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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mouthwash | Active Comparator | Fluoride mouthwash (0.05%; 225ppm) 10ml for 1 minute daily |
|
| Tooth Mousse | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoride mouthwash (0.05%; 225ppm). | Drug | Mouthwash |
|
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jayne E Harrison, FDS, PhD | Contact | 441517065030 | Jayne.Harrison@liverpoolft.nhs.uk | |
| Norah L Flannigan, FDS, PhD | Contact | 441517065210 | NLF@liverpool.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Heather Rogers | Liverpool University Hospitals NHS Foundation Trust | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liverpool University Hospitals NHS Foundation Trust | Recruiting | Liverpool | Merseyside | L9 7AL | United Kingdom |
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| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D012969 | Sodium Fluoride |
| C447032 | casein phosphopeptide-amorphous calcium phosphate nanocomplex |
| ID | Term |
|---|---|
| D005459 | Fluorides |
| D006858 | Hydrofluoric Acid |
| D017611 | Fluorine Compounds |
| D007287 | Inorganic Chemicals |
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| Tooth Mousse Plus | Drug | Tooth Mousse |
|
|
| 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 |
| D017670 |
| Sodium Compounds |
| D002327 | Cariostatic Agents |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |