Comparative Efficacy of 20% Benzocaine Versus TAC Alternate Gel

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by The University of Texas Health Science Center, Houston.
Recruitment status was  Recruiting
Information provided by:
The University of Texas Health Science Center, Houston Identifier:
First received: February 18, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
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).

Condition Intervention Phase
Dental Pain
Postoperative Pain
Drug: benzocaine
Drug: TAC alternate gel
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Comparative Efficacy of 20% Benzocaine Versus TAC Alternate Gel for Control of Pain of Dental Needle Insertion in the Palate

Resource links provided by NLM:

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • visual analogue scale score [ Time Frame: pre-op, insertion, every minute post-op for 10 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • blood pressure [ Time Frame: three times pre-op, insertion, ten times post-op ] [ Designated as safety issue: Yes ]
  • oxygen saturation [ Time Frame: three times pre-op, insertion, ten times post-op ] [ Designated as safety issue: Yes ]
  • heart rate [ Time Frame: three times pre-op, insertion, ten times post-op ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: January 2009
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Benzocaine
serves as "active" control
Drug: benzocaine
20% benzocaine., topical placement onto site, minimal amount, for 1 minute
Other Name: Hurricaine
Experimental: TAC
serves as comparator
Drug: TAC alternate gel
use 1 pump, place topically onto site, leave for 1-3 minutes
Other Name: 20% TAC alternate gel


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00846690

Contact: Femme L Ambrosio, DDS 858 603-6345
Contact: Arthur H Jeske, DDS, PhD 713 500 4506

United States, Texas
UT Pediatric Dentistry Clinic Houston Medical Center Recruiting
6655 Travis Suite 460, Texas, United States, 77030
Contact: Femme L Ambrosio, DDS    858-603-6345   
Contact: Arthur H Jeske, DDS PhD    7135004506   
Sub-Investigator: Robert Tate, DDS MS         
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Principal Investigator: Femme L Ambrosio, DDS UT Health Science Center Houston
Study Chair: Arthur H Jeske, DDS, PhD UT Health Science Center Houston
  More Information

Responsible Party: Femme Ambrosio, University of Texas Health Science Center Houston Identifier: NCT00846690     History of Changes
Other Study ID Numbers: HSC-DB-08-0484 
Study First Received: February 18, 2009
Last Updated: February 18, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
topical anesthetics
topical anesthesia
20% benzocaine
TAC alternate gel
combination topical anesthetics
dental anesthesia

Additional relevant MeSH terms:
Pain, Postoperative
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Anesthetics, Local
Anti-Arrhythmia Agents
Autonomic Agents
Cardiotonic Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Nasal Decongestants
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Protective Agents
Respiratory System Agents processed this record on May 25, 2016