Comparison of bioactive and conventional adhesives on white spot lesion formation during fixed orthodontic treatment – a randomized clinical trial.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- The primary outcome of this study is to compare the two adhesives in minimizing the formation of white spot lesions during fixed orthodontic appliance therapy, evaluated over a 6-months and 12 months period.
研究概览
简要总结
This randomized split-mouth clinical trial aims to compare the effect of a bioactive adhesive and a conventional adhesive on the development of white spot lesions during fixed orthodontic treatment. Orthodontic brackets will be bonded using the bioactive adhesive on one side of the dental arch and the conventional adhesive on the opposite side in each patient. The occurrence of white spot lesions around brackets will be evaluated over time using standardized clinical methods to determine whether the bioactive material offers superior protection against enamel demineralization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 25.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients aged 12–25 years irrespective of gender.
- •2.Fixed orthodontic treatment with extraction or non-extraction treatment plan.
排除标准
- •1.Patients with poor oral hygiene or systemic diseases affecting salivary flow.
- •2.Patients on medications affecting oral microbiota or calcium metabolism.
- •3.Patients not willing to participate in the study.
- •4.No pre-existing enamel lesions or restorations on labial surfaces of teeth.
结局指标
主要结局
The primary outcome of this study is to compare the two adhesives in minimizing the formation of white spot lesions during fixed orthodontic appliance therapy, evaluated over a 6-months and 12 months period.
时间窗: T0- Before treatment | T1- after 6 months | T2- After 12 months
次要结局
- Secondary Outcomes include the severity and distribution of WSLs (mesial, distal, gingival, or occlusal to the bracket). These will be documented to assess lesion pattern distribution using Quantitative Light-induced Fluorescence (QLF).(T0- Before treatment)
研究者
Dr Prerna
AIIMS New Delhi