Evaluating Commercial Anti-Plaque Products and Oral Rinse
- Conditions
- Dental Plaque
- Interventions
- Registration Number
- NCT01014143
- Lead Sponsor
- Colgate Palmolive
- Brief Summary
Clinical research study to determine the anti-plaque efficacy of commerical dentifrices and an oral rinse.
- Detailed Description
This clinical research study was to train new examiners for short term plaque clinical methodologies.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
- Male or female volunteers at least 18 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.
- 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).
- Two 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 are currently affect salivary function.
- Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
- Allergy to chlorhexidine.
- 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 pre-medication for dental treatment or for any other purpose.
- Presence of an orthodontic appliance that interferes with plaque scoring.
- 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 Fluoride toothpaste Fluoride Negative control Triclosan/Fluoride toothpaste Fluoride, triclosan positive control toothpaste Chlorhexidine Oral Rinse Chlorhexidine digluconate Positive Control mouthrinse
- Primary Outcome Measures
Name Time Method Plaque Index Four days Plaque 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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
New Institutional Service Company
🇺🇸Northfield, New Jersey, United States