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Comparative Efficacy of 20% Benzocaine Versus TAC Alternate Gel

Information source: The University of Texas Health Science Center, Houston
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dental Pain; Postoperative Pain

Intervention: benzocaine (Drug); TAC alternate gel (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: The University of Texas Health Science Center, Houston

Official(s) and/or principal investigator(s):
Femme L Ambrosio, DDS, Principal Investigator, Affiliation: UT Health Science Center Houston
Arthur H Jeske, DDS, PhD, Study Chair, Affiliation: UT Health Science Center Houston

Overall contact:
Femme L Ambrosio, DDS, Phone: 858 603-6345, Email: femme.l.ambrosio@uth.tmc.edu

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).

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Primary outcome: visual analogue scale score

Secondary outcome:

blood pressure

oxygen saturation

heart rate

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Femme L Ambrosio, DDS, Phone: 858 603-6345, Email: femme.l.ambrosio@uth.tmc.edu

UT Pediatric Dentistry Clinic Houston Medical Center, 6655 Travis Suite 460, Texas 77030, United States; Recruiting
Femme L Ambrosio, DDS, Phone: 858-603-6345, Email: femme.l.ambrosio@uth.tmc.edu
Arthur H Jeske, DDS PhD, Phone: 7135004506, Email: arthur.h.jeske@uth.tmc.edu
Robert Tate, DDS MS, Sub-Investigator
Additional Information

Starting date: January 2009
Last updated: February 18, 2009

Page last updated: February 07, 2013

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