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This study was cancelled. No subjects were enrolled and no data has been collected
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The purpose of this study is to evaluate the effect of the test toothpaste containing 1150 parts per million (ppm) of fluoride (F) on the mineral content of demineralized enamel specimens, in an in situ caries model system, by comparing the differences in net remineralization change (ΔM) following use of the test toothpaste with a fluoride free (0 ppm F) reference control toothpaste.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test fluoride toothpaste | Experimental | Participants will apply 1.5 weighed g (± 0.1 g) of the study toothpaste to a wet toothbrush and brush their natural teeth twice daily for one timed minute. Participants will wear their mandibular partial denture with test specimens while brushing and continuously for 24 hours a day during each of the 4-week treatment periods |
|
| Fluoride free (0ppm F) reference control toothpaste | Placebo Comparator | Participants will apply 1.5 weighed g (± 0.1 g) of the study toothpaste to a wet toothbrush and brush their natural teeth twice daily for one timed minute. Participants will wear their mandibular partial denture with test specimens while brushing and continuously for 24 hours a day during each of the 4-week treatment periods. |
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| Low dose fluoride (250ppm F) reference control toothpaste | Active Comparator | Participants will apply 1.5 weighed g (± 0.1 g) of the study toothpaste to a wet toothbrush and brush their natural teeth twice daily for one timed minute. Participants will wear their mandibular partial denture with test specimens while brushing and continuously for 24 hours a day during each of the 4-week treatment periods. |
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| Fluoride (1150ppm F) reference control toothpaste | Active Comparator | Participants will apply 1.5 weighed g (± 0.1 g) of the study toothpaste to a wet toothbrush and brush their natural teeth twice daily for one timed minute. Participants will wear their mandibular partial denture with test specimens while brushing and continuously for 24 hours a day during each of the 4-week treatment periods. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toothpaste containing 1150ppm F | Drug | US marketed toothpaste containing 1150ppm of F |
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| Measure | Description | Time Frame |
|---|---|---|
| Net remineralization change (ΔM) of demineralised enamel specimens following use of the test toothpaste with a fluoride free reference control toothpaste | The change in mineral content (ΔM) of the lesions as measured by Transverse Microradiography (TMR) will be calculated by the following formula: ΔM= (Post-treatment ΔZ - baseline ΔZ) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Net remineralization change (ΔM) of demineralised enamel specimens following use of the test toothpaste with all other treatments | The change in mineral content (ΔM) of the lesions as measured by TMR will be calculated by the following formula: ΔM= (Post-treatment ΔZ - baseline ΔZ) | 4 weeks |
| Changes in enamel lesion depth (ΔL) following use of the test toothpaste with all other treatments |
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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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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| Toothpaste containing 0ppm F | Other | Experimental toothpaste containing 0ppm F |
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| Toothpaste containing 250ppm F | Drug | Experimental toothpaste containing 250ppm F |
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| Toothpaste containing 1150ppm F | Drug | Experimental toothpaste containing 1150ppm F |
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The change in lesion depth (ΔL) as measured by TMR will be calculated by: ΔL= (Post-treatment lesion depth - baseline lesion depth) |
| 4 weeks |
| Net change in surface zone mineral content (ΔSZmax) following use of the toothpaste with all other treatments | The change in SZmax (ΔSZmax) as measured by TMR will be calculated by: ΔSZmax= (Post-treatment SZmax - baseline SZmax) | 4 weeks |