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| Name | Class |
|---|---|
| University of Bristol Dental Hospital | OTHER |
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This study is a double-blind, randomised, parallel group efficacy study. Up to 240 healthy female and male participants aged over 18 years will participate. There will be two groups of up to 120 participants. Participants will be randomised to the test groups according the allocation table prepared by the Statistician.
Participants will be enrolled on to the study according to the inclusion/exclusion criteria. After enrollment participants will have their teeth that have been allocated for assessment cleaned using a professional prophylaxis polish by the study dentist. The participants will then be provided with a standard cosmetic silica Fluoride toothpaste and a toothbrush to use at home, twice a day for up to four weeks. After this time they will return to the test site and have the baseline dental assessments. Participants will then be randomly allocated to one of the two test products which they will use at home, twice a day for the duration of the study. Dental assessments will be conducted after 13 and 26 weeks of product use at the study site.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Other | Toothpaste containing 1.11% Fluoride as Sodium Monofluorophosphate and Zinc Citrate Trihydrate Serum containing 0.17% Fluoride as Sodium Monofluorophosphate and Zinc Sulphate Heptahydrate |
|
| Comparator | Other | Silica toothpaste 1350ppm F as Sodium Fluoride |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment | Other | F13/T38 |
| |
| Comparator |
| Measure | Description | Time Frame |
|---|---|---|
| Change in gingival condition as assessed using the Modified Lobene Gingival Index | 13 weeks | |
| Change in gingival condition as assessed using the Saxton and van der Ouderaa bleeding index | 13 weeks | |
| Change in gingival condition as assessed using the Modified Quigley and Hein plaque index | 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in gingival condition as assessed using the Modified Lobene Gingival Index | 26 weeks | |
| Change in gingival condition as assessed using the Saxton and van der Ouderaa bleeding index | 26 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicola X West, BDS | Bristol Dental Hospital and School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bristol Dental Hospital and School | Bristol | BS1 2LY | United Kingdom |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Other |
M26 |
|
| Change in gingival condition as assessed using the Modified Quigley and Hein plaque index | 26 weeks |