Study to Determine the Anti-plaque Efficacy of Commerical Toothpastes and an Oral Rinse
Overview
- Phase
- Phase 3
- Intervention
- Fluoride
- Conditions
- Dental Plaque
- Sponsor
- Colgate Palmolive
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Plaque Index
- Status
- Completed
- Last Updated
- 16 years ago
Overview
Brief Summary
Calibration study to determine the anit-plaque efficacy of commerical toothpastes and an oral rinse
Detailed Description
Training of new examiners and validation of new clinical site to run 4 day short-term plaque studies. All products are commercially available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Be aged 18 to 65 years inclusive
- •Have a minimum of 15 natural uncrowned teeth (excluding 3rd molars) present
- •Give written informed consent
- •Be in good general health
- •No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the dental/medical professional monitoring the study
- •If of childbearing potential and on birth control (Diaphragm, Birth Control Pills, Birth Control Implants, IUD (Intrauterine device), condoms)
Exclusion Criteria
- •Medical condition which requires pre-medication (antibiotics) prior to dental
- •Visits/procedures
- •Allergy to chlorhexidine
- •Advanced periodontal disease (gum disease)
- •5 or more decayed, untreated dental sites (cavities)
- •Diseases of the soft or hard oral tissues (gums or palate)
- •Orthodontic appliances that interfere with plaque rating
- •Abnormal salivary function
- •Use of drugs that can affect currently salivary flow or production
- •Use of antibiotics one (1) month prior to or during this study
Arms & Interventions
Fluoride toothpaste
negative control toothpaste
Intervention: Fluoride
Triclosan/Fluoride toothpaste
positive control toothpaste (Total toothpaste)
Intervention: Triclosan, fluoride
Chlorhexidine Oral Rinse
positive control oral rinse
Intervention: Chlorhexidine Gluconate
Outcomes
Primary Outcomes
Plaque Index
Time Frame: 4 Days
Plaque score is Units on a 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)