Comparative Efficacy of 20% Benzocaine Versus TAC Alternate Gel
Information source: The University of Texas Health Science Center, Houston
ClinicalTrials.gov processed this data on August 23, 2015
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 pressureoxygen 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
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