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This study is to evaluate the effect of fluoride dentifrices on enamel with artificial caries lesions in an in situ model.
Topical fluorides have been proven to be clinically effective in the prevention of dental caries. It is generally agreed that anti-caries effect of fluoride (F) is mainly by decreasing the rate of enamel demineralization and enhancing the rate of enamel remineralization. An in-situ Surface Micro-hardness (SMH) test is widely used to evaluate enamel demineralization and remineralization during the caries process. The aim of this study was to evaluate the efficacy of toothpaste formulations containing fluoride from different sources [sodium fluoride (NaF) and sodium monofluorophosphate (NaMFP)] using an in situ caries model.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Placebo toothpaste (0 ppm F) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium fluoride toothpaste | Drug | Various fluoride toothpastes containing 1350 ppm F, 1450 ppm F, 1400 ppm F and 250 ppm F |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Percentage Surface Microhardness Recovery (%SMHR) of Enamel Specimens Exposed to NaF/Carbopol Toothpaste (1400 ppmF), NaF Toothpaste (1350ppmF) Compared to NaMFP/NaF Toothpaste (1450ppmF) | %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. | Baseline to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mean %SMHR of Enamel Specimens Exposed to NaF/Carbopol Toothpaste (1400 ppmF), NaF Toothpaste (1350ppmF), NaMFP/NaF Toothpaste (1450ppmF), NaF Toothpaste (250ppmF) and Placebo Toothpaste (0ppmF) | %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. |
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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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Two days, prior to each treatment visit ,participants used a fluoride- free dentifrice twice daily to avoid any carry over effect.
Participants were recruited at the clinical site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sodium Fluoride (NaF) Toothpaste[1350 Parts Per Million(Ppm)F] | Participants brushed 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. |
| FG001 | NaF/Carbopol Toothpaste (1400 Ppm F) | Participants brushed their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1400 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth. |
| FG002 | NaMFP/NaF Toothpaste (1450 Ppm F) | Participants brushed their natural teeth twice daily with a full ribbon of NaMFP and 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. |
| FG003 | NaF Toothpaste (250 Ppm F) | Participants brushed 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. |
| FG004 | Placebo Toothpaste (0 Ppm F) | Participants brushed 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. |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All randomized participants were included for baseline evaluation. |
| Units | Counts |
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| 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 | Mean Percentage Surface Microhardness Recovery (%SMHR) of Enamel Specimens Exposed to NaF/Carbopol Toothpaste (1400 ppmF), NaF Toothpaste (1350ppmF) Compared to NaMFP/NaF Toothpaste (1450ppmF) | %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. | Intent to treat population: All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to subject drop outs, there are differences in the "n" per treatment group. | Posted | Least Squares Mean | Standard Error | %SMHR | Baseline to 14 days |
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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/ Carbopol Toothpaste (1400 Ppm F) | Participants brushed their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1400 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth. |
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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 |
|---|---|
| D005459 | Fluorides |
| ID | Term |
|---|---|
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D006858 |
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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. |
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| Placebo toothpaste | Drug | Fluoride free toothpaste (0 ppm F) |
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| Baseline to 14 days |
| Adjusted Mean Change From Baseline in Enamel Fluoride Uptake | 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 and expressed as ug F/cm2. The difference between treatments was calculated with respect to fluoride uptake by enamel. | Baseline to 14 days |
| Adverse Event |
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| COMPLETED |
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| NOT 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 |
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| OG000 |
| NaF/Carbopol Toothpaste (1400 Ppm F) |
Participants brushed their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1400 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth. |
| OG001 | NaF Toothpaste (1350 Ppm F) | Participants brushed 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. |
| OG002 | NaMFP/NaF Toothpaste (1450 Ppm F) | Participants brushed their natural teeth twice daily with a full ribbon of NaMFP and NaF toothpaste (1450 ppm F - 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial dentures from their mouth. |
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| Secondary | Mean %SMHR of Enamel Specimens Exposed to NaF/Carbopol Toothpaste (1400 ppmF), NaF Toothpaste (1350ppmF), NaMFP/NaF Toothpaste (1450ppmF), NaF Toothpaste (250ppmF) and Placebo Toothpaste (0ppmF) | %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. | ITT population: All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop outs, there were differences in the "n" per treatment group. | Posted | Least Squares Mean | Standard Error | %SMHR | Baseline to 14 days |
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| Secondary | Adjusted Mean Change From Baseline in Enamel Fluoride Uptake | 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 and expressed as ug F/cm2. The difference between treatments was calculated with respect to fluoride uptake by enamel. | ITT population: All randomized participants who had a least one post baseline efficacy assessment. Missing data was not imputed. Due to drop outs, there were differences in the "n" per treatment group. | Posted | Least Squares Mean | Standard Error | µg*F/cm^2 | Baseline to 14 days |
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| 0 |
| 56 |
| 4 |
| 56 |
| EG001 | NaF Toothpaste (1350ppm F) | Participants brushed 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. | 0 | 54 | 4 | 54 |
| EG002 | NaMFP/NaF Toothpaste (1450 Ppm F) | Participants brushed their natural teeth twice daily with a full ribbon of NaMFP and 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. | 0 | 55 | 1 | 55 |
| EG003 | NaF Toothpaste (250 Ppm F) | Participants brushed 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. | 0 | 56 | 1 | 56 |
| EG004 | Placebo Toothpaste (0 Ppm F) | Participants brushed 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. | 0 | 54 | 2 | 54 |
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.
| Hydrofluoric Acid |
| D017611 | Fluorine Compounds |
| Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level. | ANOVA | ANOVA with factors for treatment, study period, and subject as random effect. | <0.0001 | No adjustments made for multiple comparisons as the primary comparison was pre-specified. | Adjusted Mean Difference | 10.26 | 2-Sided | 95 | 6.76 | 13.76 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level. | ANOVA | ANOVA with factors for treatment, study period, and subject as random effect | <0.0001 | No adjustment was made for multiple comparisons as the primary comparisons were pre-defined. | Adjusted Mean Difference | 13.19 | 2-Sided | 95 | 9.69 | 16.68 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level. | ANOVA | ANOVA with factors for treatment, study period, and subject as random effect | <0.0001 | No adjustment was made for multiple comparisons as the primary comparisons were pre-defined. | Adjusted Mean Difference | 8.57 | 2-Sided | 95 | 5.09 | 12.05 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level. | ANOVA | ANOVA with factors for treatment, study period, and subject (random effect). | <0.0001 | No adjustment was made for multiple comparisons as the primary comparisons were pre-defined. | Adjusted Mean Difference | 11.50 | 2-Sided | 95 | 8.01 | 14.98 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level. | ANOVA | ANOVA with factors for treatment, study period, and subject as random effect | 0.0104 | No adjustment was made for multiple comparisons as the primary comparisons were pre-defined. | Adjusted Mean Difference | -4.59 | 2-Sided | 95 | -8.10 | -1.09 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level. | ANOVA | ANOVA with factors for treatment, study period, and subject as random effect | <0.0001 | No adjustment was made for multiple comparisons as the primary comparisons were pre-defined. | Adjusted Mean Difference | 7.52 | 2-Sided | 95 | 4.04 | 11.01 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level. | ANOVA | ANOVA with factors for treatment, study period, and subject as random effect. | 0.0986 | No adjustment was made for multiple comparisons as the primary comparisons were pre-defined. | Adjusted Mean DIfference | 2.93 | 2-Sided | 95 | -0.55 | 6.41 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level. | ANOVA | ANOVA with factors for treatment, study period, and subject as random effect | 0.0024 | No adjustment was made for multiple comparisons as the primary comparisons were pre-defined. | Adjusted Mean Difference | 246.70 | 2-Sided | 95 | 88.30 | 405.10 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level. | ANOVA | ANOVA with factors for treatment, study period, and subject as random effect | 0.5328 | No adjustment was made for multiple comparisons as the primary comparisons were pre-defined. | Adjusted Mean Difference | -49.96 | 2-Sided | 95 | -207.62 | 107.71 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level. | ANOVA | ANOVA with factors for treatment, study period, and subject as random effect | <0.0001 | No adjustment was made for multiple comparisons as the primary comparisons were pre-defined. | Mean Difference (Final Values) | -406.19 | 2-Sided | 95 | -564.00 | -248.37 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level. | ANOVA | ANOVA with factors for treatment, study period, and subject as random effect | <0.0001 | No adjustment was made for multiple comparisons as the primary comparisons were pre-defined. | Adjusted Mean Difference | 602.93 | 2-Sided | 95 | 445.97 | 759.90 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level. | ANOVA | ANOVA with factors for treatment, study period, and subject as random effect | <0.0001 | No adjustment was made for multiple comparisons as the primary comparisons were pre-defined. | Adjusted Mean Difference | 652.89 | 2-Sided | 95 | 495.05 | 810.72 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level. | ANOVA | ANOVA with factors for treatment, study period, and subject as random effect | <0.0001 | No adjustment was made for multiple comparisons as the primary comparisons were pre-defined. | Adjusted Mean Difference | 847.55 | 2-Sided | 95 | 690.54 | 1004.55 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level. | ANOVA | ANOVA with factors treatment, period and subject as random effect. | <0.0001 | No adjustment was made for multiple comparisons as the primary comparisons were pre-defined. | Adjusted Mean Difference | 897.50 | 2-Sided | 95 | 739.92 | 1055.08 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level. | ANOVA | ANOVA with factors for treatment, study period, and subject as random effect | <0.0001 | No adjustment was made for multiple comparisons as the primary comparisons were pre-defined. | Adjusted Mean Difference | 650.80 | 2-Sided | 95 | 493.61 | 808.00 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level. | ANOVA | ANOVA with factors for treatment, study period, and subject as random effect | 0.0024 | No adjustment was made for multiple comparisons as the primary comparisons were pre-defined. | Adjusted Mean Difference | 244.62 | 2-Sided | 95 | 87.62 | 401.61 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |