Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06616207
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
Topical 10 Povidone-Iodine in Preventing White Spots
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy and Safety of Topical 10 Povidone-Iodine in Preventing White Spots During Orthodontic Treatment
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 participants 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
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 participants 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
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
RecruitmentConsent
The participants will be recruited as they begin treatment The orthodontic graduate student will briefly present the study and ask if the childteen and caregiver parent guardian are willing to talk about the study and then if the childteen and caregiver are willing a research assistant will further explain participation and gain informed assent from the childteen 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 andor 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 005 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 430 R Core Team 2023
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
RecruitmentConsent
The participants will be recruited as they begin treatment The orthodontic graduate student will briefly present the study and ask if the childteen and caregiver parent guardian are willing to talk about the study and then if the childteen and caregiver are willing a research assistant will further explain participation and gain informed assent from the childteen 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 andor 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 005 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 430 R Core Team 2023
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None