RECRUITING

Topical 10% Povidone-Iodine in Preventing White Spots

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-09-13
Study Completion:2027-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06616207

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:10 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Healthy children and teens (10-17 years old)
  2. * Transitional or permanent dentition of at least 4 permanent anterior teeth in each arch
  3. * Full fixed appliance orthodontic treatment is expected to last at least one year
  1. * Allergies to iodine
  2. * Chronic prophylactic use of antibiotics
  3. * Diagnosis of thyroid disease
  4. * Conditions that could impair routine oral hygiene procedures.
  5. * Pregnant at enrollment

Contacts and Locations

Study Contact

Marilynn Rothen, RDH, MS
CONTACT
206-685-8132
rothen@uw.edu
Sanghee Lee, DDS, MSc, MS
CONTACT
206-616-4081
slee1119@uw.edu

Principal Investigator

Greg Huang, DMD, MSD, MPH
PRINCIPAL_INVESTIGATOR
University of Washington

Study Locations (Sites)

University of Washington, School of Dentistry Department of Orthodontics, 1959 NE Pacific St. Health Sciences Center
Seattle, Washington, 98195
United States

Collaborators and Investigators

Sponsor: University of Washington

  • Greg Huang, DMD, MSD, MPH, PRINCIPAL_INVESTIGATOR, University of Washington

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-13
Study Completion Date2027-03-31

Study Record Updates

Study Start Date2024-09-13
Study Completion Date2027-03-31

Terms related to this study

Keywords Provided by Researchers

  • Povidone-Iodine
  • White spot lesion
  • Topical application of 10% Povidone- Iodine in preventing white spots
  • Topical 10% Povidone-Iodine In Preventing White Spots During Orthodontic Treatment

Additional Relevant MeSH Terms

  • White Spot Lesions
  • Gingival Inflammation and Bleeding