← Back to Search

Antiseptic

Povidone-Iodine for Preventing White Spots

Phase 2
Recruiting
Led By Greg Huang, DMD, MSD, MPH
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Transitional or permanent dentition of at least 4 permanent anterior teeth in each arch
Healthy children and teens (10-17 years old)
Must not have
Chronic prophylactic use of antibiotics
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment (baseline) to the 12 months after the placement of fixed appliances

Summary

This trial aims to see if using a 10% Povidone Iodine solution can prevent new white spot lesions on the front teeth of teenagers. They will compare the Povidone Iod

Who is the study for?
This trial is for healthy individuals aged 10-17 with transitional or permanent teeth, who are getting fixed orthodontic appliances. They should not have any existing white spot lesions on their maxillary anterior teeth.
What is being tested?
The study tests if a topical solution called Povi-One (10% Povidone-Iodine) can prevent new white spot lesions on the front upper teeth over one year compared to a placebo. It involves applying the solution at specific times and monitoring through dental exams.
What are the potential side effects?
Potential side effects may include oral irritation or lesions, which will be checked via Zoom shortly after application. Caregivers will also report any adverse effects observed in participants.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have at least 4 permanent front teeth in both my upper and lower jaws.
Select...
I am a healthy child or teenager aged between 10 and 17.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I regularly take antibiotics to prevent infections.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment (baseline) to the 12 months after the placement of fixed appliances
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment (baseline) to the 12 months after the placement of fixed appliances for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Photograph
Secondary study objectives
Gingival index
International Caries Detection and Assessment System (ICDAS)
Other study objectives
Safety measure (allergic reaction and adverse effect)
Visual analog scale (VAS)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Povidone-iodine solutionExperimental Treatment1 Intervention
10% Povidone and Iodine will be applied
Group II: PlaceboPlacebo Group1 Intervention
Placebo (double distilled water matched in color and taste) will be applied
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Povidone-iodine solution
2015
Completed Phase 2
~100

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,809 Previous Clinical Trials
1,913,341 Total Patients Enrolled
Greg Huang, DMD, MSD, MPHPrincipal InvestigatorUniversity of Washington
~53 spots leftby Mar 2027