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Trial record 5 of 43 for:    FLUORIDE ION AND TRICLOSAN

Efficacy of Salivary Bacteria and Post Brushing

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ClinicalTrials.gov Identifier: NCT00981825
Recruitment Status : Completed
First Posted : September 22, 2009
Results First Posted : September 22, 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 September 22, 2009
Results First Submitted Date  ICMJE September 26, 2008
Results First Posted Date  ICMJE September 22, 2009
Last Update Posted Date June 14, 2011
Study Start Date  ICMJE October 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2009)
CFU (Colony Forming Units) [ Time Frame: 4 hours ]
Total number of salivary bacterial colony forming units (lower number = less colonies present)
Original Primary Outcome Measures  ICMJE Same as current
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 Efficacy of Salivary Bacteria and Post Brushing
Official Title  ICMJE Efficacy of Salivary Bacteria and Post Brushing
Brief Summary Research study to compare the effects of brushing with two commercially available toothpastes on salivary bacteria after brushing
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Salivary Bacteria Levels
Intervention  ICMJE
  • Drug: Fluoride
    Whole mouth brushing for 7 days
    Other Name: fluoride toothpaste (Colgate Great Regular Flavor toothpaste)
  • Drug: Triclosan/Fluoride
    Brush whole mouth twice daily for 7 days
    Other Name: triclosan/fluoride toothpaste (Colgate Total toothpaste)
Study Arms  ICMJE
  • Placebo Comparator: A
    fluoride toothpaste control
    Intervention: Drug: Fluoride
  • Active Comparator: B
    triclosan/fluoride toothpaste
    Intervention: Drug: Triclosan/Fluoride
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: August 14, 2009)
22
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female volunteers 18-65 years of age
  • Good general health
  • Must sign informed consent form
  • Must discontinue oral hygiene on the mornings of each appointment and between sampling periods.
  • 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:

  • Medical condition which requires pre-medication prior to dental procedures/visits
  • Medical condition which precludes eating/drinking for 12 hrs.
  • History of allergy to common dentifrice ingredients
  • Subjects unable or unwilling to sign the informed consent form.
  • Moderate or advanced periodontal disease.
  • 2 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 can currently affect salivary flow
  • Current use of antibiotics
  • Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
  • Pregnant or nursing women.
  • Participation in any other clinical study within 30 days 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 any purpose.
  • 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 India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00981825
Other Study ID Numbers  ICMJE ER0-2007-SAL-01-GX
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: Neelim Utgikar, 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