Clinical trial

Evaluation of the Anticaries Efficacy of Various Dentifrice Formulations Using an In-situ Model

Name
2022085
Description
The primary objective is to compare the remineralization and demineralization inhibition potential of early subsurface carious lesions in enamel in situ after rinsing with six different aqueous slurries of toothpaste formulations.
Trial arms
Trial start
2023-07-31
Estimated PCD
2023-12-11
Trial end
2023-12-11
Status
Completed
Treatment
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.
Arms:
Oral-B 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.
Arms:
Colgate 1450 ppm Fluoride (1.16% sodium monofluorophosphate)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.
Arms:
Toms of Maine 0 ppm Fluoride 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.
Arms:
Colgate 1450 ppm Fluoride (1.1% 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.
Arms:
1500 ppm MFP/CaCO3 1.16% sodium monofluorophosphate) 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.
Arms:
1100 ppm (0.454% Stannous fluoride) Dentifrice
Size
12
Primary endpoint
Mineral Density
14 days
Scanning Electron Microscopy (SEM)
14 days
Eligibility criteria
Inclusion Criteria: * Be 18-75 years of age. * 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: -
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 12, 'type': 'ACTUAL'}}
Updated at
2024-02-29

1 organization

14 products

1 indication

Indication
Dental Caries
Organization
Procter and Gamble