Total Salivary Fluoride Concentration of Healthy Adult Subjects Following Toothbrushing With Different Formulations of Fluoridated Toothpastes With and Without Post-brushing Water Rinsing.
1 other identifier
interventional
120
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2016
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedFirst Posted
Study publicly available on registry
April 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2017
CompletedJune 6, 2017
June 1, 2017
1.2 years
February 24, 2016
June 4, 2017
Conditions
Outcome Measures
Primary Outcomes (6)
Salivary fluoride concentration following brushing with different toothpaste formulations.
Prior brushing
0 minutes
Salivary fluoride concentration following brushing with different toothpaste formulations.
1 minutes postbrushing
1 minutes
Salivary fluoride concentration following brushing with different toothpaste formulations.
15 minutes postbrushing
15 minutes
Salivary fluoride concentration following brushing with different toothpaste formulations.
30 minutes postbrushing
30 minutes
Salivary fluoride concentration following brushing with different toothpaste formulations.
60 minutes postbrushing
60 minutes
Salivary fluoride concentration following brushing with different toothpaste formulations.
90 minutes postbrushing
90 minutes
Secondary Outcomes (6)
Salivary fluoride concentration following brushing with different toothpaste formulations - with and without water rinsing
0 minutes
Salivary fluoride concentration following brushing with different toothpaste formulations - with and without water rinsing
1 minutes
Salivary fluoride concentration following brushing with different toothpaste formulations - with and without water rinsing
15 minutes
Salivary fluoride concentration following brushing with different toothpaste formulations - with and without water rinsing
30 minutes
Salivary fluoride concentration following brushing with different toothpaste formulations - with and without water rinsing
60 minutes
- +1 more secondary outcomes
Study Arms (12)
NaF - R
EXPERIMENTALParticipants will use sodium fluoride toothpaste (1,450 ppmF) to brush for two minutes followed by rinsing with distilled water.
NaF - NR
EXPERIMENTALParticipants will use sodium fluoride toothpaste (1,450 ppmF) to brush for two minutes not followed by rinsing with distilled water.
NaMFP- R
EXPERIMENTALParticipants will use sodium monofluorophosphate toothpaste (1,450 ppmF) to brush for two minutes followed by rinsing with distilled water.
NaMFP- NR
EXPERIMENTALParticipants will use sodium monofluorophosphate toothpaste (1,450 ppmF) to brush for two minutes not followed by rinsing with distilled water.
SnF + NaF - R
EXPERIMENTALParticipants will use stannous fluoride combined with sodium fluoride toothpaste (1,450 ppmF) to brush for two minutes followed by rinsing with distilled water.
SnF + NaF - NR
EXPERIMENTALParticipants will use stannous fluoride combined with sodium fluoride toothpaste (1,450 ppmF) to brush for two minutes not followed by rinsing with distilled water.
NaF + NaMFP - R
EXPERIMENTALParticipants will use sodium fluoride combined sodium monofluorophosphate toothpaste (1,450 ppmF) to brush for two minutes followed by rinsing with distilled water.
NaF + NaMFP - NR
EXPERIMENTALParticipants will use sodium fluoride combined sodium monofluorophosphate toothpaste (1,450 ppmF) to brush for two minutes not followed by rinsing with distilled water.
AmF - R
EXPERIMENTALParticipants will use amine fluoride toothpaste (1,400 ppmF) to brush for two minutes followed by rinsing with distilled water.
AmF - NR
EXPERIMENTALParticipants will use amine fluoride toothpaste (1,400 ppmF) to brush for two minutes not followed by rinsing with distilled water.
0 Fluoride - R
EXPERIMENTALParticipants will use non-fluoridated toothpaste (0 ppmF) to brush for two minutes followed by rinsing with distilled water.
0 Fluoride - NR
EXPERIMENTALParticipants will use non-fluoridated toothpaste (0 ppmF) to brush for two minutes not followed by rinsing with distilled water.
Interventions
Eligibility Criteria
You may qualify if:
- Participants in this study should be ASA\* I and ASA\* II adult volunteers.
- Salivary flow rate of 0.1 ml / minute or more.
- Caries-free and non-caries free are to be included.
- ASA stands for American society of Anesthesiologists grading system
You may not qualify if:
- Edentulous patients.
- Participants who are ASA\* III or higher will be excluded.
- Allergy to any of the materials used in the study.
- Participants with orthodontic devices / braces.
- Participants with salivary flow rate of or below 0.1 ml / minute.
- Participants who are incapable of fasting for 4 hours.
- Participants who refuse to use fluoride-free toothpaste, or those who would want to have control over which toothpaste to use.
- Participants who cannot retain toothpaste and have to rinse after tooth brushing (ie. gagging due to toothpaste taste).
- ASA stands for American society of Anesthesiologists grading system
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Leeds Dental Institute
Leeds, West Yorkshire, LS2 9LU, United Kingdom
Related Publications (1)
Albahrani MM, Alyahya A, Qudeimat MA, Toumba KJ. Salivary fluoride concentration following toothbrushing with and without rinsing: a randomised controlled trial. BMC Oral Health. 2022 Mar 3;22(1):53. doi: 10.1186/s12903-022-02086-5.
PMID: 35241051DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Post-graduate Professional Doctorate of Paediatric Dentistry
Study Record Dates
First Submitted
February 24, 2016
First Posted
April 15, 2016
Study Start
April 1, 2016
Primary Completion
May 31, 2017
Study Completion
May 31, 2017
Last Updated
June 6, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will share
Participants will be informed that data will be anonymised so that they cannot be identified even in case of results dissemination (i.e peer-reviewed journals. Age, gender, sex, salivary rate per minutes, fluoride ion concentrations in saliva prior to brushing and post-brushing at 1, 15, 30, 60 and 90 minutes.