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This study is a double-blind, randomised, parallel group efficacy study. A minimum of 240 healthy female and male participants aged over 18 years will participate. The participants will be randomised into two groups. Participants will be randomly assigned 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 cleaned using a professional prophylaxis polish by the study hygienist. 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 |
|---|---|---|---|
| Fluoride Toothpaste 1 | Experimental | Toothpaste containing Sodium Fluoride at 1450 ppm F |
|
| Fluoride Toothpaste 2 | Active Comparator | Toothpaste containing Sodium Fluoride at 1450 ppm F |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoride Toothpaste 1 | Other | Toothpaste containing 1450 ppm F as Sodium Fluoride |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in gingival condition as measured by the Modified Lobene Gingival Index | 13 weeks | |
| Change in gingival condition as measured by the Saxton van der Ouderaa bleeding index | 13 weeks | |
| Change in plaque levels as measure by the Quigley and Hein Plaque index | 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| change in gingival condition as measured by the Modified Lobene Gingival Index | 26 weeks | |
| change in gingival condition as measured by the Saxton 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, Professor | University of Bristol | Principal Investigator |
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| ID | Term |
|---|---|
| D005882 | Gingival Diseases |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| Fluoride Toothpaste 2 | Other | Toothpaste containing 1450 ppm F as Sodium Fluoride |
|
|
| Change in plaque levels as measured by the Quigley and Hein plaque index |
| 26 weeks |