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Active, not recruiting Phase 2 Interventional Accepts healthy volunteers

Topical 10% Povidone-Iodine in Preventing White Spots

ClinicalTrials.gov ID: NCT06616207

Public ClinicalTrials.gov record NCT06616207. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 11:10 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Efficacy and Safety of Topical 10% Povidone-Iodine in Preventing White Spots During Orthodontic Treatment

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The goal of this clinical trial is to learn if topical application on the all surface of 10% Povidone Iodine (Povi-One) in healthy participants in transitional or permanent dentition (10-17 y) prevents new white spot lesions in the maxillary anterior teeth at 1 year of follow-up. Researchers will compare Povi-One to a placebo to see if Povi-One works to prevent new white spot lesions. It will also learn about the safety of topical 10% Povidone Iodine. The main questions it aims to answer are: 1. Does Povi-One prevent the development of any white spot lesion on the surface of maxillary anterior teeth? 2. Does Povi-One lower the probability of any International Caries Detection and Assessment System (ICDAS) score greater than 0 and mean modified Löe-Silness Gingival Index (GI) in the intervention group? Researchers will 1. Score GI without cleaning participants teeth, then score ICDAS of maxillary and mandibular incisors after participants brush and floss their teeth and take a photograph of maxillary 6 anterior teeth 2. Apply Povi-one (or control) at the consultation appointment before placing fixed orthodontic appliances and 3, 6, and 9 months after appliance placement Researchers will 1. Recall using Zoom 24-48 hours after the first application of Povi-One and examine the participant's mouth for oral lesions using a structured paper checklist 2. Interview the caregiver to complete a paper questionnaire on adverse effects Researchers will 1. Score GI, and then score ICDAS of maxillary and mandibular incisors in 6, 12 months after appliance placement 2. Evaluate the development of white spot lesions on maxillary central and lateral incisors in 6, and 12 months after appliance placement

Study identification

NCT ID
NCT06616207
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 2
Lead sponsor
University of Washington
Other
Enrollment
80 participants

Conditions and interventions

Eligibility (public fields only)

Age range
10 Years to 17 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 12, 2024
Primary completion
Mar 30, 2027
Completion
Mar 30, 2027
Last update posted
Jul 15, 2026

2024 – 2027

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
University of Washington, School of Dentistry Department of Orthodontics, 1959 NE Pacific St. Health Sciences Center Seattle Washington 98195

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06616207, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 15, 2026 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06616207 live on ClinicalTrials.gov.

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