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Trial record 4 of 43 for:    FLUORIDE ION AND TRICLOSAN

Development of Clinical Method to Triclosan Retention in Plaque Following Brushing

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: NCT00762853
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : September 14, 2010
Last Update Posted : February 17, 2012
Sponsor:
Information provided by:
Colgate Palmolive

Tracking Information
First Submitted Date  ICMJE September 26, 2008
First Posted Date  ICMJE September 30, 2008
Results First Submitted Date  ICMJE August 19, 2010
Results First Posted Date  ICMJE September 14, 2010
Last Update Posted Date February 17, 2012
Study Start Date  ICMJE May 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 16, 2012)
Triclosan Concentration in Dental Plaque [ Time Frame: 12 hours ]
Triclosan is analyzed by gas chromatography (GC) with Atomic Emission Detection (480 nm) and quantitated by determining the ration of the peak height of triclosan to the peak height of an internal standard and relating the result to corresponding ratios of calibration standards.
Original Primary Outcome Measures  ICMJE
 (submitted: September 26, 2008)
Dental plaque [ Time Frame: 16 days ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Development of Clinical Method to Triclosan Retention in Plaque Following Brushing
Official Title  ICMJE Development of Clinical Method to Triclosan Retention in Plaque Following Brushing
Brief Summary The objective is to develop a method to determine active ingredient uptake in oral care products.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Dental Plaque
Intervention  ICMJE
  • Drug: Fluoride
    Brush half mouth once with assigned study treatment
  • Drug: Fluoride and triclosan
    Brush half mouth once with assigned study treatment
    Other Name: Colgate Total toothpaste
Study Arms  ICMJE
  • Placebo Comparator: A
    fluoride toothpaste from Thailand
    Intervention: Drug: Fluoride
  • Active Comparator: B
    fluoride/triclosan/copolymer toothpaste
    Intervention: Drug: Fluoride and triclosan
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 Completed
Actual Enrollment  ICMJE
 (submitted: September 26, 2008)
20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female volunteer 18 - 65 years of age (inclusive).
  • Good general health with a minimum of twenty (20) natural, uncrowned teeth (excluding third molars)
  • Able and willing to sign the informed consent form.
  • Plaque score of at least 1.5 on the modified Quigley-Hein plaque index.
  • No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study

Exclusion Criteria:

  • Medical condition which requires pre-medication prior to dental procedures/visits
  • Medical condition which precludes not eating/drinking for 2 hours
  • Advanced periodontal disease (gum disease)
  • 5 or more decayed, untreated dental sites (cavities)
  • Diseases of the soft or hard oral tissues
  • Orthodontic appliances
  • Abnormal salivary function
  • Use of drugs that can affect salivary flow
  • Use of antibiotics one (1) month prior to or during this study
  • Use of any over the counter medications other than analgesics (i.e. aspirin, ibuprofen, acetaminophen, naproxyn, etc)
  • Pregnant or breastfeeding.
  • Participation in another clinical study in the month preceding this study
  • Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (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 Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00762853
Other Study ID Numbers  ICMJE CRO-2008-PLA-16-RR
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party William DeVizio/VP - Clinical Research, Colgate Palmolive
Study Sponsor  ICMJE Colgate Palmolive
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Terdphong Triantana, DDS
PRS Account Colgate Palmolive
Verification Date August 2010

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