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Trial record 22 of 43 for:    FLUORIDE ION AND TRICLOSAN

Evaluating Commercial Anti-Plaque Products and Oral Rinse

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: NCT01014143
Recruitment Status : Completed
First Posted : November 16, 2009
Results First Posted : November 16, 2009
Last Update Posted : June 14, 2011
Sponsor:
Information provided by:
Colgate Palmolive

Tracking Information
First Submitted Date  ICMJE September 26, 2008
First Posted Date  ICMJE November 16, 2009
Results First Submitted Date  ICMJE September 26, 2008
Results First Posted Date  ICMJE November 16, 2009
Last Update Posted Date June 14, 2011
Study Start Date  ICMJE August 2007
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2011)
Plaque Index [ Time Frame: Four days ]
Plaque scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque,3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)
Original Primary Outcome Measures  ICMJE
 (submitted: October 5, 2009)
Plaque Index [ Time Frame: Four days ]
Change History Complete list of historical versions of study NCT01014143 on ClinicalTrials.gov Archive Site
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 Evaluating Commercial Anti-Plaque Products and Oral Rinse
Official Title  ICMJE Evaluating Commercial Anti-Plaque Products and Oral Rinse
Brief Summary Clinical research study to determine the anti-plaque efficacy of commerical dentifrices and an oral rinse.
Detailed Description This clinical research study was to train new examiners for short term plaque clinical methodologies.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Dental Plaque
Intervention  ICMJE
  • Drug: Fluoride
    Half mouth toothbrushing twice a day for four days.
    Other Name: fluoride toothpaste
  • Drug: Chlorhexidine digluconate
    Mouth rinsing with 15 ml for 30 seconds twice a day for four days.
    Other Name: Periogard oral rinse
  • Drug: Fluoride, triclosan
    Half mouth Brushing twice daily
    Other Name: Total toothpaste
Study Arms  ICMJE
  • Placebo Comparator: Fluoride toothpaste
    Negative control
    Intervention: Drug: Fluoride
  • Active Comparator: Triclosan/Fluoride toothpaste
    positive control toothpaste
    Intervention: Drug: Fluoride, triclosan
  • Active Comparator: Chlorhexidine Oral Rinse
    Positive Control mouthrinse
    Intervention: Drug: Chlorhexidine digluconate
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: June 10, 2011)
26
Original Actual Enrollment  ICMJE
 (submitted: October 5, 2009)
28
Actual Study Completion Date  ICMJE September 2007
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female volunteers at least 18 years of age.
  • Good general health.
  • Must sign informed consent form.
  • Minimum of 20 natural uncrowned teeth (excluding third molars) must be present.
  • No 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:

  • Subjects unable or unwilling to sign the informed consent form.
  • Medical condition which requires pre-medication prior to dental visits/procedures.
  • Moderate or advanced periodontal disease or heavy dental tartar (calculus).
  • Two or more decayed untreated dental sites at screening.
  • Other disease of the hard or soft oral tissues.
  • Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
  • Use of medications that are currently affect salivary function.
  • Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
  • Allergy to chlorhexidine.
  • Pregnant or nursing women.
  • Participation in any other clinical study within 1 week prior to enrollment into this study.
  • Use of tobacco products.
  • Subjects who must receive dental treatment during the study dates.
  • Current use of Antibiotics for pre-medication for dental treatment or for any other purpose.
  • Presence of an orthodontic appliance that interferes with plaque scoring.
  • History of allergy to common dentifrice ingredients.
  • Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 23 Years to 81 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01014143
Other Study ID Numbers  ICMJE CRO-2007-PLA-15-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: Matthew Cronin, DDS
PRS Account Colgate Palmolive
Verification Date June 2011

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