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NCT06616207 · ClinicalTrials.gov registry record · Phase 2
Topical 10% Povidone-Iodine in Preventing White Spots
A Phase 2 study of White Spot Lesions and Gingival Inflammation and Bleeding, sponsored by University of Washington.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT06616207: Recruiting Phase 2 study of White Spot Lesions and Gingival Inflammation and Bleeding, sponsored by University of Washington.
NCT06616207 is a Phase 2 study of White Spot Lesions and Gingival Inflammation and Bleeding that is actively recruiting participants, run by University of Washington. The registered enrollment target is 80 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06616207, a Phase 2 study of White Spot Lesions and Gingival Inflammation and Bleeding, is actively recruiting participants, sponsored by University of Washington.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study Summary
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
Primary Outcome
6 maxillary anterior teeth (central incisors, lateral incisors, and canines) will be photographed with a clinical cam in a 10-degree tilted head position to reduce reflection without drying teeth. A new development of white spot lesion of the maxillary 4 anterior teeth using a photograph at a baseline (before the placement of fixed appliances). The images will be labeled with randomly assigned patient ID numbers and dates, and stored on a password-protected computer for later analysis. The ortho
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Povidone-iodine solution
Study Locations (1)
Washington
- University of Washington, School of Dentistry Department of Orthodontics, 1959 NE Pacific St. Health Sciences Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2024-09-13 |
| Est. Completion | 2027-03-31 |
| Phase | Phase 2 |
What NCT06616207 shows while recruiting
NCT06616207 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower).
The record links to 2 conditions, with White Spot Lesions appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06616207 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT06616207 about?
NCT06616207 is a clinical study titled "Topical 10% Povidone-Iodine in Preventing White Spots". 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 c...
What is the current status of trial NCT06616207?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2024-09-13. Estimated completion is 2027-03-31.
What conditions does trial NCT06616207 study?
This clinical trial studies the following conditions: White Spot Lesions, Gingival Inflammation and Bleeding.
What interventions are being tested in trial NCT06616207?
The interventions under investigation include: Placebo (DRUG), Povidone-iodine solution (DRUG).
Who is sponsoring clinical trial NCT06616207?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06616207 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06616207's enrollment target sits among peer trials
80 842nd of 2000 higher than 1,118 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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