Comparing two treatments for white spot lesions after braces
Comparison of MI Paste Plus and Resin Infiltration in Improvement of White Spot Lesions Following Fixed Orthodontic Treatment: A Randomized Controlled Trial
This study is testing whether MI Paste Plus or resin infiltration works better to treat white spot lesions on teeth in young people who have just had their braces removed.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 12 Years to 21 Years |
| Sex | All |
| Sponsor | University of Alberta Academic / other |
| Locations | 1 site (Edmonton, Alberta) |
| Trial ID | NCT05733676 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of MI Paste Plus and resin infiltration in treating white spot lesions (WSLs) that often occur after orthodontic treatment. WSLs are early signs of tooth decay that appear as milky-white opacities on teeth, particularly in patients who have worn braces. The study will involve individuals aged 12-21 who have at least one visible WSL after orthodontic debonding, and it will assess the outcomes of the two treatment methods in promoting remineralization and preventing further decay. Participants will be monitored for changes in the appearance and health of their lesions following treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 12-21 who have undergone fixed orthodontic treatment and have at least one white spot lesion on their anterior teeth.
Not a fit: Patients with poor oral hygiene or those who have developmental defects or prior restorations on their incisors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for managing white spot lesions, improving both dental aesthetics and oral health for patients post-orthodontics.
How similar studies have performed: While there have been some in vitro studies on remineralization products, this clinical comparison of MI Paste Plus and resin infiltration is relatively novel and has not been extensively tested in vivo.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals in the age range of 12-21 years who had undergone fixed orthodontic appliance therapy for a duration of 12-36 months. * Should have at least one white spot lesion on the labial surface of either maxillary or mandibular anterior teeth after debonding. Lesion visible with or without drying the lesion surface. * Patients with mild to moderate plaque accumulation. Fair oral hygiene. With a simplified Oral Hygiene Index of no more than 1.3-3.0 Exclusion Criteria: * Poor oral hygiene Simplified Oral Hygiene Index of 3.1-6.0 or more * Patients with hypoplasia or any developmental defects on the buccal of upper or lower incisors * Patients with any restorations on the buccal of upper or lower incisors * Patients that have presented WSL on the buccal of upper or lower incisors before orthodontic treatment was initiated. * Patients that have received any re-mineralizing agent other than regular toothpaste during the last three months * Patient with allergy to milk or any of their products * Patient with any medical / oral or mental condition * Patients or legal guardians that does not speak or read English
Where this trial is running
Edmonton, Alberta
- KAYE Edmonton Clinic — Edmonton, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Ida M Kornerup, DMD, MEd — University of Alberta
- Study coordinator: Ida M Kornerup, DMD, MEd
- Email: kornerup@ualberta.ca
- Phone: 780 492 7100
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.