Topical 10% Povidone-Iodine in Preventing White Spots

Conditions

• Gingival Inflammation and Bleeding
• White Spot Lesions

Eligibility Criteria

Sex

ALL

Age

10 Years - 17 Years

Healthy Volunteers

Accepted

Interventions

• Placebo — DRUG
  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.
• Povidone-iodine solution — DRUG
  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.

Study Details

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

Key Dates

Start date

Sep 13, 2024

Status verified

Aug 2024

Primary completion

Mar 31, 2027

Completion

Mar 31, 2027

Study Design

Enrollment

80 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Placebo Comparator: Placebo
  Placebo (double distilled water matched in color and taste) will be applied
• Experimental: Povidone-iodine solution
  10% Povidone and Iodine will be applied

Primary Outcome Measure

Photograph [ Time Frame: From enrollment (baseline) to the 12 months after the placement of fixed appliances ]

Central Contacts

• Marilynn Rothen, RDH, MS
  206-685-8132
  [email protected]
• Sanghee Lee, DDS, MSc, MS
  206-616-4081
  [email protected]

Locations (1)

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