Clinical Efficacy of Fluoride Toothpastes Using an In Situ Caries Model
NCT ID: NCT02436473
Last Updated: 2015-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2015-12-31
2016-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Test fluoride toothpaste
Participants will apply 1.5 weighed g (± 0.1 g) of the study toothpaste to a wet toothbrush and brush their natural teeth twice daily for one timed minute. Participants will wear their mandibular partial denture with test specimens while brushing and continuously for 24 hours a day during each of the 4-week treatment periods
Toothpaste containing 1150ppm F
US marketed toothpaste containing 1150ppm of F
Fluoride free (0ppm F) reference control toothpaste
Participants will apply 1.5 weighed g (± 0.1 g) of the study toothpaste to a wet toothbrush and brush their natural teeth twice daily for one timed minute. Participants will wear their mandibular partial denture with test specimens while brushing and continuously for 24 hours a day during each of the 4-week treatment periods.
Toothpaste containing 0ppm F
Experimental toothpaste containing 0ppm F
Low dose fluoride (250ppm F) reference control toothpaste
Participants will apply 1.5 weighed g (± 0.1 g) of the study toothpaste to a wet toothbrush and brush their natural teeth twice daily for one timed minute. Participants will wear their mandibular partial denture with test specimens while brushing and continuously for 24 hours a day during each of the 4-week treatment periods.
Toothpaste containing 250ppm F
Experimental toothpaste containing 250ppm F
Fluoride (1150ppm F) reference control toothpaste
Participants will apply 1.5 weighed g (± 0.1 g) of the study toothpaste to a wet toothbrush and brush their natural teeth twice daily for one timed minute. Participants will wear their mandibular partial denture with test specimens while brushing and continuously for 24 hours a day during each of the 4-week treatment periods.
Toothpaste containing 1150ppm F
Experimental toothpaste containing 1150ppm F
Interventions
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Toothpaste containing 1150ppm F
US marketed toothpaste containing 1150ppm of F
Toothpaste containing 0ppm F
Experimental toothpaste containing 0ppm F
Toothpaste containing 250ppm F
Experimental toothpaste containing 250ppm F
Toothpaste containing 1150ppm F
Experimental toothpaste containing 1150ppm F
Eligibility Criteria
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Inclusion Criteria
2. Aged 18 to 85 years.
3. Understands and is willing, able and likely to comply with all study procedures and restrictions.
4. Has good general health (in the opinion of the investigator or medically qualified designee).
5. Currently living in the Indianapolis, Indiana area.
6. Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accommodate two enamel specimens.
7. Have no current active caries or periodontal disease and all restorations in a good state of repair.
8. Have a salivary flow rate in the range of normal values.
Exclusion Criteria
2. Known or suspected intolerance or hypersensitivity to the study materials or their stated ingredients.
3. Currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit.
4. Unable to measure product weights accurately using the assigned study scale as determined by the study staff as demonstrated.
5. Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
6. Have received a professional fluoride treatment within 14 days of randomization to the first treatment.
7. Recent history (within the last year) of alcohol or other substance abuse.
18 Years
85 Years
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Other Identifiers
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203161
Identifier Type: -
Identifier Source: org_study_id
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