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This study is to evaluate the effect of fluoride dentrifrices on enamel with artificial caries lesions in an in situ model
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Run in | Other | Placebo |
|
| Sodium Fluoride Toothpaste | Experimental | Sodium fluoride toothpaste |
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| Amine Fluoride Toothpaste | Active Comparator | Amine Fluoride |
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| 675ppmf toothpaste | Other | Dose response |
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| Sodium monofluorophosphate/sodium fluoride Toothpaste | Active Comparator | Sodium monofluorophosphate/sodium fluoride Toothpaste |
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| 0 ppmf toothpaste | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Fluoride Toothpaste | Drug | Test product |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Surface Microhardness (SMH) Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF) and AmF Toothpaste (1400ppmF) | SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a 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 while decrease in the indentation length represents rehardening of enamel surface. Difference in percent SMH recovery was calculated by comparing study NaF toothpaste (1426ppmF) with reference AmF toothpaste (1400ppmF). | Baseline to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percent SMH Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste (1400ppm F) and Placebo (0ppmF) | SMH test was used to assess the changes in mineralization status of enamel specimens using a 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 while decrease in the indentation length represents rehardening of enamel surface. Differences in percent SMH recovery due to study and reference toothpastes were calculated. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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83 participants were screened and 18 participants did not meet the study criteria thus 65 participants were enrolled into the study. The subjects were randomized to receive all 5 study treatments in a pre-determined computerized randomised order as per a typical cross-over design.
Participants were recruited at the clinical site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sodium Fluoride(NaF) Toothpaste[1426parts Per Million(Ppm)F] | Study toothpaste containing sodium fluoride/ silica (1426ppm fluoride as NaF) |
| FG001 | Amine Fluoride(AmF) Toothpaste (1400ppmF) | Reference toothpaste containing amine fluoride (1400ppm fluoride as AmF) |
| FG002 | Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF) | Reference toothpaste containing sodium monofluorophosphate and sodium fluoride (1450ppmF - 1000ppmF as NaMFP and 450ppmF as NaF) |
| FG003 | NaF Toothpaste (675ppmF) | Study toothpaste containing sodium fluoride and silica (675ppmF as NaF) |
| FG004 | Placebo Toothpaste (0ppmF) | Placebo fluoride free toothpaste |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 (14 Days) |
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| Washout Period 1 (4 Days) |
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| Treatment Period 2 (14 Days) |
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| Washout Period 2 (4 Days) |
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| Treatment Period 3 (14 Days) |
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| Washout Period 3 ( 4 Days) |
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| Treatment Period 4 (14 Days) |
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| Washout Period 4 (4 Days) |
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| Treatment Period 5 (14 Days) |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Randomized Participants | All randomized participants who received at least one dose of the study treatments or who have been evaluated for AEs were included. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Surface Microhardness (SMH) Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF) and AmF Toothpaste (1400ppmF) | SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a 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 while decrease in the indentation length represents rehardening of enamel surface. Difference in percent SMH recovery was calculated by comparing study NaF toothpaste (1426ppmF) with reference AmF toothpaste (1400ppmF). | Per protocol (PP) population: All randomized participants who received at least one dose of the study treatments and provided at least one measurement SMH. Participants without any major protocol violations in given study treatment period were included in the PP population. | Posted | Mean | Standard Error | Percentage SMHR | Baseline to 14 days |
|
All AEs encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NaF Toothpaste (1426ppmF) | Study toothpaste containing NaF/ silica (1426ppmF) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| C012980 | fluorophosphate |
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| Amine Fluoride Toothpaste |
| Drug |
Test product |
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| Sodium monofluorophosphate/Sodium Fluoride Toothpaste | Drug | test product |
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| Placebo | Drug | placebo and washout treatment |
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| 675 ppmf toothpaste | Drug | dose response |
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| Baseline to 14 days |
| Change From Baseline in Enamel Fluoride Uptake Potential | Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores. The difference between treatments was calculated with respect to fluoride uptake by enamel. | Baseline to 14 days |
| Protocol Violation |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| NaF Toothpaste (1426ppmF) |
Study toothpaste containing NaF/ silica (1426ppmF) |
| OG001 | AmF Toothpaste (1400ppmF) | Reference toothpaste containing AmF (1400ppmF) |
|
|
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| Secondary | Percent SMH Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste (1400ppm F) and Placebo (0ppmF) | SMH test was used to assess the changes in mineralization status of enamel specimens using a 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 while decrease in the indentation length represents rehardening of enamel surface. Differences in percent SMH recovery due to study and reference toothpastes were calculated. | PP population: All randomized participants who received at least one dose of the study treatments or provided at least one measurement SMH. Participants without any major protocol violations in given study treatment period were included in the PP population. | Posted | Mean | Standard Error | Percentage SMHR | Baseline to 14 days |
|
|
|
|
| Secondary | Change From Baseline in Enamel Fluoride Uptake Potential | Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores. The difference between treatments was calculated with respect to fluoride uptake by enamel. | PP population: All randomized participants who received at least one dose of the study treatments or provided at least one significant measurement of fluoride uptake. Participants without any major protocol violations in given study treatment period were included in the PP population. | Posted | Mean | Standard Error | micrograms (μg)* F/centimeters(cm)^2 | Baseline to 14 days |
|
|
|
|
| 0 |
| 57 |
| 1 |
| 57 |
| EG001 | AmF Toothpaste (1400ppmF) | Reference toothpaste containing AmF (1400ppmF) | 0 | 57 | 5 | 57 |
| EG002 | NaMFP/ NaF Toothpaste (1450ppmF) | Reference toothpaste containing NaMFP/ NaF (1450ppmF - 1000ppmF as NaMFP and 450ppmF as NaF) | 0 | 59 | 0 | 59 |
| EG003 | NaF Toothpaste (675ppmF) | Toothpaste containing NaF/ silica (675ppmF) | 0 | 59 | 3 | 59 |
| EG004 | Placebo Toothpaste (0ppmF) | Placebo: fluoride free toothpaste | 0 | 59 | 2 | 59 |
| EG005 | Overall | 0 | 65 | 10 | 65 |
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and Na MFP/NaF toothpaste (1450ppmF) to be equal with respect to enamel remineralization potential. | ANOVA | ANOVA based on a mixed model with factors subject, treatment and period was used. | 0.0557 | No adjustment made for multiple comparisons as the primary comparison was pre-specified. | Adjusted Mean Difference | 4.57 | 95 | -0.11 | 9.24 | Statistical tests were 2-sided with a significance level of 0.05. | No | Superiority or Other |
| Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and Placebo toothpaste (0ppmF) to be equal with respect to enamel remineralization potential. | ANOVA | ANOVA based on a mixed model with factors subject, treatment and period was used. | <0.0001 | No adjustment made for multiple comparisons as the primary comparison was pre-specified. | Adjusted Mean Difference | 23.55 | 2-Sided | 95 | 18.86 | 28.24 | Statistical tests were 2-sided with a significance level of 0.05. | No | Superiority or Other |
| Null hypothesis considered population means for the Na MFP/NaF toothpaste (1450ppmF) and NaF toothpaste (675ppmF) to be equal with respect to enamel remineralization potential. | ANOVA | ANOVA based on a mixed model with factors subject, treatment and period was used. | 0.0625 | No adjustment made for multiple comparisons as the primary comparison was pre-specified. | Adjusted Mean Difference | 4.40 | 2-Sided | 95 | -0.23 | 9.03 | Statistical tests were 2-sided with a significance level of 0.05. | No | Superiority or Other |
| Null hypothesis considered population means for the Na MFP/NaF toothpaste (1450ppmF) and Placebo toothpaste (0ppmF) to be equal with respect to enamel remineralization potential. | ANOVA | ANOVA based on a mixed model with factors subject, treatment and period was used. | <0.0001 | No adjustment made for multiple comparisons as the primary comparison was pre-specified. | Adjusted Mean Difference | 18.99 | 2-Sided | 95 | 14.36 | 23.61 | Statistical tests were 2-sided with a significance level of 0.05. | No | Superiority or Other |
| Null hypothesis considered population means for the NaF toothpaste (675ppmF) and Placebo toothpaste (0ppmF) to be equal with respect to enamel remineralization potential. | ANOVA | ANOVA based on a mixed model with factors subject, treatment and period was used. | <0.0001 | No adjustment made for multiple comparisons as the primary comparison was pre-specified. | Adjusted Mean Difference | 14.59 | 2-Sided | 95 | 9.95 | 19.23 | Statistical tests were 2-sided with a significance level of 0.05. | No | Superiority or Other |
| Null hypothesis considered population means for the AmF toothpaste (1400ppmF) and Na MFP/NaF toothpaste (1450ppmF) to be equal with respect to enamel remineralization potential. | ANOVA | ANOVA based on a mixed model with factors subject, treatment and period was used. | 0.0017 | No adjustment made for multiple comparisons as the primary comparison was pre-specified. | Adjusted Mean Difference | 7.58 | 2-Sided | 95 | 2.88 | 12.27 | Statistical tests were 2-sided with a significance level of 0.05. | No | Superiority or Other |
| Null hypothesis considered population means for AmF toothpaste (1400ppmF) and NaF toothpaste (675ppmF) to be equal with respect to enamel remineralization potential. | ANOVA | ANOVA based on a mixed model with factors subject, treatment and period was used. | <0.0001 | No adjustment made for multiple comparisons as the primary comparison was pre-specified. | Adjusted Mean Difference | 11.97 | 2-Sided | 95 | 7.31 | 16.64 | Statistical tests were 2-sided with a significance level of 0.05. | No | Superiority or Other |
| Null hypothesis considered population means for AmF toothpaste (1400ppmF) and placebo toothpaste (0ppmF) to be equal with respect to enamel remineralization potential. | ANOVA | ANOVA based on a mixed model with factors subject, treatment and period was used. | <0.0001 | No adjustment made for multiple comparisons as the primary comparison was pre-specified. | Adjusted Mean Difference | 26.56 | 2-Sided | 95 | 21.88 | 31.24 | Statistical tests were 2-sided with a significance level of 0.05. | No | Superiority or Other |
| Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and Na MFP/NaF toothpaste (1450ppmF) to be equal with respect to enamel fluoride uptake potential. | ANOVA | ANOVA based on a mixed model with factors subject, treatment and period was used. | 0.0002 | No adjustment made for multiple comparisons as the primary comparison was pre-specified. | Adjusted Mean Difference | 532.61 | 2-Sided | 95 | 259.06 | 806.16 | Statistical tests were 2-sided with a significance level of 0.05. | No | Superiority or Other |
| Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and NaF toothpaste (675ppmF) to be equal with respect to enamel fluoride uptake potential. | ANOVA | ANOVA based on a mixed model with factors subject, treatment and period was used. | <0.0001 | No adjustment made for multiple comparisons as the primary comparison was pre-specified. | Adjusted Mean Difference | 692.91 | 2-Sided | 95 | 418.73 | 967.09 | Statistical tests were 2-sided with a significance level of 0.05 | No | Superiority or Other |
| Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and Placebo toothpaste (0ppmF) to be equal with respect to enamel fluoride uptake potential. | ANOVA | ANOVA based on a mixed model with factors subject, treatment and period was used. | <0.0001 | No adjustment made for multiple comparisons as the primary comparison was pre-specified. | Adjusted Mean Difference | 1879.40 | 2-Sided | 95 | 1605.75 | 2153.04 | Statistical tests were 2-sided with a significance level of 0.05. | No | Superiority or Other |
| Null hypothesis considered population means for AmF toothpaste (1400ppmF) and Na MFP/ NaF toothpaste (1450ppmF) and to be equal with respect to enamel fluoride uptake potential. | ANOVA | ANOVA based on a mixed model with factors subject, treatment and period was used. | 0.0005 | No adjustment made for multiple comparisons as the primary comparison was pre-specified. | Adjusted Mean Difference | 495.38 | 2-Sided | 95 | 221.09 | 769.66 | Statistical tests were 2-sided with a significance level of 0.05. | No | Superiority or Other |
| Null hypothesis considered population means for AmF toothpaste (1400ppmF) and NaF toothpaste (675ppmF) to be equal with respect to enamel fluoride uptake potential. | ANOVA | ANOVA based on a mixed model with factors subject, treatment and period was used. | <0.0001 | No adjustment made for multiple comparisons as the primary comparison was pre-specified. | Adjusted Mean Difference | 655.67 | 2-Sided | 95 | 382.41 | 928.93 | Statistical tests were 2-sided with a significance level of 0.05. | No | Superiority or Other |
| Null hypothesis considered population means for AmF toothpaste (1400ppmF) and placebo toothpaste (0ppmF) to be equal with respect to enamel fluoride uptake potential. | ANOVA | ANOVA based on a mixed model with factors subject, treatment and period was used. | <0.0001 | No adjustment made for multiple comparisons as the primary comparison was pre-specified. | Adjusted Mean Difference | 1842.16 | 2-Sided | 95 | 1568.73 | 2115.60 | Statistical tests were 2-sided with a significance level of 0.05. | No | Superiority or Other |
| Null hypothesis considered population means for the Na MFP/NaF toothpaste (1450ppmF) and NaF toothpaste (675ppmF) to be equal with respect to enamel fluoride uptake potential. | ANOVA | ANOVA based on a mixed model with factors subject, treatment and period was used. | 0.2448 | No adjustment made for multiple comparisons as the primary comparison was pre-specified. | Adjusted Mean Difference | 160.30 | 2-Sided | 95 | -110.58 | 431.18 | Statistical tests were 2-sided with a significance level of 0.05. | No | Superiority or Other |
| Null hypothesis considered population means for the Na MFP/NaF toothpaste (1450ppmF) and Placebo toothpaste (0ppmF) to be equal with respect to enamel fluoride uptake potential. | ANOVA | ANOVA based on a mixed model with factors subject, treatment and period was used. | <0.0001 | No adjustment made for multiple comparisons as the primary comparison was pre-specified. | Adjusted Mean Difference | 1346.79 | 2-Sided | 95 | 1076.46 | 1617.11 | Statistical tests were 2-sided with a significance level of 0.05. | No | Superiority or Other |
| Null hypothesis considered population means for the NaF toothpaste (675ppmF) and Placebo toothpaste (0ppmF) to be equal with respect to enamel fluoride uptake potential. | ANOVA | ANOVA based on a mixed model with factors subject, treatment and period was used. | <0.0001 | No adjustment made for multiple comparisons as the primary comparison was pre-specified. | Adjusted Mean Difference | 1186.49 | 2-Sided | 95 | 915.38 | 1457.60 | Statistical tests were 2-sided with a significance level of 0.05. | No | Superiority or Other |