A study to assess gum health after 26 weeks toothpaste use.
Research type
Research Study
Full title
A cosmetic study to measure the effect of a toothpaste containing proteins and enzymes and a fluoride toothpaste on gingival health over a six month period. ORL-GUM-2544
IRAS ID
210498
Contact name
Nicola West
Contact email
Sponsor organisation
Research and Enterprise Development, University of Bristol
Duration of Study in the UK
0 years, 7 months, 3 days
Research summary
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 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.REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
16/SW/0190
Date of REC Opinion
17 Aug 2016
REC opinion
Further Information Favourable Opinion