Phase 4
N=64
Comparison of Two Topical Anesthetics: Benzocaine Versus Pliaglis
Anesthesia of Mucous Membrane
Bottom Line
View on ClinicalTrials.gov: NCT01951820 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcome: Primary: Measurement of Pain Associated With Injection, in Millimeters, According to Visual Analog Scale — 38.5; 26.9 mm
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Pliaglis (Drug); Benzocaine (Drug); Articaine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measurement of Pain Associated With Injection, in Millimeters, According to Visual Analog Scale |
38.5; 26.9 | — |
Summary
The efficacy of the topical anesthetics will be determined by how much pain the patient felt (using a Heft-Parker pain analog scale) upon needle penetration.
Eligibility Criteria
Inclusion Criteria
- normal healthy adults 18+ yrs old requiring root canal treatment of maxillary molars
- Patients with healthy mucosal tissues, and who do not have pain on palpation at injection site
- Ability to use and understand a VAS score
- Ability to use and understand a VAS score
- No know allergies to topical anesthetics being used
Exclusion Criteria
- Allergy or other contraindications to topical anesthetics
- Allergy to epinephrine or local anesthetics
- Broken/unhealthy mucosal tissues and pain on palpation at injection site
- Patients needing endodontic therapy on maxillary anterior teeth
- Inability to consent to participate in the study
- Patients who have used analgesics within 6 hours of appointment time
- Pregnant and nursing women
Data sourced from ClinicalTrials.gov (NCT01951820). 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.