Changes in the levels of apolipoprotein E in saliva during clear aligner therapy and fixed orthodontic treatment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Changes in the level of Apolipoprotein E
研究概览
简要总结
This prospective study aims to assess changes in biomarker Apolipoprotein E in salivary samples 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 32 patients of age group 15- 30 years willing to undergo orthodontic treatment with clear aligners and fixed orthodontic treatment. The salivary samples of 16 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
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 15.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- All
入选标准
- •a)Age group from 15-30 years b) Bimaxillary protrusion cases that require extraction of all premolars for orthodontic correction.
- •c) No history of antibiotics and anti-inflammatory drugs in past 6 months preceding study.
- •d) Periodontally healthy with generalized probing depth less than or equal to 3 mm.
- •e)Radiographic parameters of no signs of crestal bone loss on radiograph.
排除标准
- •Presence of gingivitis and periodontitis b) Presence of Systemic disease c) Presence of bone disease d) History of previous orthodontic treatment e) Smoking habit.
结局指标
主要结局
Changes in the level of Apolipoprotein E
时间窗: T0- Saliva collected at beginning of treatment | T1 - Saliva collected 24 hours after intervention. | T2- Saliva collected after 21 days of intervention | T3 – Saliva collected after 6 months of | intervention
次要结局
- To compare both the groups(T0- Saliva collected at beginning of treatment)