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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01657877 | Anti-caries Potential of a Sodium Monofluorophosphate and Calcium Sodium Phosphosilicate Dentifrice | PHASE2 | COMPLETED | 100 | — | — | May 1, 2012 | Jun 1, 2013 | Oct 1, 2014 | 1 | United States |
Percent SMH recovery (SMHR) was calculated from hardness values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: \[(D1-R)/ (D1-B)\]\*100. A greater percentage change in SMHR represents a better remineralisation and hence a better outcome.
| Arm | Type | Description |
|---|---|---|
| CSP/SMFP Dentifrice | EXPERIMENTAL | Dentifrice containing high fluoride content as SMFP and CSP |
| SMFP Dentifrice Prototype 1 | ACTIVE_COMPARATOR | Dentifrice containing high fluoride content as SMFP and no CSP |
| SMFP Dentifrice Prototype 2 | ACTIVE_COMPARATOR | Dentifrice containing low fluoride content as SMFP and no CSP |
| CSP Dentifrice | ACTIVE_COMPARATOR | Dentifrice containing CSP but no fluoride |
| Placebo Dentifrice | PLACEBO_COMPARATOR | Dentifrice containing no CSP and no fluoride |
| Name | Type | Description |
|---|---|---|
| Calcium sodium phosphosilicate | DRUG | CSP high percentage weight by weight |
| Sodium monoflurophosphate | DRUG | 500 to 1500 parts per million (ppm) of fluoride |
| Placebo | DRUG | No CSP and no fluoride |
Inclusion Criteria: * Wears a removable bilateral mandibular partial denture that has good stability and support, with sufficient room on each side in the posterior buccal flange area to accommodate two enamel specimens \[required dimensions 12 x 7 millimeters (mm)\].