Treatment of White Spot Lesions After Orthodontic Treatment: A Practice-based Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Improvement as rated by blinded assessors viewing photographs before and after treatment.
研究概览
简要总结
The purpose of this study is to learn more about the management of white spot lesions that occur after orthodontic treatment. White spot lesions generally improve slightly with time. To date, there is no proven method to help white spot lesions improve faster. Two treatments, called MI Paste Plus and fluoride varnish, have shown some potential benefits in a laboratory setting but have not undergone testing in a clinical setting. Approximately 240 subjects are to be enrolled in this study. The study will take place in approximately 30 dental and orthodontic offices across Idaho, Montana, Oregon, Utah, and Washington as part of Northwest PRECEDENT, a five-state research network that was created to study the practical issues facing dentists/orthodontists and their patients, and to provide information that will improve the quality of oral health care as a whole. Researchers at the University of Washington and Oregon Health & Science University share management and oversight of the network and research projects.
详细描述
White spot lesions (WSL), caused by the decalcification of enamel, are a common and unfortunate sequela of orthodontic treatment. If not addressed, WSL may progress to caries and frank cavitation of the enamel surface. Once formed, white spot lesions compromise esthetics and can be extremely difficult or even impossible to reverse. Many clinicians consider a high-dose fluoride application to be the first step in treatment of WSL in order to arrest areas of decalcification. However, some believe that while remineralization with high levels of fluoride may repair the surface of enamel, it may possibly block remineralization of the deeper areas of enamel. This, in turn, may hamper efforts to normalize the appearance of WSL.
Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) containing products are a recently proposed therapy for the treatment of white spots following orthodontic treatment. CPP is thought to stabilize and localize calcium, fluoride, and phosphate at the tooth surface in a slow-release amorphous form, thus enhancing deeper remineralization of WSL. Products containing CPP-ACP are currently marketed under various names, including MI Paste Plus (which also contains fluoride). Few in vivo studies have investigated the effectiveness of various remineralization products to address WSL after orthodontics. This project is a single-blind, randomized clinical trial with three arms - MI Paste Plus for an 8-week duration, a single application of Duraphat Fluoride Varnish with reassessment at 8 weeks, and normal home care for an 8 week period. Subjects will be recruited at their regularly scheduled orthodontic appointments, with eligible subjects being up to 2 years post-removal of fixed orthodontic appliances.
This project is intended to answer four questions regarding the management of white spot lesions.
Specific Aim 1: to compare the effectiveness MI Paste Plus and Duraphat Fluoride Varnish to a standard oral hygiene/toothpaste regimen in improving the appearance of WSL after orthodontic treatment.
Specific Aim 2: to investigate subjects' self-assessment of improvement in each of the three arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Completed fixed appliance orthodontic therapy within the past two years
- •Have at least one white spot lesion on the facial surface of a maxillary central or lateral incisor tooth that was not present prior to treatment with fixed orthodontic appliances.
- •Between the ages of 12 and 20 years of age
- •Agrees to randomization to the different treatment protocols
- •Signed informed consent obtained from a parent or guardian of the patient f the patient is under the age of eighteen
排除标准
- •Not willing to be randomly assigned to one of the three treatment groups
- •Any abnormal oral, medical, or mental conditions, including any milk-related allergies and/or any medical conditions involving the kidneys.
- •Any patients who underwent therapy for white spot lesion after completion of orthodontic treatment
- •Any white spot lesion present on qualifying teeth with frank cavitation
- •Patient is non-English speaking or non-English reading
结局指标
主要结局
Improvement as rated by blinded assessors viewing photographs before and after treatment.
时间窗: 8 weeks
次要结局
- To investigate subjects' self-assessment of improvement against a group of blinded examiners for the amelioration of WSL.(8 weeks)
- Improvement as rated by blinded assessors viewing photographs in the period between the day of orthodontic appliance removal and retainer delivery.(2-7 days)
- To investigate variables (age, gender, time since fixed orthodontic appliance removal, compliance, oral hygiene practices, etc) that may influence WSL regression and the effectiveness of the treatment and control groups.(8 weeks)
研究者
Greg Huang
Principal Investigator
University of Washington