Plain English Summary
Background and study aims
Young people undergo orthodontic treatment to improve the appearance of their teeth, smile and bite. It is therefore very sad to see so many of these teeth become harmed during brace treatment, leaving a permanent and visible mark, which becomes very easy to see after brace removal. Toothpaste is recommended and used daily and therefore remains a relatively easy method of improving the appearance of the teeth by lessening the visibility of these marks. Whilst traditional Fluoride containing toothpastes have been shown to have some beneficial effects, newer toothpastes which contain lower levels of fluoride but a greater potential to release this in a more gradual way, offer the possibility of greater improvements in reducing these defects in the teeth. We aim to assess how brushing your teeth with one of two different types of toothpaste can affect the appearance of the white spots defects, known as white spot lesions (WSL), that have developed on the teeth and become visible following the removal of your fixed brace.
Who can participate?
Adolescents [12-18 years], who have undergone a minimum of 12-months of fixed appliance treatment in both arches, with clinically identifiable WSL present on at least 1 of the maxillary and/or mandibular anterior teeth [first premolar to first premolar] at the time of removal of fixed orthodontic appliances.
What does the study involve?
Participants will be randomly allocated to receive intervention care (Bio-Min toothpaste) or standardised care (Conventional toothpaste), and will be assessed for the level of remineralisation at 1-, 3-, 6- and 9-months.
What are the possible benefits and risks of participating?
The benefits are that it will help us to better understand which toothpaste is more effective in improving the appearance of the white spot defects on the teeth. There are no expected risks to taking part in this study.
Where is the study run from?
Institute of Dentistry, Queen Mary, University of London (UK)
When is the study starting and how long is it expected to run for?
December 2019 to September 2022
Who is funding the study?
BioMin Technologies Limited (UK)
Who is the main contact?
Prof Ama Johal, firstname.lastname@example.org
The effectiveness of Bio-Min toothpaste in the management of white spot lesions: a randomized control trial
A fluoride containing bioactive glass toothpaste does not lead to a greater reduction in visible post-orthodontic WSL compared with a standard toothpaste.
Not provided at time of registration
Interventional single center randomized controlled trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Enamel White Spot Lesions [WSL]
Participants will be randomly assigned, using computer generated numbers, blindly to intervention care (Bio-Min toothpaste) or standardised care (Conventional toothpaste), and assessed for the level of remineralisation at 1-, 3-, 6- and 9-months.
Primary outcome measure
Remineralisation of WSL measured using the method described by Willmot et al.,  as % change from baseline at 1-, 3-, 6- and 9-month
Secondary outcome measures
Time interval for remineralisation measured using the method described by Willmot et al.,  at 1-, 3-, 6- and 9-months.
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. Age 12-18 years
2. Undergone a minimum of 12-months of fixed appliance treatment in both arches
3. Clinically identifiable WSL present on at least 1 of the maxillary and/or mandibular anterior teeth [first premolar to first premolar] at the time of removal of fixed orthodontic appliances
Target number of participants
Participant exclusion criteria
1. Undergone previous course of fixed appliance treatment
2. Pre-existing clinical evidence of either enamel structural defects, demineralised lesions or flourosis prior to commencement of treatment
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Queen Mary University of London
Institute of Dentistry Turner Street
BioMin Technologies Limited
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
It is intended that the results of the research would be presented at conferences or organising/ attending workshops. In addition, the results can be published in peer-review journal.
IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.
Intention to publish date
Participant level data
Basic results (scientific)