Preventing white spots on teeth 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
This study is testing whether different fluoride treatments can help prevent white spots on the teeth of kids and teens wearing braces.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 11 Years to 16 Years |
| Sex | All |
| Sponsor | Liverpool University Hospitals NHS Foundation Trust Government |
| Locations | 1 site (Liverpool, Merseyside) |
| Trial ID | NCT05005689 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of different fluoride application methods in preventing enamel demineralization, specifically white spot lesions, in children and adolescents undergoing orthodontic treatment with fixed metal braces. The study involves 130 participants aged 11-16, who will be randomly assigned to receive either standard fluoride toothpaste combined with fluoride mouthwash or Tooth Mousse Plus. Participants' teeth will be monitored throughout the two-year treatment period, with regular check-ups and photographic documentation to assess any enamel damage. Additionally, the impact of white spots on participants' quality of life will be evaluated through surveys.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 11-16 who are about to begin orthodontic treatment with fixed braces.
Not a fit: Patients with significant disabilities affecting manual dexterity or those with contraindications to fluoride treatments will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of white spot lesions in young patients undergoing orthodontic treatment.
How similar studies have performed: Previous studies have shown varying success in using fluoride treatments to prevent enamel demineralization during orthodontic treatment, making this approach both relevant and promising.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Liverpool, Merseyside
- Liverpool University Hospitals NHS Foundation Trust — Liverpool, Merseyside, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Jayne E Harrison, FDS, PhD
- Email: Jayne.Harrison@liverpoolft.nhs.uk
- Phone: 441517065030
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.