Phase 4
N=201
Efficacy Study of Articaine Versus Lidocaine as Supplemental Infiltration in Inflamed Molars
Irreversible Pulpitis
Bottom Line
View on ClinicalTrials.gov: NCT01496846 ↗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
| Outcome | Result | p-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
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.