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Comparative Efficacy of 20% Benzocaine Versus TAC Alternate Gel

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00846690
Recruitment Status : Unknown
Verified February 2009 by The University of Texas Health Science Center, Houston.
Recruitment status was:  Recruiting
First Posted : February 19, 2009
Last Update Posted : February 19, 2009
Sponsor:
Information provided by:
The University of Texas Health Science Center, Houston

Tracking Information
First Submitted Date  ICMJE February 18, 2009
First Posted Date  ICMJE February 19, 2009
Last Update Posted Date February 19, 2009
Study Start Date  ICMJE January 2009
Estimated Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 18, 2009)		 visual analogue scale score [ Time Frame: pre-op, insertion, every minute post-op for 10 minutes ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2009)
  • blood pressure [ Time Frame: three times pre-op, insertion, ten times post-op ]
  • oxygen saturation [ Time Frame: three times pre-op, insertion, ten times post-op ]
  • heart rate [ Time Frame: three times pre-op, insertion, ten times post-op ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparative Efficacy of 20% Benzocaine Versus TAC Alternate Gel
Official Title  ICMJE Comparative Efficacy of 20% Benzocaine Versus TAC Alternate Gel for Control of Pain of Dental Needle Insertion in the Palate
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE
  • Dental Pain
  • Postoperative Pain
Intervention  ICMJE
  • Drug: benzocaine
    20% benzocaine., topical placement onto site, minimal amount, for 1 minute
    Other Name: Hurricaine
  • Drug: TAC alternate gel
    use 1 pump, place topically onto site, leave for 1-3 minutes
    Other Name: 20% TAC alternate gel
Study Arms  ICMJE
  • Active Comparator: Benzocaine
    serves as "active" control
    Intervention: Drug: benzocaine
  • Experimental: TAC
    serves as comparator
    Intervention: Drug: TAC alternate gel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 18, 2009)		 20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2009
Estimated Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00846690
Other Study ID Numbers  ICMJE HSC-DB-08-0484
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Femme Ambrosio, University of Texas Health Science Center Houston
Original Responsible Party Same as current
Current Study Sponsor  ICMJE The University of Texas Health Science Center, Houston
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Femme L Ambrosio, DDS UT Health Science Center Houston
Study Chair: Arthur H Jeske, DDS, PhD UT Health Science Center Houston
PRS Account The University of Texas Health Science Center, Houston
Verification Date February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP