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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01496846
First Posted: December 21, 2011
Last Update Posted: September 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Dentsply International
Information provided by (Responsible Party):
Mathilde Peters, DMD, PhD, University of Michigan
  Purpose

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 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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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 Mathilde Peters, DMD, PhD, University of Michigan:

Primary Outcome Measures:
  • Anesthetic Success Rate of Supplemental Infiltration Injection [ Time Frame: 5 min after injection ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients
  • irreversible pulpitis in mandibular molar

Exclusion Criteria:

  • below 18 years
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Study Director: Tatiana Botero, DDS, MS 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 ( Other Identifier: U-Michigan )
HUM00088384 ( Other Identifier: U-Michigan )
First Submitted: December 9, 2011
First Posted: December 21, 2011
Results First Submitted: July 11, 2017
Results First Posted: September 13, 2017
Last Update Posted: September 13, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Mathilde Peters, DMD, PhD, 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