Compare the Clinical Efficacy of Prototype Toothpastes.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Colgate Palmolive
- Enrollment
- 103
- Locations
- 1
- Primary Endpoint
- Gingivitis Score
Study Overview
Brief Summary
Evaluate clinical efficacy of a prototype toothpaste on control of dental plaque gingival inflammation
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Male or female volunteers 18-65 years of age
- •Good general health
- •Must sign informed consent form
- •Minimum of 16 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.
- •Dental Selection Criteria: Average full mouth GI score should be in the range of
- •heavy plaque formers should be avoided. Target a full mouth PI
- •(Quigley-Hein) to be in the range of 1.5-3.0
- •If of child bearing potential and on birth control (diaphragm, birth control pills,
- •Birth control implants, IUD (Intrauterine device), condoms)
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
- •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 are 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
- •Use of tobacco products
- •Subjects who must receive dental treatment during the study dates.
- •Current use of Antibiotics for any purpose.
- •History of allergy to common dentifrice ingredients
- •Presence of an orthodontic appliance which interferes with plaque scoring.
- •History of allergy to natural remedies, such as herbal ingredients
- •Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
Arms & Interventions
A
commercially available Fluoride toothpaste
Intervention: Fluoride (Drug)
B
fluoride/triclosan/copolymer toothpaste
Intervention: Triclosan and fluoride (Drug)
C
fluoride/herbal toothpaste
Intervention: Herbal Ingredient and fluoride (Drug)
Outcomes
Primary Outcomes
Gingivitis Score
Time Frame: 6 weeks
Gingivitis score (GI)= Units on a 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. GI scored=sum of GI scores divided by the number of sites (gingival gum line around the tooth)scored.
Dental Plaque
Time Frame: 6 weeks
Quigley Hein Method: 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. Plaque score= sum of all scores divided by the number of sites (teeth) scored.
Bleeding Index (EIBI)
Time Frame: 6 weeks
Eastman Interdental Bleeding Index Scores (EIBI) measures the number of interdental spaces that bleed, divided by number of interdental spaces studied to yield a score with a minimum of O and a maximum of 1 (0=no bleeding \& 1= bleeding) The number of spots between teeth that bleed are divided by number of spots between teeth that are scored and may be expressed as a percent when multiplied by 100.
Secondary Outcomes
No secondary outcomes reported