Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Federal University of Alagoas | OTHER |
Not provided
Not provided
Not provided
Not provided
Clinical study to evaluate the anti-cavity effectiveness of three dentrifices using an intra-oral enamel Demineralization and Remineralization In-Situ Model. This is a six-week duration, Phase III, single-center, triple-blind crossover study. Thirty-six healthy adults will be randomly allocated to three groups for the treatment phases, which are interspersed with washout periods.
This Phase III, randomized, triple-blind, crossover study will assess the anti-cavity effectiveness of three different dentrifices. Thirty-six participants, aged 18-70, will use an intra-oral appliance. For six weeks, they will be divided into three treatment groups and instructed to brush twice daily with one of the following: one using a fluoride-free toothpaste with a chalk base and herbal ingredients, another using a fluoride toothpaste containing 1000 ppm MFP and 1.5% arginine in a PCC/RNCC base, and a negative control group using a fluoride-free toothpaste in a PCC/RNCC base. Each participant will receive a soft-bristle toothbrush and the toothpastes assigned.
Between each five-day treatment phase, participants will have a nine-day washout period, using a fluoride-free toothpaste in a PCC/RNCC base. The study's eight-visit schedule includes a baseline visit, three treatment phases, three washout periods interspersed between the treatment phases, and a final visit. The primary outcome will be the measurement of changes in enamel microhardness, with assessments taking place both before and after each treatment to determine the impact on the enamel. The expected outcome is the confirmation of the alternative hypothesis, which predicts a reduction in the percentage of mineral loss from the surface of bovine enamel after using dentifrices containing 1000 ppm MFP with 1.5% arginine or herbal ingredients for five days each, compared to the control group. The percentage of mineral loss on the tooth surface relative to baseline will be used to quantify the extent of reduction in enamel demineralization. A two factor ANCOVA using the baseline as the covariate will be conducted to determine if a significant treatment effect exists. Adverse events and compliance will be closely monitored, with strict confidentiality maintained for all participants.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Group | Experimental | Subjects will brush using a fluoride free toothpaste in a chalk base with herbal ingredients and a soft bristle toothbrush |
|
| Positive Control Group | Active Comparator | Subjects will brush using a fluoride toothpaste containing 1000 ppm MFP and 1.5% arginine in a PCC/RNCC base and a soft bristle toothbrush |
|
| Negative Control Group | Sham Comparator | Subjects will brush using a fluoride free toothpaste in a PCC/RNCC base and a soft bristle toothbrush |
|
| Washout Group | Other | Subjects will brush using a fluoride free toothpaste in a PCC/RNCC base and a soft bristle toothbrush for 9 days, between the treatment phases. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoride free toothpaste in a chalk base | Drug | Fluoride free toothpaste in a chalk base with herbal ingredients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Microhardness change | The primary outcome of this study will be the change in the hardness of an intra-oral appliance before and after treatment. It will be determined by measuring the length of an indentation made on the appliance, which in turn allows for the calculation of its hardness value. The effectiveness of the treatment in reducing enamel demineralization by quantifying the percentage of mineral loss relative to the baseline will also be assessed. | 6 weeks |
Not provided
Not provided
Inclusion Criteria: Potential subjects must meet ALL of the following criteria:
Exclusion Criteria: Potential subjects must NOT HAVE ANY of the following conditions:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Natanael Santos, PhD | Federal University of Alagoas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of Alagoas | Maceió | Alagoas | 57072-970 | Brazil |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a Phase III, randomized, one-center, crossover group, triple blind, clinical study with an intra-oral enamel Demineralization - Remineralization In-Situ Model.
Not provided
Not provided
Not provided
| Fluoride Toothpaste | Drug | Fluoride toothpaste containing 1000 ppm MFP and 1.5% arginine in a PCC/RNCC base |
|
| Fluoride free toothpaste in a PCC/RNCC base | Drug | Fluoride free toothpaste in a PCC/RNCC base |
|
| Toothbrush | Device | A commercially available adult soft bristle toothbrush |
|
| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided