Efficacy and Safety of Topical 10% Povidone-Iodine in Preventing White Spots During Orthodontic Treatment
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Photograph
研究概览
简要总结
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
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Allergies to iodine
- •Chronic prophylactic use of antibiotics
- •Diagnosis of thyroid disease
- •Conditions that could impair routine oral hygiene procedures.
- •Pregnant at enrollment
研究组 & 干预措施
Povidone-iodine solution
10% Povidone and Iodine will be applied
干预措施: Povidone-iodine solution (Drug)
Placebo
Placebo (double distilled water matched in color and taste) will be applied
干预措施: Placebo (Drug)
结局指标
主要结局
Photograph
时间窗: 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.
次要结局
- 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)
研究者
Greg Huang
Professor: Orthodontics
University of Washington