Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Calcium sodium phosphosilicate
Calcium phosphosilicate · 1 trial · 1 indication
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 \[required dimensions 12 x 7 millimeters (mm)\].
Calcium phosphosilicate is a small molecule being developed by GSK plc for caries, also known as dental cavities. It is an investigational agent in Phase 2 clinical development and has not been approved by the FDA. It is also known as calcium sodium phosphosilicate.
Calcium phosphosilicate is being studied for the treatment or prevention of caries, a dental condition involving tooth decay. It is in Phase 2 development and is not yet approved for any indication. The only completed trial enrolled 100 participants with caries.
Calcium phosphosilicate is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program evaluating this small molecule for caries.
Calcium phosphosilicate is in Phase 2 clinical development. One Phase 2 trial has been completed, and there are no active trials at this time. The drug is investigational and has not received FDA approval.
Calcium phosphosilicate has been evaluated in one completed Phase 2 trial, NCT01657877, titled "Anti-caries Potential of a Sodium Monofluorophosphate and Calcium Sodium Phosphosilicate Dentifrice." The trial enrolled 100 participants in the United States, was randomized, double-blind, and placebo-controlled, and included healthy volunteers aged 18 years and older.
Yes, calcium phosphosilicate is also known as calcium sodium phosphosilicate. Both names refer to the same small molecule being developed by GSK plc for caries.