Clinical trial NCT01496846
Conditions: Irreversible Pulpitis
Keywords: Articaine Lidocaine Anesthesia, Local Endodontics Molar Dental Pulp Diseases
Sponsor: University of Michigan
Start date: 2011-09-01; Completion date: 2016-02-01
Enrollment: 201 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Arms: arm 1: IANB Articaine: Inferior alveolar nerve block (IANB) anesthesia with articaine local anesthetic. arm 2: SUP Articaine: Supplemental buccal anesthesia (SUP) with articaine local anesthetic after unsuccessful IANB. arm 3: SUP Lidocaine: Supplemental buccal anesthesia (SUP) with lidocaine local anesthetic after unsuccessful IANB.
Interventions: intervention 1: IANB Articaine intervention 2: SUP Articaine intervention 3: SUP Lidocaine
Intervention descriptions: intervention 1: IANB anesthesia given with 1.7cc of 4% articaine, 1:100,000 epinephrine. intervention 2: 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). intervention 3: 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).

Protocol documents: