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临床试验/CTRI/2024/04/066214
CTRI/2024/04/066214尚未招募4 期

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.

Dr Taanvi Miglani1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年4月30日最近更新:

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

发起方
Dr Taanvi Miglani
申办方类型
Other [Self Funded]
责任方
Principal Investigator
主要研究者

Dr Taanvi Miglani

Manav Rachna Dental College

研究点 (1)

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