Fluoride Delivery to Prevent White Spots During Orthodontic Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-20

Study Completion Date

2025-09-30

Brief Summary

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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.

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Detailed Description

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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

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Orthodontic Appliance Complication Tooth Demineralization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Mouthwash

Fluoride mouthwash (0.05%; 225ppm) 10ml for 1 minute daily

Group Type ACTIVE_COMPARATOR

Fluoride mouthwash (0.05%; 225ppm).

Intervention Type DRUG

Mouthwash

Tooth Mousse

Tooth Mousse Plus (Recaldent™ CPP-ACP \[casein phosphopeptide (CPP)-amorphous calcium phosphate (ACP)\] and Sodium Fluoride 0.2% w/w; 900 ppm).

Tooth creme; 2ml smear daily

Group Type EXPERIMENTAL

Tooth Mousse Plus

Intervention Type DRUG

Tooth Mousse

Interventions

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Fluoride mouthwash (0.05%; 225ppm).

Mouthwash

Intervention Type DRUG

Tooth Mousse Plus

Tooth Mousse

Intervention Type DRUG

Other Intervention Names

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Fluorigard Recaldent™ CPP-ACP [casein phosphopeptide (CPP)-amorphous calcium phosphate (ACP)] and Sodium Fluoride 0.2% w/w (900 ppm).

Eligibility Criteria

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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.

Minimum Eligible Age

11 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No