Last updated: 11/03/2018 22:31:08
Clinical Efficacy of Fluoride Toothpastes Using an In Situ Caries Model
GSK study ID
203161
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Withdrawn
Withdrawn
Trial overview
Official title: Clinical Efficacy of Fluoride Toothpastes Using an In Situ Caries Model
Trial description: The purpose of this study is to evaluate the effect of the test toothpaste containing 1150 parts per million (ppm) of fluoride (F) on the mineral content of demineralized enamel specimens, in an in situ caries model system, by comparing the differences in net remineralization change (ΔM) following use of the test toothpaste with a fluoride free (0 ppm F) reference control toothpaste.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Net remineralization change (ΔM) of demineralised enamel specimens following use of the test toothpaste with a fluoride free reference control toothpaste
Timeframe: 4 weeks
Secondary outcomes:
Net remineralization change (ΔM) of demineralised enamel specimens following use of the test toothpaste with all other treatments
Timeframe: 4 weeks
Changes in enamel lesion depth (ΔL) following use of the test toothpaste with all other treatments
Timeframe: 4 weeks
Net change in surface zone mineral content (ΔSZmax) following use of the toothpaste with all other treatments
Timeframe: 4 weeks
Interventions:
Drug: Toothpaste containing 1150ppm F
Other: Toothpaste containing 0ppm F
Drug: Toothpaste containing 250ppm F
Enrollment:
0
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
dental caries
Product
sodium fluoride
Collaborators
Not applicable
Study date(s)
December 2015 to May 2016
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 85 years
Accepts healthy volunteers
Yes
- 1. Demonstrates understanding of the study.
- 2. Aged 18 to 85 years.
- 1. Pregnant or breast feeding women.
- 2. Known or suspected intolerance or hypersensitivity to the study materials or their stated ingredients.
Inclusion and exclusion criteria
Inclusion criteria:
- 1. Demonstrates understanding of the study. 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:
- 1. Pregnant or breast feeding women. 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.
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Withdrawn
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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