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Topical 10% Povidone-Iodine in Preventing White Spots

NCT06616207 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-09-27

No results posted yet for this 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

Conditions

  • White Spot Lesions
  • Gingival Inflammation and Bleeding

Interventions

DRUG

Placebo

Placebo (Double distilled water matched in color and taste) will be applied topically by the graduate student to all tooth surfaces at the consultation appointment before the placement of fixed appliances and at 3, 6, and 9 months after appliance placement.

DRUG

Povidone-iodine solution

Povidone-iodine solution will be applied topically by the graduate student to all tooth surfaces at the consultation appointment before the placement of fixed appliances and at 3, 6, and 9 months after appliance placement.

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-13
Primary Completion
2027-03-31
Completion
2027-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06616207 on ClinicalTrials.gov