Evaluation of the Anticaries Efficacy of Dentifrice Formulations Using an In-situ Model
NCT ID: NCT06140758
Last Updated: 2024-02-29
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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COMPLETED
NA
12 participants
INTERVENTIONAL
2023-07-31
2023-12-11
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
TRIPLE
Study Groups
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Oral-B 1450 ppm Fluoride (1.16% sodium monofluorophosphate) Dentifrice
Oral-B 1450 ppm Fluoride (1.16% sodium monofluorophosphate) Dentifrice
Each subject will use this product during one of the six treatment periods in the crossover study design.
Colgate 1450 ppm Fluoride (1.16% sodium monofluorophosphate)Dentifrice
Colgate 1450 ppm Fluoride (1.16% sodium monofluorophosphate)Dentifrice
Each subject will use this product during one of the six treatment periods in the crossover study design.
Toms of Maine 0 ppm Fluoride Dentifrice
Toms of Maine 0 ppm Fluoride Dentifrice
Each subject will use this product during one of the six treatment periods in the crossover study design.
Colgate 1450 ppm Fluoride (1.1% sodium monofluorophosphate) Dentifrice
Colgate 1450 ppm Fluoride (1.1% sodium monofluorophosphate) Dentifrice
Each subject will use this product during one of the six treatment periods in the crossover study design.
1500 ppm MFP/CaCO3 1.16% sodium monofluorophosphate) Dentifrice
1500 ppm MFP/CaCO3 1.16% sodium monofluorophosphate) Dentifrice
Each subject will use this product during one of the six treatment periods in the crossover study design.
1100 ppm (0.454% Stannous fluoride) Dentifrice
1100 ppm (0.454% Stannous fluoride) Dentifrice
Each subject will use this product during one of the six treatment periods in the crossover study design.
Interventions
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Oral-B 1450 ppm Fluoride (1.16% sodium monofluorophosphate) Dentifrice
Each subject will use this product during one of the six treatment periods in the crossover study design.
Colgate 1450 ppm Fluoride (1.16% sodium monofluorophosphate)Dentifrice
Each subject will use this product during one of the six treatment periods in the crossover study design.
Toms of Maine 0 ppm Fluoride Dentifrice
Each subject will use this product during one of the six treatment periods in the crossover study design.
Colgate 1450 ppm Fluoride (1.1% sodium monofluorophosphate) Dentifrice
Each subject will use this product during one of the six treatment periods in the crossover study design.
1500 ppm MFP/CaCO3 1.16% sodium monofluorophosphate) Dentifrice
Each subject will use this product during one of the six treatment periods in the crossover study design.
1100 ppm (0.454% Stannous fluoride) Dentifrice
Each subject will use this product during one of the six treatment periods in the crossover study design.
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 good general health based on medical/dental history and oral exam.
* Have no history of adverse or allergic reactions to tin or tin-containing products.
* Agree not to participate in any other oral study for the study duration.
* Have a reasonable functional dentition as determined by the oral examiner and sufficient teeth to support the fabricated dental appliance.
* Be willing to participate in the study, able to follow the study directions, successfully tolerate/perform all study procedures, and willing to return for all specified visits at their appointed time.
* Be willing to refrain from using non-study dentifrice, mouth rinse, chewing gum, and other non-study oral care products during the study.
* Be willing to postpone all elective dental procedures until the study has been completed.
* Be willing to refrain from using calcium chews while using the test products.
* Be willing and able to refrain from wearing a nightguard (occlusal splint) for the entire course of the study (for nightguard wearers only).
* Ability to understand, and ability to read and sign, the informed consent form.
* Have at least 22 natural teeth.
* Have a gum-stimulated whole salivary flow rate ≥ 1.0 ml/minute and unstimulated whole salivary flow rate ≥ 0.2 ml/minute.
Exclusion Criteria
18 Years
75 Years
ALL
Yes
Sponsors
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Procter and Gamble
INDUSTRY
Responsible Party
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Locations
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University of Melbourne
Melbourne, , Australia
Countries
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Other Identifiers
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2022085
Identifier Type: -
Identifier Source: org_study_id
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