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

This study has been completed.
Sponsor:
Collaborator:
Dentsply International
Information provided by (Responsible Party):
Mathilde Peters, DMD, PhD, University of Michigan
ClinicalTrials.gov Identifier:
NCT01496846
First received: December 9, 2011
Last updated: March 30, 2016
Last verified: March 2016
  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 pulpits.

This study consisted of two periods of patient enrollment, treatment and data collection: Part I: 101 subjects; Part II: 100 subjects.


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:


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


Enrollment: 201
Study Start Date: September 2011
Study Completion Date: February 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Articaine
Supplemental buccal anesthesia with articaine local anesthetic 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
Supplemental buccal anesthesia with lidocaine local anesthetic 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 proposed randomized controlled trial (RCT) aims to answer the following questions:

  1. What is the success rate of an IANB with articaine using a conventional IANB technique and standardized speed of administration?
  2. Is there a difference in complete pulpal anesthetic efficacy using supplemental infiltration with either articaine or lidocaine after an unsuccessful articaine IANB?
  3. Is there a difference in first or second molars in achieving complete pulpal anesthesia using supplemental infiltration with either articaine or lidocaine?

This study will combine the data from HUM00049692- Articaine Efficacy in Inflamed Molars to create a larger sample size, giving a total sample size of approximately 200 patients.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Peters, DMD, PhD, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT01496846     History of Changes
Other Study ID Numbers: PG#N014189  HUM00049692  HUM00088384 
Study First Received: December 9, 2011
Last Updated: March 30, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Undecided

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
Lidocaine
Anesthetics, Local
Carticaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2016