Fluoride Delivery to Prevent White Spots During Orthodontic Treatment

Study Overview
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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.

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: Fluoride mouth wash (Fluorigard) or 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.

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

Conditions
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Orthodontic Appliance Complication, Tooth Demineralization

Intervention / Treatment
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* Drug: Fluoride mouthwash (0.05%; 225ppm).
* Drug: Tooth Mousse Plus


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mouthwash<br>Fluoride mouthwash (0.05%; 225ppm) 10ml for 1 minute daily | Drug: Fluoride mouthwash (0.05%; 225ppm).<br>* Mouthwash<br>* Other names: Fluorigard;|
| Experimental: Tooth Mousse<br>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 | Drug: Tooth Mousse Plus<br>* Tooth Mousse<br>* Other names: Recaldent™ CPP-ACP [casein phosphopeptide (CPP)-amorphous calcium phosphate (ACP)] and Sodium Fluoride 0.2% w/w (900 ppm).;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New white spot lesions (WSLs) | The incidence of new demineralisation (WSLs), developing on the anterior teeth during fixed orthodontic treatment assessed from white light and quantitative light-induced fluorescence (QLF) images, will be measured. Numerical scale 0 - unlikely to be more than 100. Higher score is worse. | Through to study completion, an average of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Size of white spot lesion (WSL) | The degree (∆F) of enamel demineralisation on the surfaces of the anterior teeth measure from quantitative light-induced fluorescence (QLF) images. Measured as a percentage (%) compared to baseline i.e. loss of mineral. Scale ∆F 0% to -100%; Higher score is worse. | Through to study completion, an average of 2 years | 
| Extent of white spot lesion (WSL) | The extent (∆Q) of enamel demineralisation on the surfaces of the anterior teeth. measure from quantitative light-induced fluorescence (QLF) images. Measured as a percentage per millimetre squared (%mm-2) compared to baseline i.e. loss of mineral. Scale ∆Q 0% to -100%mm-2. Higher score is worse. | Through to study completion, an average of 2 years | 
| Participants' perception of WSL | Participants' perception of the WSLs. Measured on 100mm visual analogue scale (VAS). Scale 0 to 100. Higher score is worse. | Through to study completion, an average of 2 years | 
| Parents' perception of WSL | Parents' perception of the WSLs. Measured on 100mm visual analogue scale (VAS). Scale 0 to 100. Higher score is worse. | Through to study completion, an average of 2 years | 
| MIQ Score | Malocclusion Impact Questionnaire (MIQ) score. Measured using a 17-item questionnaire. Total score will be used where minimum score is 0 and maximum score is 34; higher score indicates poorer oral health related quality of life (OHRQoL). | Through to study completion, an average of 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fluoride, CPP-ACP