Anesthesia of Mucous Membrane Clinical Trial
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
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.
| Status | Recruiting |
| Enrollment | 64 |
| Est. completion date | June 2014 |
| Est. primary completion date | May 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Michigan Dental School | Ann Arbor | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| University of Michigan | American Association of Endodontists |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Measurement of pain associated with injection, in millimeters, according to visual analog scale | The investigation is trying to determine if the compounded topical anesthetic (Pliaglis) is more effective than the active control (benzocaine) in numbing the gums before needle penetration. The effectiveness of the topical anesthetics will be determined by the patient indicating their level of discomfort felt upon needle stick by using a Heft-Parker visual analog pain scale (scale of 0 - 170mm). | 2.5 minutes | No |
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