Comparison of Three Orthodontic Bonding Systems in White Spot Lesion Development: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Average lesion fluorescence loss (ΔF%)
研究概览
简要总结
The gaol of this randomized clinical trial was to compare the effect of self-etching primer bonding system and one step adhesive bonding system on the development of white spot lesions (WSLs) during fixed orthodontic therapy in comparison with the conventional 3 step bonding system.
All participants will be bonded with similar fixed orthodontic appliances using each type of adhesives for the assigned group. WSLs will be monitored during the orthodontic treatment
详细描述
Objectives: The objective of this clinical trial was to compare the effect of self-etching primer bonding system and one step adhesive bonding system on the development of WSLs during fixed orthodontic therapy in comparison with the conventional 3 step bonding system.
Materials and Methods
Seventy five patients were randomly allocated into 3 groups (Group 1, conventional bonding system, n=25; Group 2, self-etch primer n=25; Group 3, primer mixed with the adhesive composite n=25). Quantitative light-induced fluorescence (QLF) was used to quantify WSL parameters. Images were captured and then analyzed before treatment; 2 months and 4 months after bond-up. Lesion area (Pixels), mean fluorescence loss (∆F) and the number of newly developed WSLs were compared within and between the 3 groups. The significance level was set at P ≤ 0.05.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The investigator was capturing the images (that were analyzed to measure the outcomes), while a research assistant was saving the images of the patients with coding system
入排标准
- 年龄范围
- 17 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy patients from both sexes aged 17 - 25 years
- •Mild-to-moderate crowding (≤5 mm)
- •Optimum oral hygiene
- •Maximum of 3 restored teeth
- •Absence of defective enamel formation in the form of hypocalcification or hypoplasia
- •No salivary gland diseases.
排除标准
- •Patients with poor oral hygiene
- •Heavily restored teeth
- •Sever crowding
- •Presence of systemic disease that may affect salivary glands or the ability to brush their teeth properly.
结局指标
主要结局
Average lesion fluorescence loss (ΔF%)
时间窗: 4 months
It reflects mineral loss from tooth surface (in percent)
surface area of WSL
时间窗: 4 months
Area of mineral loss measured in pixels
Incidence of WSL
时间窗: 4 months
Number of newly developed WSLs
次要结局
- Maximum lesion fluorescence loss (ΔFMAX%)(4 months)