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This study will use an oral in-situ caries model to study remineralization of enamel due to the action of different combinations of fluoride salts delivered from dentifrices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluoride Toothpaste 1 | Experimental | Fluoride toothpaste containing sodium fluoride (NaF) |
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| Fluoride Toothpaste 2 | Experimental | Fluoride toothpaste containing stannous fluoride (SnF) and NaF. |
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| Fluoride Toothpaste 3 | Experimental | Fluoride toothpaste containing sodium monofluorophosphate (NaMFP) and NaF. |
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| Reference Dentifrice | Active Comparator | Low fluoride toothpaste containing NaF |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NaF | Drug | Fluoride toothpaste containing sodium fluoride as 1450 parts per million (ppm) F, 675 ppmF, 450 ppmF, 350ppmF. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage Surface Microhardness Recovery (%SMHR) of Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and SnF/NaF Toothpaste (1450ppmF) | SMH test was used to assess mineral status of partially demineralized enamel specimens using 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/demineralization, while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMH recovery 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 |
|---|---|---|
| %SMHR of Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), SnF/NaF Toothpaste (1450ppmF), NaMFP/NaF Toothpaste (1450ppmF) and NaF Toothpaste (675ppmF) | SMH test was used to assess mineral status of partially demineralized enamel specimens using 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/demineralization, while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMH recovery 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University School of Dentistry | Indianapolis | Indiana | 46202 | United States |
Two to three days before the start of each treatment period, participants received a professional dental cleaning of their natural teeth, then brushed with the study wash out toothpaste and toothbrush.
Participants were recruited at the clinical site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sodium Fluoride (NaF) Toothpaste(1450 Parts Per Million(Ppm)F | Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 gram (g) NaF toothpaste (1450ppmF as NaF), followed by rinsing with 15 milliliters (mL) water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures. |
| FG001 | Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF | Participants brushed their natural teeth twice daily, for one timed minute with 1.5g NaMFP and NaF toothpaste (1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures |
| FG002 | Strontium Fluoride (SnF)/NaF Toothpaste (1450ppmF | Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g SnF toothpaste (1100ppmF as SnF and 350ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures. |
| FG003 | NaF Toothpaste (675ppmF | Participants brushed their natural teeth twice daily, for one timed minute with NaF toothpaste (675ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period I |
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| Period II |
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| Period III |
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| Period IV |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | All randomized participants |
| 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 | Percentage Surface Microhardness Recovery (%SMHR) of Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and SnF/NaF Toothpaste (1450ppmF) | SMH test was used to assess mineral status of partially demineralized enamel specimens using 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/demineralization, while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMH recovery 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 treatment and with at least one post-baseline efficacy assessment but did not have any major protocol violations. Missing data was not imputed. Due to drop outs, there were differences in number of participants (N) per treatment group. | Posted | Mean | Standard Error | Percentage of SMHR | Baseline to 14 days |
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All adverse events 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 (1450ppmF) | Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g NaF toothpaste (1450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary Artery Disease | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| SnF | Drug | Fluoride toothpaste containing stannous fluoride (1100 ppmF) |
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| NaMFP | Drug | Fluoride toothpaste containing sodium monofluorophosphate (1000 ppmF) |
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| Baseline to 14 days |
| Change From Baseline in Enamel Fluoride Uptake Upon Exposure to NaF Toothpaste (1450ppmF), SnF/NaF Toothpaste (1450ppmF), NaMFP/NaF Toothpaste (1450ppmF) and NaF Toothpaste (675ppmF) | 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 |
| Withdrawal by Subject |
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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 |
|
| Title |
|---|
| Description |
|---|
| OG000 | NaF Toothpaste (1450ppmF) | Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g NaF toothpaste (1450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures. |
| OG001 | SnF/NaF Toothpaste (1450ppmF) | Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g SnF toothpaste (1100ppmF as SnF and 350ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures. |
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| Secondary | %SMHR of Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), SnF/NaF Toothpaste (1450ppmF), NaMFP/NaF Toothpaste (1450ppmF) and NaF Toothpaste (675ppmF) | SMH test was used to assess mineral status of partially demineralized enamel specimens using 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/demineralization, while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMH recovery 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. | PP population: All randomized participants, who received at least one dose of study treatment and with at least one post-baseline efficacy assessment but did not have any major protocol violations. Missing data was not imputed. Due to drop outs, there were differences in number of participants (N) per treatment group | Posted | Mean | Standard Error | Percentage | Baseline to 14 days |
|
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|
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| Secondary | Change From Baseline in Enamel Fluoride Uptake Upon Exposure to NaF Toothpaste (1450ppmF), SnF/NaF Toothpaste (1450ppmF), NaMFP/NaF Toothpaste (1450ppmF) and NaF Toothpaste (675ppmF) | 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 study treatment and with at least one post-baseline efficacy assessment but did not have any major protocol violations. Missing data was not imputed. Due to drop outs, there were differences in number of participants (N) per treatment group. | Posted | Mean | Standard Error | micrograms (μg)*F/centimeters(cm)^2] | Baseline to 14 days |
|
|
|
|
| 0 |
| 79 |
| 10 |
| 79 |
| EG001 | NaF Toothpaste (675ppmF) | Participants brushed their natural teeth twice daily, for one timed minute with NaF toothpaste (675ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures. | 0 | 79 | 12 | 79 |
| EG002 | NaMFP/NaF Toothpaste (1450ppmF) | Participants brushed their natural teeth twice daily, for one timed minute with 1.5g NaMFP and NaF toothpaste (1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures. | 1 | 80 | 18 | 80 |
| EG003 | SnF/NaF Toothpaste (1450ppmF) | Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g SnF toothpaste (1100ppmF as SnF and 350ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures. | 0 | 80 | 15 | 80 |
| Gastrointestinal Viral | Infections and infestations | Systematic Assessment |
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| Oral Herpes | Infections and infestations | Systematic Assessment |
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| Sinusitis | Infections and infestations | Systematic Assessment |
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| Bronchitis | Gastrointestinal disorders | Systematic Assessment |
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| Conjunctivitis Infective | Infections and infestations | Systematic Assessment |
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| Influenza | Infections and infestations | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
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| Vaginitis Bacterial | Infections and infestations | Systematic Assessment |
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| Gingival Erythema | Gastrointestinal disorders | Systematic Assessment |
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| Gingival Ulceration | Gastrointestinal disorders | Systematic Assessment |
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| Gingivitis | Gastrointestinal disorders | Systematic Assessment |
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| Lip ulceration | Gastrointestinal disorders | Systematic Assessment |
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| Mouth Ulceration | Gastrointestinal disorders | Systematic Assessment |
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| Chapped Lips | Gastrointestinal disorders | Systematic Assessment |
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| Dry Mouth | Gastrointestinal disorders | Systematic Assessment |
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| Mouth Hemorrhage | Gastrointestinal disorders | Systematic Assessment |
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| Oral Discomfort | Gastrointestinal disorders | Systematic Assessment |
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| Tongue Ulceration | Gastrointestinal disorders | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | Systematic Assessment |
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| Mouth Injury | Injury, poisoning and procedural complications | Systematic Assessment |
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| Thermal Burn | Injury, poisoning and procedural complications | Systematic Assessment |
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| Tongue Injury | Injury, poisoning and procedural complications | Systematic Assessment |
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| Ankle Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Incision Site Pain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Coccydynia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Burning Sensation | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Nerve Compression | Nervous system disorders | Systematic Assessment |
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| Conjunctivitis | Eye disorders | Systematic Assessment |
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| Seasonal Allergy | Immune system disorders | Systematic Assessment |
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| Diabetes Mellitus | Metabolism and nutrition disorders | Systematic Assessment |
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| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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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.
| Superiority or Other |
| Null hypothesis considered population means for treatments in comparison, to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05. | ANOVA | ANOVA with factors for treatment, study period and subject (random effect). | <0.0001 | No adjustments made for multiple comparisons as the primary comparison was pre-specified. | Adjusted Mean Difference | 12.20 | 2-Sided | 95 | 8.74 | 15.67 | 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 considered population means for treatments in comparison, to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05. | ANOVA | ANOVA with factors for treatment, study period and subject (random effect). | <0.0001 | No adjustments made for multiple comparisons as the primary comparison was pre-specified. | Adjusted Mean Difference | 12.31 | 2-Sided | 95 | 8.90 | 15.72 | 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 considered population means for treatments in comparison, to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05. | ANOVA | ANOVA with factors for treatment, study period and subject (random effect). | 0.4070 | No adjustments made for multiple comparisons as the primary comparison was pre-specified. | Adjusted Mean Difference | 1.46 | 2-Sided | 95 | -2.00 | 4.91 | 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 considered population means for treatments in comparison, to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05. | ANOVA | ANOVA with factors for treatment, study period and subject (random effect). | <0.0001 | No adjustments made for multiple comparisons as the primary comparison was pre-specified. | Adjusted Mean Difference | -10.85 | 2-Sided | 95 | -14.30 | -7.40 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Superiority or Other |
| Null hypothesis considered population means for treatments in comparison, to be equal with respect to enamel fluoride uptake. Statistical tests were 2-sided with a significance level of 0.05. | ANOVA | ANOVA with factors for treatment, study period and subject (random effect). | <0.0001 | No adjustments made for multiple comparisons as the primary comparison was pre-specified. | Adjusted Mean Difference | 8.79 | 2-Sided | 95 | 7.04 | 10.55 | 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 considered population means for treatments in comparison, to be equal with respect to enamel fluoride uptake. Statistical tests were 2-sided with a significance level of 0.05. | ANOVA | ANOVA with factors for treatment, study period and subject (random effect). | <0.0001 | No adjustments made for multiple comparisons as the primary comparison was pre-specified. | Adjusted Mean Difference | 8.03 | 2-Sided | 95 | 6.25 | 9.80 | 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 considered population means for treatments in comparison, to be equal with respect to enamel fluoride uptake. Statistical tests were 2-sided with a significance level of 0.05. | ANOVA | ANOVA with factors for treatment, study period and subject (random effect). | <0.0001 | No adjustments made for multiple comparisons as the primary comparison was pre-specified. | Adjusted Mean Difference | 4.41 | 2-Sided | 95 | 2.66 | 6.16 | 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 considered population means for treatments in comparison, to be equal with respect to enamel fluoride uptake. Statistical tests were 2-sided with a significance level of 0.05. | ANOVA | ANOVA with factors for treatment, study period and subject (random effect). | 0.3942 | No adjustments made for multiple comparisons as the primary comparison was pre-specified. | Adjusted Mean Difference | -0.77 | 2-Sided | 95 | -2.54 | 1.00 | 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 considered population means for treatments in comparison, to be equal with respect to enamel fluoride uptake. Statistical tests were 2-sided with a significance level of 0.05. | ANOVA | ANOVA with factors for treatment, study period and subject (random effect). | <0.0001 | No adjustments made for multiple comparisons as the primary comparison was pre-specified. | Adjusted Mean Difference | -5.18 | 2-Sided | 95 | -6.95 | -3.41 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |