Healthy Clinical Trial
Official title:
A Study to Measure the Effect of a Toothpaste Containing Zinc Citrate Trihydrate Used in Combination With a Serum Containing Zinc Sulphate Heptahydrate and a Standard Fluoride Toothpaste on Gingival Health Over a Six Month Period.
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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