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

September 27, 2017 updated by: Mathilde Peters, DMD, PhD, University of Michigan

Articaine Versus Lidocaine Supplemental Infiltration Efficacy in Irreversible Pulpitis Mandibular Molars After Failed Inferior Alveolar Nerve Block

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

201

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan, School of Dentistry Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult patients
  • irreversible pulpitis in mandibular molar

Exclusion Criteria:

  • below 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: IANB Articaine
IANB Articaine: Inferior alveolar nerve block (IANB) anesthesia with articaine local anesthetic.
Drug: IANB Articaine
IANB anesthesia given with 1.7cc of 4% articaine, 1:100,000 epinephrine.
Other Names:
  • Articadent (Dentsply Pharmaceutical)
ACTIVE_COMPARATOR: SUP Articaine
SUP Articaine: Supplemental buccal anesthesia (SUP) with articaine local anesthetic after unsuccessful IANB.
Drug: IANB Articaine
IANB anesthesia given with 1.7cc of 4% articaine, 1:100,000 epinephrine.
Other Names:
  • Articadent (Dentsply Pharmaceutical)
Drug: SUP Articaine
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).
Other Names:
  • Articadent (Dentsply Pharmaceutical)
ACTIVE_COMPARATOR: SUP Lidocaine
SUP Lidocaine: Supplemental buccal anesthesia (SUP) with lidocaine local anesthetic after unsuccessful IANB.
Drug: IANB Articaine
IANB anesthesia given with 1.7cc of 4% articaine, 1:100,000 epinephrine.
Other Names:
  • Articadent (Dentsply Pharmaceutical)
Drug: SUP Lidocaine
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).
Other Names:
  • Generic lidocaine (Henry Schein Inc)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 was given to achieve complete pulpal anesthesia
5 min after injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
15 min after injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

Dentsply International

Investigators

  • Study Director: Tatiana Botero, DDS, MS, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (ACTUAL)

February 1, 2016

Study Completion (ACTUAL)

February 1, 2016

Study Registration Dates

First Submitted

December 9, 2011

First Submitted That Met QC Criteria

December 20, 2011

First Posted (ESTIMATE)

December 21, 2011

Study Record Updates

Last Update Posted (ACTUAL)

October 31, 2017

Last Update Submitted That Met QC Criteria

September 27, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PG#N014189
  • HUM00049692 (OTHER: U-Michigan)
  • HUM00088384 (OTHER: U-Michigan)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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