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

Phase 4

Completed

• Conditions: Irreversible Pulpitis
• Interventions: Drug: IANB Articaine; Drug: SUP Lidocaine; Drug: SUP Articaine

• Registration Number: NCT01496846
• Lead Sponsor: University of Michigan

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-12-09
• Study First Submitted QC: 2011-12-20
• Study First Posted: 2011-12-21
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Results First Submitted: 2017-07-11
• Results First Submitted QC: 2017-08-09
• Status Verified: 2017-09
• Results First Posted: 2017-09-13
• Last Update Submitted: 2017-09-27
• Last Update Posted: 2017-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

Inclusion Criteria

• adult patients
• irreversible pulpitis in mandibular molar

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Exclusion Criteria

• below 18 years

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IANB Articaine	IANB Articaine	IANB Articaine: Inferior alveolar nerve block (IANB) anesthesia with articaine local anesthetic.
SUP Lidocaine	IANB Articaine	SUP Lidocaine: Supplemental buccal anesthesia (SUP) with lidocaine local anesthetic after unsuccessful IANB.
SUP Lidocaine	SUP Lidocaine	SUP Lidocaine: Supplemental buccal anesthesia (SUP) with lidocaine local anesthetic after unsuccessful IANB.
SUP Articaine	IANB Articaine	SUP Articaine: Supplemental buccal anesthesia (SUP) with articaine local anesthetic after unsuccessful IANB.
SUP Articaine	SUP Articaine	SUP Articaine: Supplemental buccal anesthesia (SUP) with articaine local anesthetic after unsuccessful IANB.

Primary Outcome Measures

Name	Time	Method
Anesthetic Success Rate of Supplemental Infiltration Injection	5 min after injection	Following an unsuccessful IANB, supplemental infiltration anesthesia with either articaine or lidocaine was given to achieve complete pulpal anesthesia

Secondary Outcome Measures

Name	Time	Method
Anesthetic Success Rate of an IANB With Articaine	15 min after injection	Success rate of an IANB with articaine using a conventional IANB technique

Trial Locations

Locations (1)

University of Michigan, School of Dentistry Clinics; 🇺🇸 Ann Arbor, Michigan, United States