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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00708123 | In Situ Caries of Fluoride Toothpastes | PHASE3 | COMPLETED | 60 | — | — | Nov 1, 2007 | Apr 1, 2008 | Apr 22, 2013 | - | — |
%SMHR test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. %SMHR 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 rehardening of enamel surface. %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 (NaF) toothpaste[1350 parts per million(ppm)F] | ACTIVE_COMPARATOR | Participants to brush their natural teeth twice daily with a full ribbon of NaF toothpaste (1350 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth. |
| NaF/Carbopol toothpaste (1400 ppm F) | EXPERIMENTAL | Participants to brush their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth. |
| NaMFP/NaF toothpaste (1450 ppm F) | ACTIVE_COMPARATOR | Participants to brush their natural teeth twice daily with a full ribbon of NaMFPand NaF toothpaste (1450 ppm F - 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth. |
| NaF toothpaste (250 ppm F) | ACTIVE_COMPARATOR | Participants to brush their natural teeth twice daily with a full ribbon of NaF toothpaste (250 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth. |
| Placebo toothpaste (0 ppm F) | PLACEBO_COMPARATOR | Participants to brush their natural teeth twice daily with a full ribbon of fluoride free toothpaste (0 ppm F) for one timed minute, after removing their partial denture from their mouth. |
| Name | Type | Description |
|---|---|---|
| Sodium fluoride toothpaste | DRUG | Various fluoride toothpastes containing 1350 ppm F, 1450 ppm F, 1400 ppm F and 250 ppm F |
| Placebo toothpaste | DRUG | Fluoride free toothpaste (0 ppm F) |
Inclusion Criteria 1. 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. 2. Age:Aged between 18 and 78 years. 3. Compliance:Understands and is willi...