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Completed

NCT Number: NCT01496846

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

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.

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Key information

Conditions

Irreversible Pulpitis Dental Pulp Diseases Stomatognathic Diseases Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Michigan, School of Dentistry Clinics

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult patients
  • irreversible pulpitis in mandibular molar

Exclusion criteria

  • below 18 years

Treatment and study plan

IANB Articaine

Drug

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

Other names: Articadent (Dentsply Pharmaceutical)

SUP Articaine

Drug

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).

Other names: Articadent (Dentsply Pharmaceutical)

SUP Lidocaine

Drug

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).

Other names: Generic lidocaine (Henry Schein Inc)

Primary outcomes

  1. 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 was given to achieve complete pulpal anesthesia

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Dentsply International

Registry information

Official study title

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

Acronym: ARTIC

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Dec 21, 2011
Registry last updated
Oct 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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