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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01607411 | A Clinical Study to Evaluate Experimental Children's Toothpastes in an In-Situ Caries Model | PHASE3 | COMPLETED | 55 | — | — | Feb 1, 2012 | May 1, 2012 | Aug 11, 2014 | 1 | United States |
| NCT00708305 | Evaluation of Plaque Fluid Fluoride Retention From Fluoride Toothpastes | PHASE3 | COMPLETED | 65 | — | — | Jun 1, 2008 | Oct 1, 2008 | Jan 1, 2015 | 1 | United States |
Surface microhardness recovery (SMHR) test was used to assess the changes in 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. Percent SMHR was calculated from indentation 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.
To evaluate fluoride content, plaque samples were collected from the interproximal surfaces of the posterior teeth of participants using a standardized approach. Plaque fluid fluoride were calculated using a micro analytical method and in comparison to a standard fluoride curve constructed on the same day of the analysis. AUC was determined from 0-4hours using trapezoidal rule and natural log transformation was applied due to failure of assumption of normal distribution of data.
| Arm | Type | Description |
|---|---|---|
| Fluoride free toothpaste | PLACEBO_COMPARATOR | toothpaste with no fluoride |
| 1426ppm Fluoride Toothpaste | EXPERIMENTAL | Experimental toothpaste containing 1426 ppm Fluoride |
| 1000 ppm Fluoride Toothpaste | EXPERIMENTAL | Experimental toothpaste containing 1000 ppm Fluoride |
| 500 ppm Toothpaste | EXPERIMENTAL | Experimental toothpaste containing 500 ppm Fluoride |
| NaF toothpaste (1450 parts per million [ppm] fluoride [F]) | EXPERIMENTAL | Participants brushed for one timed minute with 1.6g of NaF/silica and 0.4 percent carbopol toothpaste containing 1450ppmF as NaF. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds. |
| NaF toothpaste (1400ppmF) | ACTIVE_COMPARATOR | Participants brushed for one timed minute with 1.6g of NaF toothpaste containing 1400ppmF as NaF. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds. |
| Sodium monofluorophosphate (NaMFP)/ NaF toothpaste (1450ppmF)) | ACTIVE_COMPARATOR | Participants brushed for one timed minute with 1.6g of NaMFP/NaF toothpaste containing 1450ppmF from NaMFP and NaF. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds. |
| Placebo toothpaste (0ppmF) | PLACEBO_COMPARATOR | Participants brushed for one timed minute with 1.6g of fluoride free toothpaste. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds. |
| Name | Type | Description |
|---|---|---|
| Fluoride | DRUG | Fluoride Toothpaste |
| Placebo | DRUG | Fluoride free toothpaste |
| Sodium Fluoride (NaF) | DRUG | Different fluoride toothpastes containing between 1400ppmF - 1450ppmF of fluoride as NaF |
Inclusion Criteria: * Healthy males and females aged 11 to 14 inclusive who have an unstimulated salivary flow rate of at least 0.2 mL/minute and a stimulated salivary flow rate of at least 0.8 mL/minute (Screening Visit 1). Exclusion Criteria: \-