Comparative study on levels of RANKL and OPG in gingival crevicular fluid associated with tooth movement induced by aligners and conventional fixed orthodontic treatment: A prospective study.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Difference in the levels of biomarkers will be assessed.
研究概览
简要总结
This prospective study aims to assess changes in bone metabolism biomarkers RANKL and OPG in gingival crevicular fluid (GCF) of patients undergoing treatment with clear aligners and fixed orthodontic treatment. Clear aligners, which are a newer orthodontic treatment modality, have not been explored extensively for changes in biologic mediators with the application of orthodontic forces. A long-term assessment of changes in biomarkers in biological fluids can provide evidence of changes at the biological level and its efficacy when compared to conventional fixed orthodontic treatment. The study will comprise of 20 patients of age group 15- 30 years willing to undergo orthodontic treatment with clear aligners and fixed orthodontic treatment. The gingival crevicular fluid samples of 10 patients with bimaxillary protrusion from each group, who have been subjected to extraction of all premolars, will be collected before beginning the treatment, 24 hours after intervention, 21 days after intervention, and after 6 months of intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 15.00 Year(s) 至 30.00 Year(s)(—)
- 性别
- All
入选标准
- •Bimaxillary protrusion cases that require extraction of all 1st premolars for orthodontic correction.
- •No history of antibiotics and anti-inflammatory drugs in past 6 months preceding the study.
- •Periodontally healthy, with generalised probing depth less than or equal to 3 mm.
排除标准
- •Presence of gingivitis and periodontitis Presence of Systemic disease Presence of bone disease History of previous orthodontic treatment Smoking habit.
结局指标
主要结局
Difference in the levels of biomarkers will be assessed.
时间窗: T0- GCF collected at beginning of treatment | T1 - GCF collected 24 hours after intervention. | T2- GCF collected after 21 days of intervention | T4 – GCF collected after 6 months of intervention
次要结局
- Assessment of RANKL/OPG ratio.(T0- GCF collected at beginning of treatment)
研究者
Dr Taanvi Miglani
Manav Rachna Dental College
