Fluoride delivery to prevent white spots during orthodontic treatment
Research type
Research Study
Full title
A 2-armed, parallel, randomised controlled trial to assess the effect of different modes of fluoride delivery, on enamel demineralisation, during orthodontic treatment with fixed appliances, in children and adolescents.
IRAS ID
254656
Contact name
Jayne Harrison
Contact email
Sponsor organisation
Liverpool University Hospitals NHS Foundation Trust
Eudract number
2018-004335-76
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 5 months, 30 days
Research summary
One of the most common side-effects and risks dental brace treatment is damage to the outer surface (enamel) of the teeth. This damage can take the form of white or brown spots on the teeth (WSLs.) If severe, holes in the teeth can form that will need a filling.
The aims of this study are to find out the best way of preventing damage to children's teeth who are having dental brace (orthodontic) treatment with fixed (metal) braces.
There will be 130 children, aged 11-16 years old, in the study. They will be split into two groups using a process like tossing a coin. This will decide which treatment they are going to have
The treatments will be normal fluoride toothpaste (Colgate) plus either:
1) Fluoride mouth wash (Fluorigard) or
2) Tooth Mousse Plus toothpaste
The children will be seen to check their teeth and adjust their brace, every 6-weeks. Photos will be taken of their teeth every 3 months. These will show us if any of the teeth have been damaged.
The children will be in the study until their treatment is finished. This will take about 2 years.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
22/NW/0092
Date of REC Opinion
26 May 2022
REC opinion
Further Information Favourable Opinion