Investigation of Dental Plaque and Gingival Index
Phase 3
Completed
- Conditions
- Dental Plaque
- Interventions
- Drug: Triclosan/Fluoride/Copolymer
- Registration Number
- NCT00759031
- Lead Sponsor
- Colgate Palmolive
- Brief Summary
Investigation of inhibitory effect of prototype toothpaste on dental plaque formation via modified gingival margin plaque index method.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
Inclusion Criteria
- Be aged 18 to 65 years inclusive
- Have a minimum of 20 natural uncrowned teeth (excluding 3rd molars) present
- Give written informed consent
- Be in good general health
- Must discontinue oral hygiene for 24-hrs.after initial appointment.
- 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
Exclusion Criteria
- Medical condition which requires pre-medication prior to dental visits/procedures
- Advanced periodontal disease
- 5 or more decayed, untreated dental sites
- Diseases of the soft or hard oral tissues
- Orthodontic appliances
- Abnormal salivary function
- Use of drugs that can currently affect salivary flow
- Use of antibiotics one (1) month prior to or during this study
- Use of any over the counter medications other than analgesics (i.e. aspirin, ibuprofen, acetaminophen, naproxyn)
- Pregnant or breastfeeding.
- Participation in another clinical study in the month preceding this study
- Allergic 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/NaF/CoPolymer toothpaste Triclosan/Fluoride/Copolymer - A - Marketed fluoride toothpaste Sodium Monofluorophosphate -
- Primary Outcome Measures
Name Time Method Gingival Margin Plaque Index 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). The lower the score less dental plaque is present along the gum line and therefore the better the performance of the study treatment.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Boston University School of Dental Medicine
🇺🇸New York, New York, United States