THE EFFICACY OF MI VARNISH VERSUS PRO SEAL SEALANT ON PREVENTION OF WHITE SPOT LESIONS IN ORTHODONTIC PATIENTS: A RANDOMIZED CLINICAL TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Enamel Decalcification Index
研究概览
简要总结
The purpose of the study is o compare the efficacy of CPP-ACP MI Varnish and ProSeal sealant in preventing white spot lesion (WSL) formation in orthodontic patients.
详细描述
This prospective randomized clinical trial included 40 orthodontic patients between the ages of 12-17 who were randomly allocated to two groups. Group 1 (Sealant Group) received sealant on the maxillary anterior canines, lateral incisors, and central incisors, with reapplication of the sealant every 3 months. Group 2 (Varnish Group) had MI Varnish applied every 4-6 weeks, without sealant placed on the maxillary anterior teeth. White spot lesion formation was evaluated with standardized digital photographs at two timepoints, T1 (initial appointment before bonding), and T2 (12 months later, with brackets removed). The brackets were removed in order to facilitate an adequate photographic exam. Photographs were analyzed side-by-side at the conclusion of the study with the Enamel Decalcification Index (EDI). The location of WSLs were recorded by tooth type and by region. Oral hygiene was evaluated at T1 and T2.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •no significant medical history
- •no underlying medical problems such as Sjogren's Syndrome or conditions requiring more than 2 medications (to prevent bias of possible dry mouth)
- •less than 17 years old at the start of orthodontic treatment,
- •fully erupted permanent maxillary canines and incisors, starting fixed orthodontic treatment
- •ability to come to appointments every 4-6 weeks.
排除标准
- •professional fluoride application in the last 3 months
- •allergy to milk
- •untreated cavitated lesions
- •heavy initial fluorosis
- •dry mouth
- •pregnancy
- •any illness/condition that the investigators felt would affect the study outcome.
结局指标
主要结局
Enamel Decalcification Index
时间窗: 12 months
Extent and severity of white spot lesion formation
次要结局
- Location of White Spot Lesions(12 months)
- Most Common Tooth for White Spot Formation(12 Months)
- Oral Hygiene Status(12 Months)
- Sex Differences(12 Months)