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 range
11 Years – 16 Years
Sex
ALL
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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