Clinical trial Recruiting at 1 site Interventional Ages 12 to 21

Comparing two treatments for white spot lesions after braces

Official title: Comparison of MI Paste Plus and Resin Infiltration in Improvement of White Spot Lesions Following Fixed Orthodontic Treatment: A Randomized Controlled Trial

Run by University of Alberta · NCT05733676 · Data updated 2026-11-12

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

Study typeInterventional
Ages12 Years to 21 Years
SexAll
Enrollment62 (estimated)
SponsorUniversity of Alberta
Academic / other
Locations1 site (Edmonton, Alberta)
StatusRecruiting
StartedMay 30, 2023
Main results expectedMarch 1, 2028
Study endsOctober 1, 2028
Registry record updatedJune 30, 2026
Trial IDNCT05733676 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.