Topical 10% Povidone-Iodine in Preventing White Spots

NCT06616207 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: STUDY00019955Protocol #20241690
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does Povi-One prevent the development of any white spot lesion on the surface of maxillary anterior teeth?
2. 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?
3. 3.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
4. 4.Apply Povi-one (or control) at the consultation appointment before placing fixed orthodontic appliances and 3, 6, and 9 months after appliance placement
5. 5.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
6. 6.Interview the caregiver to complete a paper questionnaire on adverse effects
7. 7.Score GI, and then score ICDAS of maxillary and mandibular incisors in 6, 12 months after appliance placement
8. 8.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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Photograph

  6 maxillary anterior teeth (central incisors, lateral incisors, and canines) will be photographed with a clinical cam in a 10-degree tilted head position to reduce reflection without drying teeth. A new development of white spot lesion of the maxillary 4 anterior teeth using a photograph at a baseline (before the placement of fixed appliances). The images will be labeled with randomly assigned patient ID numbers and dates, and stored on a password-protected computer for later analysis. The orthodontic graduate students will be trained to label the photos, and then deliver them to the study coordinator. A trained and calibrated independent evaluator will assess whether there are new white spot lesions by comparing progress with the baseline photos taken before the placement of fixed appliances. The examiner will be blind to group assignments.

  From enrollment (baseline) to the 12 months after the placement of fixed appliances

Secondary Outcomes (2)

• Gingival index

  From enrollment (baseline) to the 12 months after the placement of fixed appliances

• International Caries Detection and Assessment System (ICDAS)

  From enrollment (baseline) to the 12 months after the placement of fixed appliances

Other Outcomes (2)

• Visual analog scale (VAS)

  From enrollment (baseline) to the 12 months after the placement of fixed appliances

• Safety measure (allergic reaction and adverse effect)

  From enrollment (baseline) to the 12 months after the placement of fixed appliances

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo (double distilled water matched in color and taste) will be applied

Drug: Placebo

Povidone-iodine solution

EXPERIMENTAL

10% Povidone and Iodine will be applied

Drug: Povidone-iodine solution

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.

Placebo

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.

Povidone-iodine solution

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy children and teens (10-17 years old)
• Transitional or permanent dentition of at least 4 permanent anterior teeth in each arch
• Full fixed appliance orthodontic treatment is expected to last at least one year

You may not qualify if:

• Allergies to iodine
• Chronic prophylactic use of antibiotics
• Diagnosis of thyroid disease
• Conditions that could impair routine oral hygiene procedures.
• Pregnant at enrollment

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

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

Seattle, Washington, 98195, United States

RECRUITING

Related Publications (6)

• Sundararaj D, Venkatachalapathy S, Tandon A, Pereira A. Critical evaluation of incidence and prevalence of white spot lesions during fixed orthodontic appliance treatment: A meta-analysis. J Int Soc Prev Community Dent. 2015 Nov-Dec;5(6):433-9. doi: 10.4103/2231-0762.167719.

  PMID: 26759794 BACKGROUND

• Julien KC, Buschang PH, Campbell PM. Prevalence of white spot lesion formation during orthodontic treatment. Angle Orthod. 2013 Jul;83(4):641-7. doi: 10.2319/071712-584.1. Epub 2013 Jan 4.

  PMID: 23289733 BACKGROUND

• Buschang PH, Chastain D, Keylor CL, Crosby D, Julien KC. Incidence of white spot lesions among patients treated with clear aligners and traditional braces. Angle Orthod. 2019 May;89(3):359-364. doi: 10.2319/073118-553.1. Epub 2018 Dec 17.

  PMID: 30556747 BACKGROUND

• Sharab L, Loss C, Jensen D, Kluemper GT, Alotaibi M, Nagaoka H. Prevalence of white spot lesions and gingival index during orthodontic treatment in an academic setting. Am J Orthod Dentofacial Orthop. 2023 Jun;163(6):835-842. doi: 10.1016/j.ajodo.2022.08.023. Epub 2023 Jan 29.

  PMID: 36720655 BACKGROUND

• Richter AE, Arruda AO, Peters MC, Sohn W. Incidence of caries lesions among patients treated with comprehensive orthodontics. Am J Orthod Dentofacial Orthop. 2011 May;139(5):657-64. doi: 10.1016/j.ajodo.2009.06.037.

  PMID: 21536209 BACKGROUND

• Lucchese A, Gherlone E. Prevalence of white-spot lesions before and during orthodontic treatment with fixed appliances. Eur J Orthod. 2013 Oct;35(5):664-8. doi: 10.1093/ejo/cjs070. Epub 2012 Oct 8.

  PMID: 23045306 BACKGROUND

MeSH Terms

Conditions

Gingivitis; Hemorrhage

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Greg Huang, DMD, MSD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marilynn Rothen, RDH, MS

CONTACT

206-685-8132; rothen@uw.edu

Sanghee Lee, DDS, MSc, MS

CONTACT

206-616-4081; slee1119@uw.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The manufacturer of Povi-One will provide the placebo. The products will be identical in appearance. Povi-One and placebo will be supplied every 6 months and stored at room temperature in locked storage in the orthodontics clinic. Povi-One and placebo will be delivered to the clinic site by the manufacturer marked with the different treatment codes. The study biostatistician will assign the codes and keep the key. The manufacturer will retain treatment codes until after analysis.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor: Orthodontics

Model Details: In triple blind parallel interventional study model, two or more groups of participants are treated simultaneously but separately, with an intervention group (10% povidone-iodine) and placebo (double distilled water colored to match the Povidone-Iodine solution in color and taste)and will be randomly assigned at the recruitment. The researchers compare the results between the groups to see if the intervention has a preventive effect. All three parties, participants, researcher, and data analyst are unaware of who is receiving which treatment between intervention and placebo to produce the most unbiased and reliable results.

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 27, 2024
• Study Start: September 13, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: September 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)