Clinical trial NCT01951820: Comparison of Two Topical Anesthetics: Benzocaine Versus Pliaglis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia of Mucous Membrane
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: American Association of Endodontists
First posted: 2013-09-27
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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.

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

Primary outcomes:
measure: Measurement of Pain Associated With Injection, in Millimeters, According to Visual Analog Scale
timeFrame: 2.5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Dental School
state: Michigan
Study officials:
affiliation: University of Michigan department of Endodontics
name: Brian l Royle, DDS
role: PRINCIPAL_INVESTIGATOR
References: