Compare the Clinical Efficacy of Prototype Toothpastes
Overview
- Phase
- Phase 3
- Intervention
- Fluoride
- Conditions
- Dental Plaque
- Sponsor
- Colgate Palmolive
- Enrollment
- 98
- Locations
- 1
- Primary Endpoint
- Plaque Index
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
Clinical study to compare the clinical efficacy of toothpastes on dental plaque and gingival inflammation.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female volunteers 18-65 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.
Exclusion Criteria
- •Subject 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.
- •5 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 currently affect salivary flow.
- •Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #
- •Pregnant or nursing women.
- •Participation in any other clinical study within 1 week prior to enrollment into this study.
Arms & Interventions
Fluoride control -A
Winterfresh Gel
Intervention: Fluoride
Triclosan/Fluoride - B
Positive control (Total toothpaste)
Intervention: Triclosan, fluoride
Triclosan/fluoride/metal salt- C
test toothpaste
Intervention: Metal salt
Outcomes
Primary Outcomes
Plaque Index
Time Frame: 6 weeks
Plaque Index score 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)
Gingivitis Index
Time Frame: 6 Weeks
Gingivitis score- scale 0 to 3 (0 = no inflammation,1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)