Clinical Study to Evaluate Dental Plaque

This study has been completed.
Sponsor:
Information provided by:
Colgate Palmolive
ClinicalTrials.gov Identifier:
NCT00758290
First received: September 23, 2008
Last updated: November 20, 2008
Last verified: November 2008

September 23, 2008
November 20, 2008
May 2008
July 2008   (final data collection date for primary outcome measure)
Dental Plaque Index [ Time Frame: 4 Day ] [ Designated as safety issue: No ]
Mean dental plaque scores [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00758290 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Clinical Study to Evaluate Dental Plaque
Clinical Study to Evaluate Dental Plaque

Clinical research study to determine anti-plaque efficacy of a prototype toothpastes for a 3 week brushing regiment.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Gingival Diseases
  • Drug: Triclosan/Fluoride
    Brush twice daily for 3 weeks
  • Drug: Fluoride/triclosan
    Brush daily for 3 weeks
  • Active Comparator: A
    Intervention: Drug: Triclosan/Fluoride
  • Experimental: B
    Intervention: Drug: Fluoride/triclosan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
July 2008
July 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female volunteers at least 20 - 51 years of age
  • Good general health
  • Must sign informed consent form
  • Minimum of 15 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)
  • 5 or more decayed untreated dental sites at screening (cavities)
  • 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 affecting salivary function
  • 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 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 any purpose
  • Presence of an orthodontic appliance which interferes with plaque scoring
  • History of allergy to common toothpaste ingredients
  • History of allergy to arginine (amino acid)
  • Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
Both
20 Years to 51 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00758290
CRO-2008-PLA-13-RR
No
William DeVizio/VP- Clinical Research, Colgate Palmolive
Colgate Palmolive
Not Provided
Principal Investigator: Patricia Corby, DDS
Colgate Palmolive
November 2008

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