Using topical Povidone-Iodine to prevent white spots during orthodontic treatment
Efficacy and Safety of Topical 10% Povidone-Iodine in Preventing White Spots During Orthodontic Treatment
This study is testing if a special mouthwash can help prevent white spots on the teeth of kids and teens getting braces.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 10 Years to 17 Years |
| Sex | All |
| Sponsor | University of Washington Academic / other |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT06616207 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine the effectiveness of a 10% Povidone-Iodine solution in preventing the development of white spot lesions on the maxillary anterior teeth in healthy children and teens undergoing orthodontic treatment. Participants aged 10-17 will be randomly assigned to receive either the Povidone-Iodine treatment or a placebo, with assessments conducted over a one-year period. The study will evaluate both the efficacy in preventing white spots and the safety of the topical application. Key outcomes include the incidence of new white spot lesions and changes in gingival health as measured by established indices.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy children and teens aged 10-17 who are beginning orthodontic treatment and have at least four permanent anterior teeth.
Not a fit: Patients with allergies to iodine, chronic antibiotic use, thyroid disease, or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the occurrence of white spot lesions in patients undergoing orthodontic treatment, improving their oral health outcomes.
How similar studies have performed: While the use of Povidone-Iodine in dental applications is known, this specific approach to preventing white spots during orthodontic treatment is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Healthy children and teens (10-17 years old) * Transitional or permanent dentition of at least 4 permanent anterior teeth in each arch * Full fixed appliance orthodontic treatment is expected to last at least one year Exclusion Criteria: * Allergies to iodine * Chronic prophylactic use of antibiotics * Diagnosis of thyroid disease * Conditions that could impair routine oral hygiene procedures. * Pregnant at enrollment
Where this trial is running
Seattle, Washington
- University of Washington, School of Dentistry Department of Orthodontics, 1959 NE Pacific St. Health Sciences Center — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Greg Huang, DMD, MSD, MPH — University of Washington
- Study coordinator: Marilynn Rothen, RDH, MS
- Email: rothen@uw.edu
- Phone: 206-685-8132
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.