Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine whether an experimental fluoridated dentifrice is effective in the treatment of dental caries
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. Determination of fluoride uptake in-situ also provides better estimation of true fluoride bioavailability of fluoride dentifrice products. In this study, an in-situ remineralization fluoride uptake model will be used to compare the efficacy of experimental dentifrice with a marketed dentifrice and placebo dentifrice. Participants wore partial dentures containing two partially demineralized enamel specimens for two weeks- 24 hours per day, except when brushing (twice daily) with test dentifrice. Following each treatment period, the enamel specimens were analyzed for SMH recovery and fluoride uptake through microdrill enamel biopsy technique.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium fluoride/potassium nitrate/Isopentane dentifrice | Experimental | Participants to brush their teeth for one timed minute twice daily with a gel to foam dentifrice containing active ingredients: 1450 ppm F as sodium fluoride (NaF) and 5% potassium nitrate (KNO3) and isopentane as an excipient ingredient. |
|
| NaF/KNO3 Dentifrice | Experimental | Participants to brush their teeth for one timed minute twice daily with a gel to foam dentifrice, containing as active ingredients: 1450 ppm NaF and 5% KNO3 but no isopentane. |
|
| NaF Dentifrice | Active Comparator | Participants to brush their teeth for one timed minute twice daily with a dentifrice containing 1450 ppm F as NaF. |
|
| Placebo Dentifrice | Placebo Comparator | Participants to brush their teeth for one timed minute twice daily with a fluoride free dentifrice (0 ppm F). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NaF/ KNO3/isopentane Dentifrice | Drug | Experimental toothpaste |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Surface Micro-hardness Recovery (SMHR) of Enamel Specimens | SMH test was used to assess 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 re-hardening of enamel surface. Percent 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 |
|---|---|---|
| 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/cm^3. The difference between treatments was calculated with respect to fluoride uptake by enamel. | Baseline to 14 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
Not provided
Two to three days before the start of each treatment period participants got their teeth cleaned to remove all accessible plaque and calculus, and were provided with a fluoride free dentifrice for maintaining wash-out period and standardizing the oral conditions.
Participants were recruited at the clinical site.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Overall Study | This was a single-center, examiner blind, randomized, controlled, four treatment cross-over study. Participants have used each study product twice per day for two weeks and participated in each of the four treatment periods. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study Participants | All randomized participants who received all four treatments NaF/ KNO3/ 2% isopentane Dentifrice, NaF/KNO3/ 0% isopentane Dentifrice, NaF Dentifrice, and placebo were included in the baseline assessment. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Percentage Surface Micro-hardness Recovery (SMHR) of Enamel Specimens | SMH test was used to assess 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 re-hardening of enamel surface. Percent 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. | Per-Protocol (PP) population: All randomized participants who received at least one dose of study product, had at least one post-baseline efficacy assessments and no major protocol deviations. Missing data was not imputed. Due to drop-outs, there were differences in the "n" per treatment group. | Posted | Least Squares Mean | 95% Confidence Interval | % SMHR | Baseline to 14 days |
|
Up to 13 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NaF/ KNO3/ 2 % Isopentane Dentifrice | Participants brushed their teeth for one timed minute twice daily with a gel to foam dentifrice containing active ingredients: 1450 ppm F as NaF and 5% KNO3 and as an excipient ingredient: 2% isopentane. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gingival erythema | Gastrointestinal disorders |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D014077 | Tooth Erosion |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D057085 | Tooth Wear |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| NaF/KNO3 Dentifrice | Drug | Experimental toothpaste |
|
| NaF Dentifrice | Drug | Active comparator |
|
| Placebo Dentifrice | Other | Placebo comparator |
|
| Not capable of wearing partial denture |
|
| Cannot continue the study |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| NaF/ KNO3/ 2% Isopentane Dentifrice |
Participants brushed their teeth for one timed minute twice daily with a gel to foam dentifrice containing active ingredients: 1450 ppm F as NaF and 5% KNO3 and as an excipient ingredient: 2% isopentane. |
| OG001 | NaF/KNO3/ 0% Isopentane Dentifrice | Participants brushed their teeth for one timed minute twice daily with a gel to foam dentifrice, containing as active ingredients: 1450 ppm NaF and 5% KNO3 but no isopentane. |
| OG002 | NaF Dentifrice | Participants brushed their teeth for one timed minute twice daily with a dentifrice containing 1450 ppm F as NaF. |
| OG003 | Placebo Dentifrice | Participants brushed their teeth for one timed minute twice daily with a fluoride free dentifrice (0 ppm F). |
|
|
|
| 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/cm^3. 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 study product, had at least one post-baseline efficacy assessments and no major protocol deviations. Missing data was not imputed. Due to drop-outs, there were differences in the "n" per treatment group. | Posted | Least Squares Mean | 95% Confidence Interval | ug*F/cm^3 | Baseline to 14 days |
|
|
|
|
| 0 |
| 17 |
| 2 |
| 17 |
| EG001 | NaF/KNO3/ 0% Isopentane Dentifrice | Participants brushed their teeth for one timed minute twice daily with a gel to foam dentifrice, containing as active ingredients: 1450 ppm NaF and 5% KNO3 but no isopentane. | 0 | 17 | 3 | 17 |
| EG002 | NaF Dentifrice | Participants brushed their teeth for one timed minute twice daily with a dentifrice containing 1450 ppm F as NaF. | 0 | 18 | 4 | 18 |
| EG003 | Placebo Dentifrice | Participants brushed their teeth for one timed minute twice daily with a fluoride free dentifrice (0 ppm F). | 0 | 18 | 2 | 18 |
| Gingival ulceration | Gastrointestinal disorders |
|
| Food poisoning | Gastrointestinal disorders |
|
| Tongue coated | Gastrointestinal disorders |
|
| Localised infection | Infections and infestations |
|
| Nasopharyngitis | Infections and infestations |
|
| Tooth fracture | Injury, poisoning and procedural complications |
|
| Tooth infection | Infections and infestations |
|
Not provided
Not provided
| Null hypothesis was no difference between treatments. Tests were 2-sided. | ANOVA | The model included treatment and period as fixed and participant as random factors. | 0.7718 | No adjustments for multiple comparisons were made as the primary comparison was pre-defined. | Adjusted mean difference | -72.680 | 95 | -574.398 | 429.039 | 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. Tests were 2-sided. | ANOVA | The model included treatment and period as fixed and participant as random factors. | <0.0001 | No adjustments for multiple comparisons were made as the primary comparison was pre-defined. | Adjusted mean difference | 1784.675 | 95 | 1296.044 | 2273.306 | 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. Tests were 2-sided. | ANOVA | The model included tratment and period as fixed and participant as random factors. | 0.3164 | No adjustments for multiple comparisons were made as the primary comparison was pre-defined. | Adjusted mean difference | 248.758 | 95 | -245.962 | 743.478 | 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. Tests were 2-sided. | ANOVA | The model included treatment and period as fixed and participant as random factors. | <0.0001 | No adjustments for multiple comparisons were made as the primary comparison was pre-defined. | Adjusted mean difference | 2106.113 | 2-Sided | 95 | 1620.906 | 2591.320 | 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. Tests were 2-sided. | ANOVA | The model included treatment and period and fixed and participant as random factors. | <0.0001 | No adjustments for multiple comparisons were made as the primary comparison was pre-defined. | Adjusted mean difference | 1857.355 | 2-Sided | 95 | 1371.637 | 2343.072 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |