Incidence of White Spot Lesions Around Ceramic Brackets Compared With Metal Brackets Evaluated With Quantitative Light-induced Fluorescence: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Lesion area
研究概览
简要总结
The main objective of this study was to investigate the relation between ceramic brackets and the development of white spot lesions (WSLs) compared to that associated with conventional metal brackets.
详细描述
Objectives : The main objective of this study was to investigate the relation between ceramic brackets and the development of WSL compared to that associated with conventional metal brackets.
Study design: Randomized 2-parallel arm clinical trial. Materials and methods: Quantitative light induced fluorescence (QLF) images were taken for the two randomly allocated groups (Ceramic group, n=26; Metal group, n=25) of patients at T0: before the start of treatment; T1: after 2 months and T2: at 4 months after treatment). The QLF images were analyzed; Primary outcome measures: The lesion area (Pixels) and Mean amount of fluorescence loss (∆F)% and the number of newly developed lesions. Secondary outcome: Maximum fluorescence loss (∆F-Max)% and plaque surface area (∆R 30)%. Means and standard deviations for all the measured parameters at T0, T1 and T2 were calculated. Split plot analysis of variance (SPANOVA) test was used to determine the changes within each group at the different time intervals, and between the two groups. Chi square was used to compare between the two groups regarding the number of new lesions during the treatment. P value was set at 0.05 level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
It was not possible to mask nether the participants nor the care provider
入排标准
- 年龄范围
- 18 Years 至 35 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects seeking orthodontic treatment with mild-to-moderate crowding (not exceeding 5 mm)
- •No previous orthodontic treatment
- •Optimum oral hygiene
- •Maximum of 3 restored teeth
- •Absence of defective enamel formation in the form of hypocalcification or hypoplasia.
排除标准
- •Subjects with poor oral hygiene
- •Defective enamel
- •Patients with syndromes and Oro-facial anomalies or salivary glands diseases
结局指标
主要结局
Lesion area
时间窗: 4 months
Surface area of the lesion measured in Pixels
Incidence of white spot lesions
时间窗: 4 months
The number of newly developed white spot lesions
Maximum fluorescence loss ∆Fmax(%)
时间窗: 4 months
Deepest point of the lesion
Mean fluorescence loss ∆F(%)
时间窗: 4 months
Mean lesion fluorescence loss reflecting mineral loss measured in percent
次要结局
- Plaque measurement(4 months)
