Povidone-Iodine for Preventing White Spots

Overseen By Sanghee Lee, DDS, MSc, MS

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Washington

Must not be taking: Antibiotics

Disqualifiers: Iodine allergy, Thyroid disease, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 9 months

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a mouth rinse called Povi-One, containing 10% Povidone-Iodine, can prevent white spots from forming on front teeth during braces treatment. Researchers will determine if this rinse is more effective than a placebo (a treatment with no active ingredient) in preventing these spots. They will also ensure the rinse is safe to use. The trial seeks healthy children and teens, ages 10 to 17, who have braces and at least four adult front teeth. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have a thyroid disease or are using antibiotics regularly, you may not be eligible to participate.

Is there any evidence suggesting that Povi-One is likely to be safe for humans?

Research has shown that Povidone-Iodine is generally safe as a skin antiseptic. Past studies have commonly used it for cleaning skin and treating minor cuts. However, improper use has caused skin irritation or burns in some individuals. When applied as directed, it poses no major safety concerns.

In this trial, participants will use a 10% Povidone-Iodine solution. Following the instructions is crucial to avoid any issues. Participants should report any skin irritation to the study team. The trial aims to assess the safety and effectiveness of this solution in preventing white spots on teeth. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike other treatments for preventing white spots, which often involve fluoride-based solutions or remineralizing agents, the use of 10% Povidone-Iodine offers a novel approach. Povidone-Iodine acts as an antiseptic, potentially reducing bacterial activity that contributes to white spots. Researchers are excited about this treatment because it introduces a new mechanism of action by targeting the root cause of white spots rather than just managing symptoms. Additionally, its topical application is straightforward and could be easily integrated into current oral care routines.

What evidence suggests that Povi-One might be an effective treatment for preventing white spot lesions?

In this trial, participants will receive either a 10% Povidone-Iodine solution or a placebo to evaluate its effectiveness in preventing white spot lesions. Research has shown that 10% Povidone-Iodine can help prevent some dental problems. Specifically, a study on young children found that those who used 10% Povidone-Iodine had healthier teeth after 12 months compared to those who did not. This suggests that Povidone-Iodine might lower the risk of developing early signs of tooth decay, known as white spot lesions, which are common in people with braces. Evidence indicates that Povidone-Iodine could be a helpful way to prevent these spots and maintain healthier teeth. ^{1 3 4 5 6}

Who Is on the Research Team?

Greg Huang, DMD, MSD, MPH

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have at least 4 permanent front teeth in both my upper and lower jaws.

My braces are expected to be on for at least a year.

I am a healthy child or teenager aged between 10 and 17.

Exclusion Criteria

Allergies to iodine

I have been diagnosed with a thyroid condition.

Conditions that could impair routine oral hygiene procedures

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline and Initial Treatment

Povi-One or placebo is applied topically to all tooth surfaces at the consultation appointment before the placement of fixed appliances

1 week

1 visit (in-person)

Treatment

Povi-One or placebo is applied at 3, 6, and 9 months after appliance placement. Participants are monitored for oral lesions and adverse effects.

9 months

3 visits (in-person), 1 visit (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluation of white spot lesions and gingival index

3 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Topical 10% Povidone-Iodine

Trial Overview 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.

How Is the Trial Designed?

Group I: Povidone-iodine solution Experimental Treatment 1 Intervention

10% Povidone and Iodine will be applied

Group II: Placebo Placebo Group 1 Intervention

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

Topical 10% Povidone-Iodine is already approved in United States, European Union for the following indications:

Approved in United States as Povi-One for:

• Prevention of white spot lesions
• Caries prevention

Approved in European Union as Betadine for:

• Prevention of white spot lesions
• Caries prevention
• Oral antiseptic

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Published Research Related to This Trial

In a study involving 150 patients undergoing cataract surgery, a new 5% povidone iodine preparation was found to be safe for the eye, with no harmful effects observed during a 60-day follow-up.

Microbiological tests on 60 patients showed a significant reduction in bacterial colonies in the eye after using the povidone iodine, indicating its effectiveness as an antiseptic before surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Iodized polyvidone (betadine) and prevention of postoperative infection. A multicenter study]. Lagoutte, F., Fosse, T., Jasinski, M., et al.[2017]

Diluted povidone-iodine remains stable for up to 28 days and demonstrates strong antibacterial efficacy against common ocular pathogens like Staphylococcus aureus and Pseudomonas aeruginosa, with effective concentrations as low as 0.078% and 0.3%, respectively.

While povidone-iodine is effective, it can cause mild ocular irritation, especially at higher concentrations, indicating a need for careful concentration management in ophthalmic applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ex vivo evaluation of the stability, safety and antibacterial efficacy of an extemporaneous povidone-iodine preparation for ophthalmic applications. Lee, S., Khun, D., Kumarasinghe, GL., et al.[2020]

Povidone-iodine, while generally considered a low irritant antiseptic, can cause severe contact dermatitis when used improperly, particularly in areas where it pools or is occluded during surgery, as observed in 27 patients evaluated between 2011 and 2013.

The dermatitis typically appeared the day after surgery, and patch testing showed no allergic reaction to povidone-iodine, suggesting that the irritation was due to prolonged skin contact rather than an allergic response, highlighting the need for better drying practices to prevent this complication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Povidone-iodine induced post-surgical irritant contact dermatitis localized outside of the surgical incision area. Report of 27 cases and a literature review. Borrego, L., Hernández, N., Hernández, Z., et al.[2017]

A survey of 28 pediatric surgical units in the UK revealed that most units prefer using Betadine for skin preparation in premature neonates, despite its use being outside the product license.

Evidence suggests that chlorhexidine is more effective than povidone iodine for preoperative skin antisepsis, but both can cause skin damage, and povidone iodine may lead to reactive hypothyroidism in neonates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Antiseptic Use in Pediatric Surgical Units in the United Kingdom-Where Is the Evidence Base? Ng, AL., Jackson, C., Kazmierski, M.[2017]

In a randomized controlled pilot study of adult patients with superficial skin abscesses, the addition of povidone-iodine (PVP-I) to standard incision and drainage (I&D) treatment did not significantly improve clinical cure rates, with 88.2% in the PVP-I group compared to 91.3% in the standard care group.

However, the PVP-I group experienced a significantly higher rate of adverse events (59.6%) compared to the standard care group (26.5%), primarily due to local skin irritation, indicating that while PVP-I may not enhance efficacy, it may increase the risk of side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Study to Evaluate the Adjunct Use of a Povidone-Iodine Topical Antiseptic in Patients with Soft Tissue Abscesses. Olson, AS., Rosenblatt, L., Salerno, N., et al.[2019]

The study found that while 10% Betadine solution effectively inhibited the growth of Staphylococcus aureus, it did not completely kill other tested bacteria, including Staphylococcus epidermidis, Pseudomonas aeruginosa, and Acinetobacter baumannii.

The research highlighted that using only the zone of inhibition assay is insufficient for assessing antimicrobial effectiveness; a colony-forming unit assay is necessary for a more accurate evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An in vitro Study of Betadine's Ability to Eliminate Live Bacteria on the Eye: Should It Be Used for Protection against Endophthalmitis? Nagle, A., Kopel, J., Reed, J., et al.[2022]

In a study involving 105 patients undergoing cataract surgery, 5% povidone-iodine (PI) was found to be significantly more effective than 1% PI in reducing bacterial colonies on the conjunctiva, especially when initial bacterial loads were high.

While in vitro studies suggested that lower concentrations of PI might be more effective, this in vivo study demonstrated that 5% PI resulted in a greater reduction in bacterial counts, indicating its superior efficacy as a preoperative antiseptic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of 5% povidone-iodine solution against 1% povidone-iodine solution in preoperative cataract surgery antisepsis: a prospective randomised double blind study. Ferguson, AW., Scott, JA., McGavigan, J., et al.[2019]

A case study of a one-year-old boy revealed that prolonged exposure to 10% povidone-iodine (PVP-I) for 4 hours led to a chemical burn, highlighting the potential risks of extended use of this antiseptic.

Patch testing indicated that while PVP-I is generally safe, prolonged wet exposure can cause skin irritation or contact dermatitis, as shown by positive reactions in 16 out of 17 volunteers when tested with a wet chamber.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Chemical burn caused by povidone-iodine]. Nakano, S., Uchiyama, A., Ueyama, H., et al.[2017]

The application of 5% povidone iodine (Betadine) to the eye significantly reduced visual acuity and contrast sensitivity in a study of 10 subjects, indicating potential negative effects on visual function.

Betadine also increased subjective complaints of discomfort and corneal staining, suggesting that while it may be effective for disinfection, it can compromise corneal integrity and overall eye comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Povidone Iodine 5% on the Cornea, Vision, and Subjective Comfort. Ridder, WH., Oquindo, C., Dhamdhere, K., et al.[2018]

In a study of 500 emergency department patients with traumatic lacerations, using a topical 1% povidone-iodine solution before suturing significantly reduced the infection rate compared to wounds treated with normal saline alone.

Only 5.4% of wounds treated with povidone-iodine became infected, compared to 15.46% of control wounds, indicating that povidone-iodine is an effective antiseptic for preventing infections in traumatic lacerations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A trial of povidone-iodine in the prevention of infection in sutured lacerations. Gravett, A., Sterner, S., Clinton, JE., et al.[2019]

Povidone-iodine solution (Betadine) is recognized as an effective antiseptic and disinfectant in colorectal surgeries, aimed at reducing postoperative infections and cancer recurrence.

Despite its widespread use, there is a lack of sufficient randomized controlled trials to fully establish the optimal application methods and potential side effects of povidone-iodine in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of povidone-iodine solution in colorectal operations: science or legend. Pattana-arun, J., Wolff, BG.[2017]

A study on Göttingen Minipigs® showed that daily application of 7.5% and 10% povidone-iodine (PVP-I) for up to 39 weeks was safe, with no skin irritation or thyroid dysfunction observed.

Despite increased serum iodine levels, the treatment did not lead to endocrine disruption, suggesting that PVP-I could provide antimicrobial benefits in humans without significant safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of dermal toxicity and toxicokinetics of povidone‑iodine in Göttingen minipigs. Eddy, EP., Shet, MS., Cataldo, M., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06616207?term=AREA%5BConditionSearch%5D(Exanthema)%20AND%20AREA%5BBasicSearch%5D(GOLD)&rank=4

Topical 10% Povidone-Iodine in Preventing White Spots A triple-blind randomized trial with two arms (10% Povidone Iodine, Placebo) where the primary outcome is the percentage of patients with at least one new white ...

2. withpower.com withpower.com/trial/phase-2-white-spot-lesions-8-2024-d1ee8

Povidone-Iodine for Preventing White Spots In a study involving 105 patients undergoing cataract surgery, 5% povidone-iodine (PI) was found to be significantly more effective than 1% PI in reducing ...

3. ctv.veeva.com ctv.veeva.com/study/topical-10-povidone-iodine-in-preventing-white-spots

Topical 10% Povidone-Iodine in Preventing White Spots Design: A triple-blind randomized trial with two arms (10% Povidone Iodine, Placebo) where the primary outcome is the percentage of patients ...

4. researchgate.net researchgate.net/publication/44800659_Efficacy_of_10_Povidone_Iodine_in_Children_Affected_with_Early_Childhood_Caries_An_In_Vivo_Study

Efficacy of 10% Povidone Iodine in Children Affected with ... In a study focusing on the prevention of ECC in 83 children, participants receiving 10% PVP-I exhibited a median 12-month disease-free survival ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7951395/

Povidone–iodine: use in hand disinfection, skin preparation ... Clinically, a 30‐second application was as effective as a 5‐minute PVP‐I preoperative scrub in reducing normal skin flora at inguinal and abdominal sites.

6. elevateoralcare.com elevateoralcare.com/SSP%20Applications/NetSuite%20Inc.%20-%20SCA%202023.1.0/Development/pdf/AD-29.pdf

Povi-One Safety Data Sheet Wear protective gloves, mask, boots, goggles, and other materials for splash prevention. Avoid contact with eyes. Environmental Precautions:.