Salivary fluoride using different toothpaste formulations
Research type
Research Study
Full title
Total Salivary Fluoride Concentration of Healthy Adult Subjects Following Toothburshing with different Formulations of Fluoridated Toothpastes With and Without Post-brushing water rinsing.\nA randomised controlled Trial
IRAS ID
190951
Contact name
M Albahrani
Contact email
Sponsor organisation
Unviersity of Leeds
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 1 months, 0 days
Research summary
This is a double-blinded randomised controlled trial that aims to measure the salivary fluoride concentration following tooth-brushing with several toothpaste formulations. Power calculations were performed using PASS 11.0 software, and calculations showed that at least 3 participants are needed in each group in order for results to be considered as significant. We will aim to recruit five participants in each of the 12 groups. Research will be publicised by means of flyers and circulating emails amongst University of Leeds students. Information sheets will be provided to all participants and informed consent will be obtained.\nEach participant will brush with one of 6 different formulations of toothpastes either with or without water rinsing post-brushing. Participants will randomly be assigned to groups using an online random team generator. Saliva will be collected six times once before brushing and at 1, 15, 30, 60 and 90 minutes post-brushing. Samples will be analysed using fluoride ion-specific sensitive electrode connected to an ion analyser. \nA statistician’s help will be sought for analysis of the results. After analysis stage, the codes of the toothpastes will be broken.\n
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
16/YH/0015
Date of REC Opinion
12 Feb 2016
REC opinion
Favourable Opinion