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

University of Michigan

Status and phase: Completed; Phase 4

Conditions: Irreversible Pulpitis

Treatments: Drug: IANB Articaine; Drug: SUP Articaine; Drug: SUP Lidocaine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01496846

HUM00088384 (Other Identifier)

PG#N014189

HUM00049692 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 201 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients
• irreversible pulpitis in mandibular molar

Exclusion criteria

• below 18 years

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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201 participants in 3 patient groups

IANB Articaine

Active Comparator group

Description:

IANB Articaine: Inferior alveolar nerve block (IANB) anesthesia with articaine local anesthetic.

Treatment:

Drug: IANB Articaine

SUP Articaine

Active Comparator group

Description:

SUP Articaine: Supplemental buccal anesthesia (SUP) with articaine local anesthetic after unsuccessful IANB.

Treatment:

Drug: SUP Articaine

Drug: IANB Articaine

SUP Lidocaine

Active Comparator group

Description:

SUP Lidocaine: Supplemental buccal anesthesia (SUP) with lidocaine local anesthetic after unsuccessful IANB.

Treatment:

Drug: SUP Lidocaine

Drug: IANB Articaine