Back to resultsComparative Efficacy of 20% Benzocaine Versus TAC Alternate Gel
Primary Purpose
Dental Pain, Postoperative Pain
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
benzocaine
TAC alternate gel
Sponsored by
About this trial
This is an interventional treatment trial for Dental Pain focused on measuring topical anesthetics, topical anesthesia, 20% benzocaine, TAC alternate gel, combination topical anesthetics, dental anesthesia
Eligibility Criteria
Inclusion Criteria:
- Volunteers 18 years or older
- Ability to consent to participate in the research
- Ability to communicate a VAS score
- Generally healthy, ASA I and ASA II
- No known drug allergies
- Ability to tolerate pulse oximeter and blood pressure cuff without psychological, or physiological consequence
Exclusion Criteria:
- Allergy or other contraindications to the topical anesthetics
- Inability to consent to participation in the study
- Use of analgesics prior to the procedure
- Vulnerable populations
Sites / Locations
- UT Pediatric Dentistry Clinic Houston Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Benzocaine
TAC
Arm Description
serves as "active" control
serves as comparator
Outcomes
Primary Outcome Measures
visual analogue scale score
Secondary Outcome Measures
blood pressure
oxygen saturation
heart rate
Full Information
NCT ID
NCT00846690
First Posted
February 18, 2009
Last Updated
February 18, 2009
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT00846690
Brief Title
Comparative Efficacy of 20% Benzocaine Versus TAC Alternate Gel
Official Title
Comparative Efficacy of 20% Benzocaine Versus TAC Alternate Gel for Control of Pain of Dental Needle Insertion in the Palate
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
March 2009 (Anticipated)
Study Completion Date
May 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Pain, Postoperative Pain
Keywords
topical anesthetics, topical anesthesia, 20% benzocaine, TAC alternate gel, combination topical anesthetics, dental anesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Benzocaine
Arm Type
Active Comparator
Arm Description
serves as "active" control
Arm Title
TAC
Arm Type
Experimental
Arm Description
serves as comparator
Intervention Type
Drug
Intervention Name(s)
benzocaine
Other Intervention Name(s)
Hurricaine
Intervention Description
20% benzocaine., topical placement onto site, minimal amount, for 1 minute
Intervention Type
Drug
Intervention Name(s)
TAC alternate gel
Other Intervention Name(s)
20% TAC alternate gel
Intervention Description
use 1 pump, place topically onto site, leave for 1-3 minutes
Primary Outcome Measure Information:
Title
visual analogue scale score
Time Frame
pre-op, insertion, every minute post-op for 10 minutes
Secondary Outcome Measure Information:
Title
blood pressure
Time Frame
three times pre-op, insertion, ten times post-op
Title
oxygen saturation
Time Frame
three times pre-op, insertion, ten times post-op
Title
heart rate
Time Frame
three times pre-op, insertion, ten times post-op
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Volunteers 18 years or older
Ability to consent to participate in the research
Ability to communicate a VAS score
Generally healthy, ASA I and ASA II
No known drug allergies
Ability to tolerate pulse oximeter and blood pressure cuff without psychological, or physiological consequence
Exclusion Criteria:
Allergy or other contraindications to the topical anesthetics
Inability to consent to participation in the study
Use of analgesics prior to the procedure
Vulnerable populations
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Femme L Ambrosio, DDS
Phone
858 603-6345
Email
femme.l.ambrosio@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Arthur H Jeske, DDS, PhD
Phone
713 500 4506
Email
arthur.h.jeske@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Femme L Ambrosio, DDS
Organizational Affiliation
UT Health Science Center Houston
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arthur H Jeske, DDS, PhD
Organizational Affiliation
UT Health Science Center Houston
Official's Role
Study Chair
Facility Information:
Facility Name
UT Pediatric Dentistry Clinic Houston Medical Center
City
6655 Travis Suite 460
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Femme L Ambrosio, DDS
Phone
858-603-6345
Email
femme.l.ambrosio@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Arthur H Jeske, DDS PhD
Phone
7135004506
Email
arthur.h.jeske@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Robert Tate, DDS MS
12. IPD Sharing Statement
Learn more about this trial
Comparative Efficacy of 20% Benzocaine Versus TAC Alternate Gel
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