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| Name | Class |
|---|---|
| Indiana University | OTHER |
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Double-blind, randomized, 3 group in situ study to assess effect of three toothpastes on enamel remineralization, as measured by change in integrated mineral loss (∆∆Z). The study will examine the efficacy of an experimental sodium monofluorophosphate (SMFP) toothpaste, a standard SMFP toothpaste and a negative control toothpaste with no fluoride.
Double-blind, randomized, 3 group, in situ enamel remineralisation study. This study will accept up to 60 adult subjects who meet the inclusion/exclusion criteria in anticipation that at least 50 subjects will complete the study. All 60 subjects will have two human enamel specimens (one enamel specimen type C and one enamel specimen type N) placed in their partial denture for analysis by transverse microradiography (TMR) and of those sixty subjects, a subset will have an additional two enamel specimens (type N) placed in their partial denture for TMR measurement. All enamel specimens will have been partially demineralized using lactic acid in the laboratory prior to placement in subjects' dentures.
Subjects will receive a dental prophylaxis at the start of the trial and then brush their teeth with a fluoride-free toothpaste for the following 2 to 3 days. For the washout phase between each crossover period, subjects will return to brushing with their regular toothpaste for 4 to 5 days and then receive a dental prophylaxis and brush their teeth with a fluoride-free toothpaste for the 2 to 3 days before the next test period.
During each test period, subjects will be asked to brush with their allocated toothpaste at home twice daily for 4 weeks taking care to not brush the enamel specimens. The brushing procedure will be performed at home each morning following breakfast and right before going to bed on each evening. Subjects must wear their partial denture for 24 hours a day during the test phase.
At final visit of each test period, subjects will be instructed to brush their teeth with the randomly assigned trial toothpaste. Enamel specimens will be removed from denture and transferred to analyst for laboratory analyses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental SMFP Toothpaste | Experimental | Toothpaste containing 1450ppm SMFP with additional calcium and phosphate |
|
| SMFP Toothpaste | Active Comparator | Toothpaste containing 1450ppm SMFP |
|
| Negative control toothpaste | Placebo Comparator | Toothpaste with no fluoride |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental Toothpaste containing 1450ppm SMFP | Other | Experimental Toothpaste containing 1450ppm SMFP |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in integrated mineral loss from baseline ∆∆Z (enamel specimen type N) | Calculation of Integrated Mineral Loss ∆Z = [(lesion depth x 87) - area under the curve] where 'area under the curve' relates volume % mineral at distances from the enamel specimen surface with respect to enamel section thickness, measured using transverse microradiography (TMR) | Baseline to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in integrated mineral loss ∆∆Z (enamel specimen type C) | Calculation of Integrated Mineral Loss ∆Z = [(lesion depth x 87) - area under the curve] where 'area under the curve' relates volume % mineral at distances from the enamel specimen surface with respect to enamel section thickness, measured using transverse microradiography (TMR) | Baseline to 4 weeks |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Domenick T Zero, DDS, MS | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oral Health Research Institute, Indiana University | Indianapolis | Indiana | 46202-2876 | United States |
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| ID | Term |
|---|---|
| D014100 | Toothpastes |
| ID | Term |
|---|---|
| D003802 | Dentifrices |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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| Toothpaste containing 1450ppm SMFP | Other | Toothpaste containing 1450ppm SMFP |
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| Toothpaste with no fluoride | Other | Toothpaste with no fluoride |
|