Train New Examiners Via Modified Gingival Margin Plaque
Phase 3
Completed
- Conditions
- Dental Plaque
- Interventions
- Drug: Triclosan/FluorideDrug: Fluoride
- Registration Number
- NCT00758563
- Lead Sponsor
- Colgate Palmolive
- Brief Summary
The purpose of this study is to train new examiners while testing two commercial products using our standard one-day brushing study regimen by measuring gingival margin plaque index.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
- Male or female volunteers 18-65 years of age
- Good general health
- Must sign informed consent form
- Must discontinue oral hygiene for 24-hrs.after initial appointment.
- 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
- 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).
- 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 affect salivary flow
- 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.
- History of allergy to common dentifrice ingredients.
- Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description B Triclosan/Fluoride - A Fluoride -
- Primary Outcome Measures
Name Time Method Mean Gingival Plaque Units 1 day Scale 0 to 100% of tooth gingival margin covered by plaque. (0=no plaque, 100%=100% of the tooth's gingival margin is covered in plaque).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Northampton Community College
🇺🇸Bethlehem, Pennsylvania, United States