跳至主要内容
临床试验/CTRI/2025/04/084458
CTRI/2025/04/084458尚未招募2 期

A comparative evaluation of gingival crevicular fluid & salivary biomarkers & bisphenol A level with outsourced, inhouse and direct printed aligner for orthodontic tooth movement an invivo study

Dr Padmapriya P1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年4月19日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To find assosciation between salivary inflammatory biomarkers and Bis phenol A levels among different types of aligners used for tooth movement and its implications on health in South Kerala populations.

研究概览

简要总结

This comparative in vivo study was conducted to determine if there is any difference in the level of expression of inflammatory biomarkers such as IL-1 beta, TNF alpha as well as Bis-phenol A  (BPA) release when different types of aligners are used in similar malocclusion on randomly selected 60 participants attending the out-patient clinic of Department of Orthodontics and Dentofacial Orthopedics, Sri Sankara Dental Collage, Varkala , Trivandrum.

BPA is a known endocrine disrupter. BPA increases the risk of cancer, diabetes, heart disease and hyperactivity in children.  The collected GCF samples were transferred to 0.5 ml Eppendorf tubes and analysed using high performance liquid chromatography - mass spectrometry.  As well as 10 ml  of saliva is collected into polypropylene tubes with protease inhibitors and ELIZA was used to screen the sample for cytokines. The harmonious interplay of osteoclast differentiation and cytokine activation is fundamental to the success of bone remodelling, ultimately ensuring effective and controlled tooth movement. So by conducting this study we can improve the treatment efficiency and can reduce the unwanted side effects caused by BPA.

研究设计

研究类型
Interventional
分配方式
Adaptive randomization, such as minimization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 26.00 Year(s)(—)
性别
All

入选标准

  • Patients who are healthy without any medical conditions and congenital anomaly
  • Patients who do not undergone previous orthodontic treatment or orthognathic surgeries.

排除标准

  • NO OTHER SYSTEMIC DISEASES NO PERIODONTAL DISEASES NO OTHER MEDICAL DISEASES.

结局指标

主要结局

To find assosciation between salivary inflammatory biomarkers and Bis phenol A levels among different types of aligners used for tooth movement and its implications on health in South Kerala populations.

时间窗: 30 days

次要结局

  • To compare the level of biomarkers & bisphenol A amounts between Outsourced & In house & Directly Printed Aligners(30 days)

研究者

发起方
Dr Padmapriya P
申办方类型
Other [self]

研究点 (1)

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