Gingival Diseases Clinical Trial
Official title:
A Study to Measure the Effect of Two Fluoride Toothpastes on Gingival Health Over a Six Month Period
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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