Comparison of Two Topical Anesthetics: Benzocaine Versus Pliaglis
Information source: University of Michigan
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anesthesia of Mucous Membrane
Intervention: Pliaglis (Drug); Benzocaine (Drug); Articaine (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Michigan Official(s) and/or principal investigator(s): Brian l Royle, DDS, Principal Investigator, Affiliation: University of Michigan department of Endodontics
Overall contact: Brian L Royle, DDS, Phone: 734-764-1540, Email: brroyle@umich.edu
Summary
This project will be a double blind study comparing the efficacy of two different topical
anesthetics used to reduce the pain associated with insertion of dental needles on the
palatal mucosa. The two topical anesthetics being compared are 20% Benzocaine, and Pliaglis.
In order to complete a number of different dental procedures it is often necessary to
provide local anesthesia of the palate. Intraoral injections into the palatal mucosa are
often uncomfortable and even painful. In an effort to increase patient comfort, a topical
anesthetic is often used prior to the injection. Test subjects undergoing routine endodontic
treatment on maxillary teeth will have a 27- gauge dental needle inserted into the mucosa of
the hard palate as part of the initial step in standard local anesthetic injection. At the
injection site and prior to the needle stick, the mucosa will be topically anesthetized by
using one of the two different test compounds (Benzocaine or Pliaglis). After the injection
patients will be asked to score the level of discomfort associated with the needle stick.
The purpose of the project is to determine if there is a clinical difference in the level of
pain felt upon needle stick, between the two different topical anesthetics.
Clinical Details
Official title: Comparison of Efficacy of Two Topical Anesthetics: Benzocaine Versus Pliaglis for Control of Pain Associated With Dental Needle Insertion in the Palate, A Double Blind Study
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Primary outcome: Measurement of pain associated with injection, in millimeters, according to visual analog scale
Detailed description:
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Brian L Royle, DDS, Phone: 734-764-1540, Email: brroyle@umich.edu
University of Michigan Dental School, Ann Arbor, Michigan 48109, United States; Recruiting brian l royle, dds, Phone: 734-764-1540, Email: brroyle@umich.edu brian l royle, dds, Principal Investigator
Additional Information
Starting date: August 2013
Last updated: September 24, 2013
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