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

Irreversible Pulpitis Clinical Trial

— ARTIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01496846
• Other study ID #: PG#N014189
• Secondary ID: HUM00049692HUM00
• Status: Completed
• Phase: Phase 4
• First received: December 9, 2011
• Last updated: September 27, 2017
• Start date: September 2011
• Est. completion date: February 2016

Study information

• Verified date: September 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients

• irreversible pulpitis in mandibular molar

Exclusion Criteria:

• below 18 years

Related Conditions & MeSH terms

• Irreversible Pulpitis
• Pulpitis

Intervention

Drug:
• IANB Articaine
IANB anesthesia given with 1.7cc of 4% articaine, 1:100,000 epinephrine.
• 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).
• 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).

Locations

Country	Name	City	State
United States	University of Michigan, School of Dentistry Clinics	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Dentsply International

Country where clinical trial is conducted

United States, 

References & Publications (4)

Brandt RG, Anderson PF, McDonald NJ, Sohn W, Peters MC. The pulpal anesthetic efficacy of articaine versus lidocaine in dentistry: a meta-analysis. J Am Dent Assoc. 2011 May;142(5):493-504. — View Citation

Rogers BS, Botero TM, McDonald NJ, Gardner RJ, Peters MC. Efficacy of articaine versus lidocaine as a supplemental buccal infiltration in mandibular molars with irreversible pulpitis: a prospective, randomized, double-blind study. J Endod. 2014 Jun;40(6): — View Citation

Rogers BS, McDonald NJ, Gardner R, Botero T, Shlafer M, Peters MC. Anesthetic Efficacy of Articaine vs Lidocaine as Supplemental Infiltration after Unsuccessful IANB of Irreversible Pulpitis Mandibular Molars. AAE Annual Meeting. Honolulu, Hawaii, April 2

Shapiro MR, McDonald NJ, Gardner RJ, Peters MC, Botero TM. Efficacy of Articaine versus Lidocaine In Supplemental Infiltration For Mandibular First versus Second Molars with Irreversible Pulpitis. J Endod, under review (Sep 2017).

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anesthetic Success Rate of Supplemental Infiltration 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	Anesthetic Success Rate of an IANB With Articaine	Success rate of an IANB with articaine using a conventional IANB technique	15 min after injection