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Trial record 23 of 43 for:    FLUORIDE ION AND TRICLOSAN

Clinical Study to Evaluate the Treatment of Gingivitis of Two Toothpastes

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: NCT00762515
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : December 14, 2010
Last Update Posted : December 28, 2010
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 December 14, 2010
Last Update Posted Date December 28, 2010
Study Start Date  ICMJE February 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2010)
Control Established Plaque in Adults [ Time Frame: 6 weeks ]
Units on a 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. Total Plaque score=sum of all scores divided by the number of sites (teeth) scored.
Original Primary Outcome Measures  ICMJE
 (submitted: September 26, 2008)
Control Established Plaque in Adults [ Time Frame: 7 weeks ]
Change History Complete list of historical versions of study NCT00762515 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2010)
Control Gingivitis in Adults [ Time Frame: 6 weeks ]
Gingivitis Index (GI) is described as Units on a scale 0 to 3 (0 = no inflammation,1 = Mild inflammation - slight change in color and little change in texture 2 = Moderate inflammation - moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding. GI score = Sum of all scores divided by the number of sites (teeth scored).
Original Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2008)
Control Gingivitis in Adults [ Time Frame: 7 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Study to Evaluate the Treatment of Gingivitis of Two Toothpastes
Official Title  ICMJE Clinical Study to Evaluate the Treatment of Gingivitis of Two Toothpastes
Brief Summary The objective is to compare two commerical oral products for the treatment of gingivitis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Dental Plaque
Intervention  ICMJE
  • Drug: Fluoride
    Brush teeth two times daily for 6 weeks
  • Drug: Triclosan
    Brush two times daily for 6 weeks
  • Drug: Fluoride
    Brush two times daily for 6 weeks
Study Arms  ICMJE
  • Placebo Comparator: A
    commercially available Fluoride only toothpaste
    Intervention: Drug: Fluoride
  • Active Comparator: B
    Commercially available triclosan/copolymer/fluoride toothpaste
    Interventions:
    • Drug: Triclosan
    • Drug: 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: September 26, 2008)
44
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female volunteers 18-65 years of age
  2. Good general health
  3. Must sign informed consent form
  4. Minimum of 16 natural uncrowned teeth (excluding third molars) must be present.
  5. 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.
  6. Dental Selection Criteria: Gingivitis patients with a minimum of 16 gradable teeth with a minimum of 6 sites with a GI score of ≥ 3. Subjects will be stratified according to gingivitis severity. Average full mouth GI score should be in the range of 2.0 - 2.5. heavy plaque formers should be avoided. Target a full mouth PI (Quigley-Hein) to be in the range of 1.5-3.0

Exclusion Criteria:

  1. Subjects unable or unwilling to sign the informed consent form.
  2. Medical condition which requires pre-medication prior to dental visits/procedures
  3. Moderate or advanced periodontal disease
  4. History of allergy to iodine
  5. History of thyroid disease
  6. History of diabetes
  7. 2 or more decayed untreated dental sites at screening.
  8. Other disease of the hard or soft oral tissues.
  9. Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
  10. Use of medications that are currently affect salivary flow.
  11. Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
  12. Pregnant or nursing women.
  13. Participation in any other clinical study within 1 week prior to enrollment into this study.
  14. Use of tobacco products
  15. Subjects who must receive dental treatment during the study dates.
  16. Current use of Antibiotics for any purpose.
  17. Presence of an orthodontic appliance.
  18. History of allergy to common dentifrice ingredients
  19. Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
  20. Women of childbearing potential and not on birth control (Diaphragm, birth control pills or implants, IUD (Intrauterine device), condoms).
  21. Smoker
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00762515
Other Study ID Numbers  ICMJE CRO-2007-GIN-03-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: Denis Kinane, BDS
PRS Account Colgate Palmolive
Verification Date December 2010

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