NCT05005689

Fluoride Delivery to Prevent White Spots During Orthodontic Treatment

A Randomised, Controlled Trial to Assess the Effect of Different Modes of Fluoride Delivery on Enamel Demineralisation, During Orthodontic Treatment With Fixed Appliances

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Liverpool University Hospitals NHS Foundation Trust · Other Government
• Sex: All
• Age: 11 Years – 16 Years
• Healthy volunteers: Not accepted

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.

Detailed description

One of the most common side-effects and risks of orthodontic treatment with fixed (metal) braces is damage to the outer surface (enamel) of the teeth. This damage can take the form of white or brown spots on the teeth (white spot lesions; WSLs) or if severe, holes in the teeth that need a filling. The aims of this study are to find out the best way of preventing damage to the teeth of children and adolescents who are under going orthodontic treatment with fixed (metal) braces. The participants will be 130 children, aged 11-16 years old, inclusive. The participants will be split into two groups using a process called randomisation. The treatments will be standard fluoride toothpaste (Colgate) and either: 1. Fluoride mouth wash (Fluorigard) or 2. Tooth Mousse Plus The participants' teeth will be checked at every visit and the brace adjusted. Photographs of the participants' teeth will be taken very 3 months to see if any of the teeth have been damaged. The participants will be asked about the impact of their teeth on their life. Participants and parents will be asked about the impact of any white spots that form on the participants' teeth during the treatment with fixed (metal) braces. The study will follow the participants through the whole length of treatment which will take about 2 years.

Conditions

• Orthodontic Appliance Complication
• Tooth Demineralization

Interventions

Type	Name	Description
DRUG	Fluoride mouthwash (0.05%; 225ppm).	Mouthwash
DRUG	Tooth Mousse Plus	Tooth Mousse

Timeline

• Start date: 2023-10-20
• Primary completion: 2025-09-30
• Completion: 2025-09-30
• First posted: 2021-08-13
• Last updated: 2023-11-08

Locations

1 site across 1 country: United Kingdom