Actively Recruiting
Topical 10% Povidone-Iodine in Preventing White Spots
Led by University of Washington · Updated on 2024-09-27
80
Participants Needed
1
Research Sites
132 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Topical 10% Povidone-Iodine in Preventing White Spots
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy children and teens aged 10 to 17 years
- Transitional or permanent dentition with at least 4 permanent anterior teeth in each arch
- Expected fixed orthodontic treatment lasting at least one year
You will not qualify if you...
- Allergy to iodine
- Chronic prophylactic use of antibiotics
- Diagnosis of thyroid disease
- Conditions impairing routine oral hygiene
- Pregnancy at enrollment
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Washington, School of Dentistry Department of Orthodontics, 1959 NE Pacific St. Health Sciences Center
Seattle, Washington, United States, 98195
Actively Recruiting
Research Team
M
Marilynn Rothen, RDH, MS
CONTACT
S
Sanghee Lee, DDS, MSc, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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