Actively Recruiting

Phase 2
Age: 10Years - 17Years
All Genders
Healthy Volunteers
NCT06616207

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

Age: 10Years - 17Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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