NCT00758290
Completed
Phase 3
Clinical Study to Evaluate Dental Plaque
ConditionsGingival Diseases
Overview
- Phase
- Phase 3
- Intervention
- Triclosan/Fluoride
- Conditions
- Gingival Diseases
- Sponsor
- Colgate Palmolive
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Dental Plaque Index
- Status
- Completed
- Last Updated
- 17 years ago
Overview
Brief Summary
Clinical research study to determine anti-plaque efficacy of a prototype toothpastes for a 3 week brushing regiment.
Investigators
Eligibility Criteria
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
Arms & Interventions
A
Intervention: Triclosan/Fluoride
B
Intervention: Fluoride/triclosan
Outcomes
Primary Outcomes
Dental Plaque Index
Time Frame: 4 Day
Plaque units measured on a scale between 0 to 5. No plaque=0;5=2/3 of tooth covered in plaque
Study Sites (1)
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