Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00752089 | Experimental Dentifrice Remineralization/Fluoride Uptake in an in Situ Model | PHASE2 | COMPLETED | 20 | — | — | Sep 1, 2007 | Jan 1, 2008 | Dec 8, 2016 | - | — |
SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after intra-oral exposure (R) and after in-vitro demineralization (D) using formula: \[(D-R)/ (D-B)\]\*100.
| Arm | Type | Description |
|---|---|---|
| Sodium fluoride/potassium nitrate/Isopentane dentifrice | EXPERIMENTAL | Participants to brush their teeth for one timed minute twice daily with a gel to foam dentifrice containing active ingredients: 1450 ppm F as sodium fluoride (NaF) and 5% potassium nitrate (KNO3) and isopentane as an excipient ingredient. |
| NaF/KNO3 Dentifrice | EXPERIMENTAL | Participants to brush their teeth for one timed minute twice daily with a gel to foam dentifrice, containing as active ingredients: 1450 ppm NaF and 5% KNO3 but no isopentane. |
| NaF Dentifrice | ACTIVE_COMPARATOR | Participants to brush their teeth for one timed minute twice daily with a dentifrice containing 1450 ppm F as NaF. |
| Placebo Dentifrice | PLACEBO_COMPARATOR | Participants to brush their teeth for one timed minute twice daily with a fluoride free dentifrice (0 ppm F). |
| Name | Type | Description |
|---|---|---|
| NaF/ KNO3/isopentane Dentifrice | DRUG | Experimental toothpaste |
| NaF/KNO3 Dentifrice | DRUG | Experimental toothpaste |
| NaF Dentifrice | DRUG | Active comparator |
| Placebo Dentifrice | OTHER | Placebo comparator |
Inclusion Criteria: 1. Age: Aged between 18 and 78 2. Fluoride: Currently living in the Indianapolis area which has a fluoridated water supply (1 ppm F) and not taking fluoride supplements for medical reasons 3. Dentures: Currently wearing a removable mandibular partial denture with sufficient room...