White Spot LesionsPhase 2NCT06616207
Topical 10% Povidone-Iodine in Preventing White Spots
A Phase 2 study testing Povidone-iodine solution in people with White Spot Lesions and Gingival Inflammation and Bleeding, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesions, Gingival Inflammation and Bleeding
- What is being tested?
- Povidone-iodine solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2024to 31 Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Allergies to iodine
- Chronic prophylactic use of antibiotics
- Diagnosis of thyroid disease
- Conditions that could impair routine oral hygiene procedures.
- Pregnant at enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington, School of Dentistry Department of Orthodontics, 1959 NE Pacific St. Health Sciences Center
Seattle, Washington, 98195
About this study
Official title: Efficacy and Safety of Topical 10% Povidone-Iodine in Preventing White Spots During Orthodontic Treatment
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.
Read more
It will also learn about the safety of topical 10% Povidone Iodine.
The main questions it aims to answer are:
- Does Povi-One prevent the development of any white spot lesion on the surface of maxillary anterior teeth?
- 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
- 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
- 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
- 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
- Interview the caregiver to complete a paper questionnaire on adverse effects
Researchers will
- Score GI, and then score ICDAS of maxillary and mandibular incisors in 6, 12 months after appliance placement
- Evaluate the development of white spot lesions on maxillary central and lateral incisors in 6, and 12 months after appliance placement
Read the detailed description
Protocol:
Efficacy and Safety Of Topical 10% Povidone-Iodine In Preventing White Spots During Orthodontic Treatment
Design:
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 spot lesion on the maxillary anterior teeth at 1 year of follow-up. The secondary outcomes will utilize the ICDAS on the upper and lower anterior teeth, a modified Gingival Index, and Acceptability.
Hypothesis:
Participants treated with the test agent will be less likely to develop any enamel decalcification than participants treated with the placebo comparator. Also, the probability of any ICDAS score greater than 0 and mean modified Gingival Index will be lower in the treatment group than in the comparator.
Recruitment/Consent:
The participants will be recruited as they begin treatment. The orthodontic graduate student will briefly present the study and ask if the child/teen and caregiver (parent, guardian) are willing to talk about the study and then, if the child/teen and caregiver are willing, a research assistant will further explain participation and gain informed assent from the child/teen and consent from the parent.
Intervention:
Povi-One (10% povidone-iodine) will be applied topically by the graduate student to all tooth surfaces at the consultation appointment (baseline) before the placement of fixed appliances. Povi-one (or control) will be applied again at 3, 6, and 9 months after appliance placement by the graduate student.
Control:
The placebo (double distilled water colored to match the Povidone-Iodine solution in color and taste) application procedure is identical to that of the test product. The manufacturer will provide the placebo.
Concomitant Treatment:
No change will be made in orthodontic treatment. Any application of fluorides or other dental treatment will be recorded from the EHR. The participant and/or caregiver will be asked whether the participant is using any OTC fluoride products or had any fluoride applied by their dentist.
Management of agents (Povi-One and placebo) Povi-One and placebo will be delivered to the clinic site by the manufacturer marked with the different treatment codes. Treatment codes will be retained by the manufacturer until after analysis. Fresh products will be supplied every 6 months and stored at room temperature in locked storage in the orthodontics clinic.
Retention:
The drop-out rate of patients in the graduate orthodontic clinic once treatment begins is less than 5%
Sample size determination:
The sample size is based on recent data collected on adolescent patients in the UW graduate orthodontic clinic. Assuming a 50% incidence of any new white spot lesions, as identified by intra-oral photographs at 12 months in the placebo sample, and a reduction of 60% in the test sample, the sample size based on a two-sample chi-square test using a 0.05 significance level and 80% power is 39 participants per group (78 total) without accounting for attrition. Assuming 5% attrition at 12 months, the sample size required is 41 per group (82 total). Assuming an 80% acceptance rate and about 125 new patients in the required age range per year at the UW graduate orthodontic clinic, the sample of 80 patients can be accrued in one 1 year.
Data Management:
The demographic data, clinical evaluation data, and post-treatment reports will be recorded on paper forms precoded with the participant ID. These forms will be collected and kept in a locked file until entered into a computer database. The photographic images will be identified by participant ID and date and uploaded to a secure study computer.
Analysis:
The analysis will be based on the intention-to-treat principle. Binary outcomes will be summarized for each study arm and time point by frequency and percentage and quantitative outcomes will be summarized by mean, standard deviation, median, interquartile range, and range. A chi-square test will be used to compare the percentage of patients in each group that develop at least one new white spot lesion. A chi-square will be also used to compare the incidence of any ICDAS score greater than 0 and a two-sample test will be used to compare the mean modified Gingival Index and Acceptability. If the distribution of the modified Gingival Index or Acceptability is skewed, a non-parametric Mann-Whitney U test will be used. Log-linear regression with robust standard errors will used to compare the number of new ICDAS scores greater than 0 if sufficient numbers of participants have more than 1 new lesion (Hardin et al., 2003). If the attrition is greater than 10% at 12 months, multiple imputation methods will be used to account for the missing data and maintain the intention-to-treat analysis (Rubin et al., 1987). All analysis will be performed using R Version 4.3.0 (R Core Team, 2023).
- Being tested
- Placebo, Povidone-iodine solution
- 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
- Medical subject headings
- Gingivitis, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
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 solutionDrug
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 group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo (double distilled water matched in color and taste) will be applied Receives: Drug: Placebo |
| Povidone-iodine solution | Experimental | 10% Povidone and Iodine will be applied Receives: Drug: Povidone-iodine solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment (baseline) to the 12 months after the placement of fixed appliances
Secondary outcomes (2)
Gingival index
The gingival index will be evaluated at the baseline (before the placement of the fixed appliances, 6 months, and 12 months after the placement) Scoring gingival index will be performed before the patient performs any oral hygiene procedures at the time of the visit. A modification of the Löe-Silness Gingival Index (GI) will be used, scoring the mid-labial aspect of the gingiva of each anterior tooth on a scale from 0 (normal gingiva); 1 (Mild inflammation: slight change in color and slight edema but no bleeding on probing); 2 (Moderate inflammation: redness, edema, and glazing, bleeding on probing); to 3 (severe inflammation: marked redness and edema, ulceration with tendency to spontaneous bleeding). Orthodontic graduate students will receive training and complete a calibration exercise for scoring the GI.
Measured: From enrollment (baseline) to the 12 months after the placement of fixed appliances
International Caries Detection and Assessment System (ICDAS)
After the gingival index has been completed, patients will be asked to brush and floss their teeth, and any residual plaque can be removed with a micro brush.
ICDAS will be evaluated at the baseline (before the placement of the fixed appliances, 6 months, and 12 months after the placement). Regarding the ICDAS, only the anterior teeth will be assessed clinically by the graduate orthodontic student. No magnification will be used. The graduate student examiners will be trained and calibrated to establish inter-rater reliability on a sample of 10 patients with and without ICDAS pre-cavitated lesions by a trained gold standard examiner . (Minimum acceptable ICC=.7) A review for examiners will be held for 1 year.
Measured: From enrollment (baseline) to the 12 months after the placement of fixed appliances
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start13 Sep 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for White Spot LesionsStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Greg Huang, University of Washington
- Investigators
- Greg Huang, DMD, MSD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06616207
- Sponsor's protocol ID
- STUDY00019955
- Other IDs
- STUDY00019955, Protocol #20241690
- Status last verified
- Apr 2026
- First submitted
- 20 Sep 2024
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing IPD will be restricted or carefully managed to ensure participants safety. Researchers have ethical obligations to protect the participants. When individuals agree to participate in a trial, they often do so with the understanding that their personal data will remain confidential. Also, Participants may not have given explicit consent for their data to be shared beyond the scope of the specific clinical trial. Especially in this trial, participants are children and teenagers under 18 considered a vulnerable population in clinical trials, so additional precautions are taken to ensure their safety and privacy. Protecting the individual participant data of minor participants in clinical trials is crucial due to their vulnerable status, the legal requirements, and the potential for harm that could arise from breaches in privacy or confidentiality.
Publications
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.
PubMed 26759794Julien 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.
PubMed 23289733Buschang 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.
PubMed 30556747Sharab 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.
PubMed 36720655Richter 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.
PubMed 21536209Lucchese 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.
PubMed 23045306
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Topical 10% Povidone-Iodine in Preventing White Spots During Orthodontic Treatment
- ClinicalTrials.gov ID
- NCT06616207
- Acronym / sponsor ID
- STUDY00019955
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 13 Sep 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 27 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does Povi-One prevent the development of any white spot lesion on the surface of maxillary anterior teeth?
- 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
- 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
- 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
- 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
- Interview the caregiver to complete a paper questionnaire on adverse effects
Researchers will
- Score GI, and then score ICDAS of maxillary and mandibular incisors in 6, 12 months after appliance placement
- Evaluate the development of white spot lesions on maxillary central and lateral incisors in 6, and 12 months after appliance placement
Detailed description
Protocol:
Efficacy and Safety Of Topical 10% Povidone-Iodine In Preventing White Spots During Orthodontic Treatment
Design:
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 spot lesion on the maxillary anterior teeth at 1 year of follow-up. The secondary outcomes will utilize the ICDAS on the upper and lower anterior teeth, a modified Gingival Index, and Acceptability.
Hypothesis:
Participants treated with the test agent will be less likely to develop any enamel decalcification than participants treated with the placebo comparator. Also, the probability of any ICDAS score greater than 0 and mean modified Gingival Index will be lower in the treatment group than in the comparator.
Recruitment/Consent:
The participants will be recruited as they begin treatment. The orthodontic graduate student will briefly present the study and ask if the child/teen and caregiver (parent, guardian) are willing to talk about the study and then, if the child/teen and caregiver are willing, a research assistant will further explain participation and gain informed assent from the child/teen and consent from the parent.
Intervention:
Povi-One (10% povidone-iodine) will be applied topically by the graduate student to all tooth surfaces at the consultation appointment (baseline) before the placement of fixed appliances. Povi-one (or control) will be applied again at 3, 6, and 9 months after appliance placement by the graduate student.
Control:
The placebo (double distilled water colored to match the Povidone-Iodine solution in color and taste) application procedure is identical to that of the test product. The manufacturer will provide the placebo.
Concomitant Treatment:
No change will be made in orthodontic treatment. Any application of fluorides or other dental treatment will be recorded from the EHR. The participant and/or caregiver will be asked whether the participant is using any OTC fluoride products or had any fluoride applied by their dentist.
Management of agents (Povi-One and placebo) Povi-One and placebo will be delivered to the clinic site by the manufacturer marked with the different treatment codes. Treatment codes will be retained by the manufacturer until after analysis. Fresh products will be supplied every 6 months and stored at room temperature in locked storage in the orthodontics clinic.
Retention:
The drop-out rate of patients in the graduate orthodontic clinic once treatment begins is less than 5%
Sample size determination:
The sample size is based on recent data collected on adolescent patients in the UW graduate orthodontic clinic. Assuming a 50% incidence of any new white spot lesions, as identified by intra-oral photographs at 12 months in the placebo sample, and a reduction of 60% in the test sample, the sample size based on a two-sample chi-square test using a 0.05 significance level and 80% power is 39 participants per group (78 total) without accounting for attrition. Assuming 5% attrition at 12 months, the sample size required is 41 per group (82 total). Assuming an 80% acceptance rate and about 125 new patients in the required age range per year at the UW graduate orthodontic clinic, the sample of 80 patients can be accrued in one 1 year.
Data Management:
The demographic data, clinical evaluation data, and post-treatment reports will be recorded on paper forms precoded with the participant ID. These forms will be collected and kept in a locked file until entered into a computer database. The photographic images will be identified by participant ID and date and uploaded to a secure study computer.
Analysis:
The analysis will be based on the intention-to-treat principle. Binary outcomes will be summarized for each study arm and time point by frequency and percentage and quantitative outcomes will be summarized by mean, standard deviation, median, interquartile range, and range. A chi-square test will be used to compare the percentage of patients in each group that develop at least one new white spot lesion. A chi-square will be also used to compare the incidence of any ICDAS score greater than 0 and a two-sample test will be used to compare the mean modified Gingival Index and Acceptability. If the distribution of the modified Gingival Index or Acceptability is skewed, a non-parametric Mann-Whitney U test will be used. Log-linear regression with robust standard errors will used to compare the number of new ICDAS scores greater than 0 if sufficient numbers of participants have more than 1 new lesion (Hardin et al., 2003). If the attrition is greater than 10% at 12 months, multiple imputation methods will be used to account for the missing data and maintain the intention-to-treat analysis (Rubin et al., 1987). All analysis will be performed using R Version 4.3.0 (R Core Team, 2023).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (double distilled water matched in color and taste) will be applied |
| Povidone-iodine solution | Experimental | Drug: Povidone-iodine solution10% Povidone and Iodine will be applied |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- Allergies to iodine
- Chronic prophylactic use of antibiotics
- Diagnosis of thyroid disease
- Conditions that could impair routine oral hygiene procedures.
- Pregnant at enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo (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 | Placebo |
| Povidone-iodine solutionPovidone-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. | Drug | Povidone-iodine solution |
Primary outcome
Photograph
Time frame: From enrollment (baseline) to the 12 months after the placement of fixed appliances
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.
2 secondary outcomes
Gingival index
Time frame: From enrollment (baseline) to the 12 months after the placement of fixed appliances
International Caries Detection and Assessment System (ICDAS)
Time frame: From enrollment (baseline) to the 12 months after the placement of fixed appliances
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Background: PubMed 26759794Sundararaj 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.
- Background: PubMed 23289733Julien 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.
- Background: PubMed 30556747Buschang 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.
- Background: PubMed 36720655Sharab 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.
- Background: PubMed 21536209Richter 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.
- Background: PubMed 23045306Lucchese 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.
- Individual participant dataSharing planned: No. Sharing IPD will be restricted or carefully managed to ensure participants safety. Researchers have ethical obligations to protect the participants. When individuals agree to participate in a trial, they often do so with the understanding that their personal data will remain confidential. Also, Participants may not have given explicit consent for their data to be shared beyond the scope of the specific clinical trial. Especially in this trial, participants are children and teenagers under 18 considered a vulnerable population in clinical trials, so additional precautions are taken to ensure their safety and privacy. Protecting the individual participant data of minor participants in clinical trials is crucial due to their vulnerable status, the legal requirements, and the potential for harm that could arise from breaches in privacy or confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Greg Huang, DMD, MSD, MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Povidone-iodine solution in people with White Spot Lesions and Gingival Inflammation and Bleeding, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Photograph (time frame: From enrollment (baseline) to the 12 months after the placement of fixed appliances). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06616207, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.