Recruiting

Benzocaine vs. TAC

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT00846690

Conditions

Dental Pain

Postoperative Pain

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

benzocaine

TAC alternate gel

Study Details

Brief summary:

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).

Conditions

Dental Pain

Postoperative Pain

Study ID

NCT00846690

Start date

Jan, 2009

Status verified date

Feb, 2009

Completion date

May, 2009

Anticipated

Primary completion date

Mar, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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 Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Benzocaine

serves as "active" control

experimental: TAC

serves as comparator

Interventions

benzocaine

20% benzocaine., topical placement onto site, minimal amount, for 1 minute

TAC alternate gel

use 1 pump, place topically onto site, leave for 1-3 minutes

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Femme L Ambrosio, DDS

858 603-6345femme.l.ambrosio@uth.tmc.edu

Arthur H Jeske, DDS, PhD

713 500 4506arthur.h.jeske@uth.tmc.edu

Locations

UT Pediatric Dentistry Clinic Houston Medical Center

Recruiting

6655 Travis Suite 460, Texas, United States, 77030

Contacts

Femme L Ambrosio, DDS

858-603-6345femme.l.ambrosio@uth.tmc.edu

Arthur H Jeske, DDS PhD

7135004506arthur.h.jeske@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Feb 19, 2009

Last verified

Feb, 2009

Keywords

  • topical anesthetics
  • topical anesthesia
  • 20% benzocaine
  • TAC alternate gel
  • combination topical anesthetics
  • dental anesthesia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2009-02-19.