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Total Salivary Fluoride Concentration of Healthy Adult Subjects Following Toothbrushing With Different Formulations of Fluoridated Toothpastes With and Without Post-brushing Water Rinsing.

NCT02740803 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2017-06-06

No results posted yet for this study

Summary

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.

Conditions

  • Caries

Interventions

OTHER

Sodium fluoride toothpaste 1,450 ppmF

OTHER

sodium monofluorophosphate toothpaste 1,450 ppmF

OTHER

stannous fluoride combined with sodium fluoride toothpaste 1,450 ppmF

OTHER

sodium fluoride combined sodium monofluorophosphate toothpaste 1,450 ppmF

OTHER

Amine fluoride toothpaste 1,400 ppmF

OTHER

Non-fluoridated toothpaste 0 ppmF

Sponsors & Collaborators

  • University of Leeds

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02740803 on ClinicalTrials.gov