Comparative Efficacy of 20% Benzocaine Versus TAC Alternate Gel

February 18, 2009 updated by: The University of Texas Health Science Center, Houston

Comparative Efficacy of 20% Benzocaine Versus TAC Alternate Gel for Control of Pain of Dental Needle Insertion in the Palate

The project is a study comparing the effectiveness of two topical anesthetics for control of pain associated with dental needle insertion in the palatal mucosa. A standard dental topical anesthetic (20% benzocaine) will serve as an "active" control and will be compared to a combination topical anesthetic, consisting of 20% lidocaine, 4% tetracaine and 2% phenylephrine (TAC Alternate Gel, Compounding Arts Pharmacy, Lafayette, LA).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • 6655 Travis Suite 460, Texas, United States, 77030
        • Recruiting
        • UT Pediatric Dentistry Clinic Houston Medical Center
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Robert Tate, DDS MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Volunteers 18 years or older
  2. Ability to consent to participate in the research
  3. Ability to communicate a VAS score
  4. Generally healthy, ASA I and ASA II
  5. No known drug allergies
  6. Ability to tolerate pulse oximeter and blood pressure cuff without psychological, or physiological consequence

Exclusion Criteria:

  1. Allergy or other contraindications to the topical anesthetics
  2. Inability to consent to participation in the study
  3. Use of analgesics prior to the procedure
  4. Vulnerable populations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Benzocaine
serves as "active" control
Drug: benzocaine
20% benzocaine., topical placement onto site, minimal amount, for 1 minute
Other Names:
  • Hurricaine
Experimental: TAC
serves as comparator
Drug: TAC alternate gel
use 1 pump, place topically onto site, leave for 1-3 minutes
Other Names:
  • 20% TAC alternate gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
visual analogue scale score
Time Frame: pre-op, insertion, every minute post-op for 10 minutes
pre-op, insertion, every minute post-op for 10 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
blood pressure
Time Frame: three times pre-op, insertion, ten times post-op
three times pre-op, insertion, ten times post-op
oxygen saturation
Time Frame: three times pre-op, insertion, ten times post-op
three times pre-op, insertion, ten times post-op
heart rate
Time Frame: three times pre-op, insertion, ten times post-op
three times pre-op, insertion, ten times post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: Femme L Ambrosio, DDS, UT Health Science Center Houston
  • Study Chair: Arthur H Jeske, DDS, PhD, UT Health Science Center Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Anticipated)

March 1, 2009

Study Completion (Anticipated)

May 1, 2009

Study Registration Dates

First Submitted

February 18, 2009

First Submitted That Met QC Criteria

February 18, 2009

First Posted (Estimate)

February 19, 2009

Study Record Updates

Last Update Posted (Estimate)

February 19, 2009

Last Update Submitted That Met QC Criteria

February 18, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-DB-08-0484

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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