Training and Calibration of Dental Examiners

This study has been completed.
Sponsor:
Information provided by:
Colgate Palmolive
ClinicalTrials.gov Identifier:
NCT00765167
First received: September 23, 2008
Last updated: October 2, 2008
Last verified: October 2008

September 23, 2008
October 2, 2008
November 2007
December 2007   (final data collection date for primary outcome measure)
Dental plaque [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00765167 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Training and Calibration of Dental Examiners
Training and Calibration of Dental Examiners

Training and calibration of dental examiners

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Dental Plaque
  • Drug: Fluoride
    Brush half mouth twice daily for four days
  • Drug: Triclosan
    Brush half mouth daily for four days
  • Drug: Chlorhexidine gluconate
    Mouth rinsing with 15 ml for 30 seconds twice a day for four days
  • Drug: Fluoride
    Brush half mouth daily for four days
  • Placebo Comparator: A
    Intervention: Drug: Fluoride
  • Active Comparator: B
    Interventions:
    • Drug: Triclosan
    • Drug: Fluoride
  • Active Comparator: C
    Intervention: Drug: Chlorhexidine gluconate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
December 2007
December 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female volunteers 18-65 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:

  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 or heavy dental tartar (calculus).
  4. 2 or more decayed untreated dental sites at screening.
  5. Other disease of the hard or soft oral tissues.
  6. Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
  7. Use of medications that can affect salivary flow (e.g. anticholinergics, adrenergics, antihistamines, vasoconstrictors or decongestants).
  8. Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
  9. Pregnant or nursing women.
  10. Participation in any other clinical study within 1 week prior to enrollment into this study.
  11. Allergy to chlorhexidine
  12. Use of tobacco products
  13. Subjects who must receive dental treatment during the study dates.
  14. Current use of Antibiotics for any purpose.
  15. Presence of an orthodontic appliance.
  16. History of allergy to common dentifrice ingredients.
  17. Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00765167
ATO-2007-PLA-01-RR
No
William DeVizio/VP - Clinical Research, Colgate Palmolive
Colgate Palmolive
Not Provided
Principal Investigator: Michael Deasy, DDS
Colgate Palmolive
October 2008

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