Evaluation of the Anticaries Efficacy of Various Dentifrice Formulations Using an In-situ Model
| Registry | NCT06140758 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, crossover, masking: triple, treatment |
| Enrollment | 12 (Actual) |
| Sponsor | Procter and Gamble (Industry) |
| Conditions | Caries |
| Interventions | Oral-B 1450 ppm Fluoride (1.16% sodium monofluorophosphate) Dentifrice, Colgate 1450 ppm Fluoride (1.16% sodium monofluorophosphate)Dentifrice, Toms of Maine 0 ppm Fluoride Dentifrice, Colgate 1450 ppm Fluoride (1.1% sodium monofluorophosphate) Dentifrice, 1500 ppm MFP/CaCO3 1.16% sodium monofluorophosphate) Dentifrice, 1100 ppm (0.454% Stannous fluoride) Dentifrice (Drug) |
| Dates | start 2023-07-31, primary completion 2023-12-11, completion 2023-12-11, first posted 2023-11-20, last updated 2024-02-29 |
| Locations | 1 site in Australia |
Related Papers Related Patents Related Grants Related Experts
All trials for Caries All trials of Oral-B 1450 ppm Fluoride (1.16% sodium monofluorophosphate) Dentifrice All trials of Colgate 1450 ppm Fluoride (1.16% sodium monofluorophosphate)Dentifrice
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Oral-B 1450 ppm Fluoride (1.16% sodium monofluorophosphate) Dentifrice | Active comparator | Drug: Oral-B 1450 ppm Fluoride (1.16% sodium monofluorophosphate) Dentifrice | |
| Colgate 1450 ppm Fluoride (1.16% sodium monofluorophosphate)Dentifrice | Active comparator | Drug: Colgate 1450 ppm Fluoride (1.16% sodium monofluorophosphate)Dentifrice | |
| Toms of Maine 0 ppm Fluoride Dentifrice | Sham comparator | Drug: Toms of Maine 0 ppm Fluoride Dentifrice | |
| Colgate 1450 ppm Fluoride (1.1% sodium monofluorophosphate) Dentifrice | Active comparator | Drug: Colgate 1450 ppm Fluoride (1.1% sodium monofluorophosphate) Dentifrice | |
| 1500 ppm MFP/CaCO3 1.16% sodium monofluorophosphate) Dentifrice | Active comparator | Drug: 1500 ppm MFP/CaCO3 1.16% sodium monofluorophosphate) Dentifrice | |
| 1100 ppm (0.454% Stannous fluoride) Dentifrice | Active comparator | Drug: 1100 ppm (0.454% Stannous fluoride) Dentifrice |
Sex: All, ages: 18 Years to 75 Years, accepts healthy volunteers
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: \-
| Facility | City | Country | Status |
|---|---|---|---|
| University of Melbourne | Melbourne | Australia |