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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00708097 | In Situ Caries Efficacy of Fluoride Toothpastes | PHASE3 | COMPLETED | 57 | — | — | Apr 1, 2008 | Jul 1, 2008 | Jan 1, 2015 | 1 | United States |
SMH test was used to assess mineral status of partially demineralized enamel specimens using 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/demineralization while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline(B); after intra-oral exposure(R) on Day 14; and after in-vitro demineralization(D) on Day 14 using formula \[(D-R)/(D-B)\]\*100.
| Arm | Type | Description |
|---|---|---|
| NaF toothpaste(1450 ppmF) | EXPERIMENTAL | Study toothpaste containing 1450 ppm F as NaF and 0.4% carbopol as excipient. |
| NaF toothpaste (1400 ppmF) | ACTIVE_COMPARATOR | Study toothpaste containing 1400 ppm F as NaF |
| NaMFP/NaF toothpaste (1450 ppmF) | ACTIVE_COMPARATOR | Reference toothpaste containing 1000 ppm F as NaMFP and 450 ppm F as NaF |
| NaF toothpaste (675 ppmF) | ACTIVE_COMPARATOR | Study toothpaste containing 675 ppm F as NaF |
| Placebo toothpaste (0 ppmF) | PLACEBO_COMPARATOR | Fluoride free placebo toothpaste (0 ppm F) |
| Name | Type | Description |
|---|---|---|
| NaF | DRUG | Fluoride |
| Placebo | DRUG | Placebo |
| NaMFP | DRUG | Fluoride |
Inclusion Criteria: * Consent:Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form. * Age:Aged between 18 and 80 years. * Compliance:Understands and is willing,...