40(6):753-8. doi: 10.1016/j.joen.2013.12.022. Epub 2014 Feb 8.

  PMID: 24862701 RESULT

• Shapiro MR, McDonald NJ, Gardner RJ, Peters MC, Botero TM. Efficacy of Articaine versus Lidocaine in Supplemental Infiltration for Mandibular First versus Second Molars with Irreversible Pulpitis: A Prospective, Randomized, Double-blind Clinical Trial. J Endod. 2018 Apr;44(4):523-528. doi: 10.1016/j.joen.2017.10.003. Epub 2018 Feb 1.

  PMID: 29397214 RESULT

MeSH Terms

Conditions

Dental Pulp Diseases

Interventions

Carticaine

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr Tatiana Botero, Director of Postgraduate Program in Endodontics
• Organization: University of Michigan

tbotero@umich.edu

734-936-2526

Study Officials

• Mathilde C Peters, DMD, PhD

  University of Michigan

  STUDY CHAIR

• Tatiana Botero, DDS, MS

  University of Michigan

  STUDY DIRECTOR

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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 9, 2011
• First Posted: December 21, 2011
• Study Start: September 1, 2011
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: October 31, 2017
• Results First Posted: September 13, 2017

Record last verified: 2017-09

Locations

US (1)