Total Salivary Fluoride Concentration of Healthy Adult Subjects Following Toothbrushing With Different Formulations of Fluoridated Toothpastes With and Without Post-brushing Water Rinsing. A Double Blinded Randomised Controlled Trial

Caries prevalence has declined significantly since the introduction of fluoridated toothpastes. Since then, different toothpaste formulations and concentrations have been introduced to the market with varying levels of efficacy. There are several commercially available toothpastes to choose from and only with the aid of sound methodological research, can the best evidence-based oral education advice be delivered.

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 3 participants are needed in each group in order for results to be considered as significant. We will aim to recruit five to seven 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.

Each 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.

A statistician's help will be sought for analysis of the results. After the analysis stage, the codes of the toothpastes will be broken.