Comparative Efficacy of 20% Benzocaine Versus TAC Alternate Gel

Overview

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).

Full Title of Study: “Comparative Efficacy of 20% Benzocaine Versus TAC Alternate Gel for Control of Pain of Dental Needle Insertion in the Palate”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: March 2009

Interventions

  • Drug: benzocaine
    • 20% benzocaine., topical placement onto site, minimal amount, for 1 minute
  • Drug: TAC alternate gel
    • use 1 pump, place topically onto site, leave for 1-3 minutes

Arms, Groups and Cohorts

  • Active Comparator: Benzocaine
    • serves as “active” control
  • Experimental: TAC
    • serves as comparator

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • The University of Texas Health Science Center, Houston
  • Provider of Information About this Clinical Study
    • Femme Ambrosio, University of Texas Health Science Center Houston
  • Overall Official(s)
    • Femme L Ambrosio, DDS, Principal Investigator, UT Health Science Center Houston
    • Arthur H Jeske, DDS, PhD, Study Chair, UT Health Science Center Houston
  • Overall Contact(s)
    • Femme L Ambrosio, DDS, 858 603-6345, femme.l.ambrosio@uth.tmc.edu

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