Fluoride Delivery to Prevent White Spots During Orthodontic Treatment

• Status: Not yet recruiting
• Trial end date: 2025-09-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Liverpool University Hospitals NHS Foundation Trust
• Treatments: Fluorides; Sodium Fluoride

Criteria

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.