A Randomised, Controlled Trial to Assess the Effect of Different Modes of Fluoride Delivery on Enamel Demineralisation, During Orthodontic Treatment With Fixed Appliances
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- New white spot lesions (WSLs)
Study Overview
Brief 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:
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 11 Years to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Mouthwash
Fluoride mouthwash (0.05%; 225ppm) 10ml for 1 minute daily
Intervention: Fluoride mouthwash (0.05%; 225ppm). (Drug)
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
Intervention: Tooth Mousse Plus (Drug)
Outcomes
Primary Outcomes
New white spot lesions (WSLs)
Time Frame: Through to study completion, an average of 2 years
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.
Secondary Outcomes
- Participants' perception of WSL(Through to study completion, an average of 2 years)
- Parents' perception of WSL(Through to study completion, an average of 2 years)
- Extent of white spot lesion (WSL)(Through to study completion, an average of 2 years)
- Size of white spot lesion (WSL)(Through to study completion, an average of 2 years)
- MIQ Score(Through to study completion, an average of 2 years)