Efficacy Study of Articaine Versus Lidocaine as Supplemental Infiltration in Inflamed Molars (ARTIC)
The purpose of this study 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.
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.
|Irreversible Pulpitis||Drug: Articaine local anesthetic Drug: Lidocaine local anesthetic||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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|
- 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
- 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
|Study Start Date:||September 2011|
|Study Completion Date:||February 2016|
|Primary Completion Date:||February 2016 (Final data collection date for primary outcome measure)|
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)
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:
- What is the success rate of an IANB with articaine using a conventional IANB technique and standardized speed of administration?
- Is there a difference in complete pulpal anesthetic efficacy using supplemental infiltration with either articaine or lidocaine after an unsuccessful articaine IANB?
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01496846
|United States, Michigan|
|University of Michigan, School of Dentistry Clinics|
|Ann Arbor, Michigan, United States, 48109|
|Study Chair:||Mathilde C Peters, DMD, PhD||University of Michigan|