Fluoride Delivery to Prevent White Spots During Orthodontic Treatment (NCT05005689) | Clinical Trial Compass
UnknownPhase 4
Fluoride Delivery to Prevent White Spots During Orthodontic Treatment
United Kingdom130 participantsStarted 2023-10-20
Plain-language summary
The aim of this 2-armed, parallel, randomised, controlled trial is to assess the effect of different ways of applying fluoride to teeth on the formation of white spots (enamel demineralisation), during orthodontic treatment with fixed metal braces, in children and adolescents.
Who can participate
Age range11 Years – 16 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Planned to receive orthodontic treatment with upper and lower fixed orthodontic appliances (braces) either alone or following a period of functional appliance treatment.
* 11-16 years of age inclusive at the start of the fixed orthodontic appliance treatment.
* All genders.
* Fit and well with no chronic disease necessitating regular hospital follow-up at hospital.
* Willing to participate
Exclusion Criteria:
* Significant disabilities that may affect manual dexterity;
* Any medical complication that would contraindicate the use of the fluoride treatments or milk products;
* Previous orthodontic treatment except Phase I functional appliance treatment;
* From areas that have fluoridated water supply\*;
* Full coronal coverage restorations;
* More than 2 missing anterior teeth;
* Showing signs of systemic illness e.g. fever, cough, loss of taste/smell;
* Any abnormality of face, lips e.g. cleft lip and/or palate or craniofacial abnormality or soft tissues of the mouth e.g. aphthous ulcers or connective tissue disorder.
What they're measuring
1
New white spot lesions (WSLs)
Timeframe: Through to study completion, an average of 2 years
Trial details
NCT IDNCT05005689
SponsorLiverpool University Hospitals NHS Foundation Trust