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Phase 4 N=201 Randomized Triple-blind Treatment

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

Irreversible Pulpitis

Enrolled (actual)
201
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcome: Primary: Anesthetic Success Rate of Supplemental Infiltration Injection — 22; 25; 23; 12 Participants — p=.901

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
IANB Articaine (Drug); SUP Articaine (Drug); SUP Lidocaine (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Michigan
Primary completion
Feb 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Anesthetic Success Rate of Supplemental Infiltration Injection
22; 25; 23; 12 .901
SECONDARY
Anesthetic Success Rate of an IANB With Articaine
27; 23 .437

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.

Eligibility Criteria

Inclusion Criteria

  • adult patients
  • irreversible pulpitis in mandibular molar

Exclusion Criteria

  • below 18 years
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01496846). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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