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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Dentsply International
Information provided by (Responsible Party):
Mathilde C Peters, University of Michigan
ClinicalTrials.gov Identifier:
NCT01496846
First received: December 9, 2011
Last updated: December 20, 2011
Last verified: December 2011
History of Changes
  Purpose

The purpose of this study 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 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.

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 pulpitis.


Condition Intervention Phase
Irreversible Pulpitis
 Drug: Articaine local anesthetic
Drug: Lidocaine local anesthetic
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Articaine Versus Lidocaine Supplemental Infiltration Efficacy in Irreversible Pulpitis Mandibular Molars After Failed Inferior Alveolar Nerve Block

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Anesthetic success rate of supplemental infiltration injection [ Time Frame: 5 min after injection ] [ Designated as safety issue: No ]
    Following an unsuccessful IANB, supplemental infiltration anesthesia with either articaine or lidocaine will be given to achieve complete pulpal anesthesia


Secondary Outcome Measures:
  • Anesthetic success rate of an IANB with articaine [ Time Frame: 15 min after injection ] [ Designated as safety issue: No ]
    Success rate of an IANB with articaine using a conventional IANB technique


Estimated Enrollment: 120
Study Start Date: September 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Articaine
Articaine supplemental anesthesia after unsuccessful IANB.
 Drug: Articaine local anesthetic
After unsuccessful IANB, proceed to give 1.7cc of either 4% articaine with 1:100,000 epinephrine in buccal mucosa as a supplemental infiltration injection
Other Name: Articadent (Dentsply Pharmaceutical)
Active Comparator: Lidocaine
Lidocaine supplemental anesthesia after unsuccessful IANB.
 Drug: Lidocaine local anesthetic
After unsuccessful IANB, proceed to give 1.7cc 2% lidocaine with 1:100,000 epinephrine in buccal mucosa as a supplemental infiltration injection
Other Name: Generic lidocaine (Henry Schein Inc)

Detailed Description:

The goal of the study is to achieve complete pulpal anesthesia in irreversible pulpitis mandibular molars, either by IANB administration of 4% articaine with 1:100,000 epinephrine (NDA 022466), or in case the IANB appeared to be clinically unsuccessful by supplemental infiltration of either articaine or lidocaine.

The investigators hypothesize that an inferior alveolar nerve block with articaine in irreversible pulpitis mandibular molars will yield a complete pulpal success rate greater than 30 percent.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients
  • irreversible pulpitis in mandibular molar

Exclusion Criteria:

  • below 18 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01496846

Locations
United States, Michigan
University of Michigan, School of Dentistry Clinics
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Dentsply International
Investigators
Study Chair: Mathilde C Peters, DMD, PhD University of Michigan
  More Information

Publications:

Responsible Party: Mathilde C Peters, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT01496846     History of Changes
Other Study ID Numbers: PG#N014189, 12-PAF00612
Study First Received: December 9, 2011
Last Updated: December 20, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Articaine
Lidocaine
Anesthesia, Local
 Endodontics
Molar
Dental Pulp Diseases

Additional relevant MeSH terms:
Pulpitis
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Anesthetics, Local
Carticaine
Lidocaine
Anesthetics
Central Nervous System Depressants
 Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 23, 2013