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This exploratory study is designed to help develop a clinical model to measure the earlier stages of dietary acid medicated enamel loss. The study will use fluoride as positive control to explore the validity of this design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Product | Experimental | Subjects will apply a full ribbon of dentifrice and brush their teeth for 1 timed minute using a wetted toothbrush, swish the resulting slurry around the mouth for 30 seconds making sure it contacts the selected teeth, spit out slurry and rinse mouth for 10 seconds with water. |
|
| Reference Product | Placebo Comparator | Subjects will apply a full ribbon of dentifrice and brush their teeth for 1 timed minute using a wetted toothbrush, swish the resulting slurry around the mouth for 30 seconds making sure it contacts the selected teeth, spit out slurry and rinse mouth for 10 seconds with water. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium fluoride + potassium nitrate | Other | Marketed toothpaste containing 1450ppm fluoride as sodium fluoride and 5% potassium nitrate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Immediately Following an Acid Challenge | The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography. The Images were graded as follows:
| Baseline, 30 minutes post dietary acid challenge |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 2 Hours Post Acid Challenge. | The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography. The Images were graded as follows:
|
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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 |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Bristol | BS1 2LY | United Kingdom |
A total of 30 participants were screened and all of them were randomized.
Participants were recruited at 1 center in United Kingdom.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Product | Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water. |
| FG001 | Reference Product | Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The Per Protocol (PP) population was the primary population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Product | Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush and swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water. |
| BG001 |
| 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 | Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Immediately Following an Acid Challenge | The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography. The Images were graded as follows:
| The Per Protocol (PP) population was defined as those subjects in the ITT (intent to treat) population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation were excluded from PP analyses. The primary population was the PP population. | Posted | Median | Full Range | Scores on grading scale | Baseline, 30 minutes post dietary acid challenge |
Baseline upto Day 2
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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 | Test Product | Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D014077 | Tooth Erosion |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D057085 | Tooth Wear |
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| ID | Term |
|---|---|
| D012969 | Sodium Fluoride |
| C023844 | potassium nitrate |
| ID | Term |
|---|---|
| D005459 | Fluorides |
| D006858 | Hydrofluoric Acid |
| D017611 | Fluorine Compounds |
| D007287 | Inorganic Chemicals |
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| Potassium nitrate | Other | Experimental toothpaste containing 5% potassium nitrate |
|
| Baseline, 2 hours post acid challenge |
| Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 4 Hours Post Acid Challenge | The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography. The Images were graded as follows:
| Baseline, 4 hours post acid challenge |
| Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 7 Hours Post Acid Challenge | The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography. The Images were graded as follows:
| Baseline, 7 hours post acid challenge |
| Change From Baseline of Salivary Calcium Concentration at 30 Mins Post Dietary Acid Challenge | Saliva stored at 0 - 20°C was used for determining calcium concentration | Baseline, 30 mins post dietary acid challenge |
| Change From Baseline of Salivary Calcium Concentration 7 Hours Post Dietary Acid Challenge | Saliva stored at 0 - 20°C was used for determining calcium concentration | Baseline, 7 hours post dietary acid challenge |
| Change From Baseline of pH Measurement at 30 Mins Post Dietary Acid Challenge | Saliva stored at 0 - 20°C was used for determining pH | Baseline, 30 mins post dietary acid challenge |
| Change From Baseline of pH Measurement 7 Hours Post Dietary Acid Challenge | Saliva stored at 0 - 20°C was used for determining pH | Baseline, 7 hours post dietary acid challenge |
| Change From Baseline in Buffering Capacity at 30 Mins Post Dietary Acid Challenge | Saliva was collected and stored at 0 - 20°C. A Saliva-check Buffer Kit was used to determine the buffer capacity. The colourimetric assay yielded a coloured pattern on a paper diagnostic using a 0-12 scale where 0-5 was deemed to be very low, 6-9 was deemed low and 10-12 was deemed normal-high. | Baseline, 30 mins post dietary acid challenge |
| Change From Baseline in Buffering Capacity 7 Hours Post Dietary Acid Challenge | Saliva was collected and stored at 0 - 20°C. A Saliva-check Buffer Kit was used to determine the buffer capacity. The colourimetric assay yielded a coloured pattern on a paper diagnostic using a 0-12 scale where 0-5 was deemed to be very low, 6-9 was deemed low and 10-12 was deemed normal-high. | Baseline, 7 hours post dietary acid challenge |
| Reference Product |
Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Test Product | Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water. |
| OG001 | Reference Product | Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water. |
|
|
|
| Secondary | Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 2 Hours Post Acid Challenge. | The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography. The Images were graded as follows:
| The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation were excluded from PP analyses. The primary population was the PP population. | Posted | Median | Full Range | Scores on grading scale | Baseline, 2 hours post acid challenge |
|
|
|
|
| Secondary | Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 4 Hours Post Acid Challenge | The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography. The Images were graded as follows:
| The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation were excluded from PP analyses. The primary population was the PP population. | Posted | Median | Full Range | Scores on grading scale | Baseline, 4 hours post acid challenge |
|
|
|
|
| Secondary | Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 7 Hours Post Acid Challenge | The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography. The Images were graded as follows:
| The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation were excluded from PP analyses. The primary population was the PP population. | Posted | Median | Full Range | Scores on grading scale | Baseline, 7 hours post acid challenge |
|
|
|
|
| Secondary | Change From Baseline of Salivary Calcium Concentration at 30 Mins Post Dietary Acid Challenge | Saliva stored at 0 - 20°C was used for determining calcium concentration | The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation was excluded from PP analyses. The primary population was the PP population. | Posted | Mean | Standard Deviation | ppm | Baseline, 30 mins post dietary acid challenge |
|
|
|
|
| Secondary | Change From Baseline of Salivary Calcium Concentration 7 Hours Post Dietary Acid Challenge | Saliva stored at 0 - 20°C was used for determining calcium concentration | The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation was excluded from PP analyses. The primary population was the PP population. | Posted | Mean | Standard Deviation | ppm | Baseline, 7 hours post dietary acid challenge |
|
|
|
|
| Secondary | Change From Baseline of pH Measurement at 30 Mins Post Dietary Acid Challenge | Saliva stored at 0 - 20°C was used for determining pH | The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation was excluded from PP analyses. The primary population was the PP population | Posted | Mean | Standard Deviation | pH units | Baseline, 30 mins post dietary acid challenge |
|
|
|
|
| Secondary | Change From Baseline of pH Measurement 7 Hours Post Dietary Acid Challenge | Saliva stored at 0 - 20°C was used for determining pH | The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation was excluded from PP analyses. The primary population was the PP population | Posted | Mean | Standard Deviation | pH units | Baseline, 7 hours post dietary acid challenge |
|
|
|
|
| Secondary | Change From Baseline in Buffering Capacity at 30 Mins Post Dietary Acid Challenge | Saliva was collected and stored at 0 - 20°C. A Saliva-check Buffer Kit was used to determine the buffer capacity. The colourimetric assay yielded a coloured pattern on a paper diagnostic using a 0-12 scale where 0-5 was deemed to be very low, 6-9 was deemed low and 10-12 was deemed normal-high. | The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation was excluded from PP analyses. The primary population was the PP population. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, 30 mins post dietary acid challenge |
|
|
|
|
| Secondary | Change From Baseline in Buffering Capacity 7 Hours Post Dietary Acid Challenge | Saliva was collected and stored at 0 - 20°C. A Saliva-check Buffer Kit was used to determine the buffer capacity. The colourimetric assay yielded a coloured pattern on a paper diagnostic using a 0-12 scale where 0-5 was deemed to be very low, 6-9 was deemed low and 10-12 was deemed normal-high. | The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation was excluded from PP analyses. The primary population was the PP population. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, 7 hours post dietary acid challenge |
|
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Reference Product | Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water. | 0 | 14 | 0 | 14 |
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.
| D017670 |
| Sodium Compounds |
| D002327 | Cariostatic Agents |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |