Evaluation of the Fluoride Dose Response Using In Situ Caries Model
NCT ID: NCT04763044
Last Updated: 2022-07-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
15 participants
INTERVENTIONAL
2021-03-01
2021-07-21
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
OTHER
DOUBLE
Study Groups
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Period 1
0 ppm F (placebo, negative control), 250 ppm F as MFP (dose-response control), 1100 ppm F as MFP (reference), 2800 ppm F as MFP (dose-response control)
0 ppm F
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
250 ppm F as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
1100 ppm as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
2800 ppm F as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
Period 2
0 ppm F (placebo, negative control), 250 ppm F as MFP (dose-response control), 1100 ppm F as MFP (reference), 2800 ppm F as MFP (dose-response control)
0 ppm F
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
250 ppm F as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
1100 ppm as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
2800 ppm F as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
Period 3
0 ppm F (placebo, negative control), 250 ppm F as MFP (dose-response control), 1100 ppm F as MFP (reference), 2800 ppm F as MFP (dose-response control)
0 ppm F
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
250 ppm F as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
1100 ppm as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
2800 ppm F as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
Period 4
0 ppm F (placebo, negative control), 250 ppm F as MFP (dose-response control), 1100 ppm F as MFP (reference), 2800 ppm F as MFP (dose-response control)
0 ppm F
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
250 ppm F as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
1100 ppm as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
2800 ppm F as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
Period 5
1100 ppm SnF2 toothpaste only
1100 ppm SnF2
Each subject will be assigned to this treatment during the fifth period for this crossover study.
Interventions
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0 ppm F
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
250 ppm F as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
1100 ppm as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
2800 ppm F as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
1100 ppm SnF2
Each subject will be assigned to this treatment during the fifth period for this crossover study.
Eligibility Criteria
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Inclusion Criteria
* Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
* Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial;
* Be wearing a removable mandibular partial denture with sufficient room in one posterior buccal flange area to accommodate two 4 mm round enamel specimens and room on the same side to accommodate two 4 mm round specimens in the buccal surface of two posterior denture teeth;
* Be willing and capable of wearing their removable partial denture 24 hours a day for four (4), three-week treatment periods;
* Be willing to allow study personnel to drill specimen sites (as described in #iv) in their mandibular partial denture;
* Be in good medical and dental health with no active caries or periodontal disease (NOTE: subjects presenting at screening with caries may continue in the study if their carious lesions are restored prior to beginning treatment 1);
* Have a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate ≥ 0.2 mL/min; gum base stimulated whole saliva flow rate ≥ 0.8 mL/min).
Exclusion Criteria
* Currently having any medical condition that could be expected to interfere with the subject's safety during the study period;
* Currently taking antibiotics or having taken antibiotics in the two weeks prior to beginning treatment 1;
* Having participated in another clinical study or receipt of an investigational drug within 30 days of beginning treatment 1; or
* Taking fluoride supplements, required to use a fluoride mouth rinse, or have received a professional fluoride treatment in the two weeks preceding specimen placement;
* Currently taking or have ever taken bisphosphonate drugs (e.g., Fosamax, Actonel and Boniva) for the treatment of osteoporosis.
18 Years
85 Years
ALL
Yes
Sponsors
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Procter and Gamble
INDUSTRY
Responsible Party
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Locations
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Oral Health Research Institute
Indianapolis, Indiana, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2020154
Identifier Type: -
Identifier Source: org_study_id
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