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临床试验/NCT05020431
NCT05020431Unknown不适用

Detection of Type I Collagen Fragments in the Gingival Crevicular Fluid and Saliva During Orthodontic Tooth Movement

Alexandria University1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2021年5月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
14
试验地点
1
主要终点
Levels of ICTP in GCF and saliva samples before appliance placement, 24 hours, 3 days, 7 days, 14 days, and 21 days after archwire placement.

研究概览

简要总结

Investigate the levels of type I Collagen fragments ICTP and CTX in GCF and saliva during initial leveling and alignment of the teeth in a sample of adolescents undergoing orthodontic treatment.

详细描述

Type I Collagen fragments ICTP (cross-linked carboxyterminal telopeptide of type 1 collagen) and CTX (C-terminal cross-linked telopeptide of type I collagen) are specific bone resorption biomarkers released in the circulation after osteoclastic bone resorption and collagen degradation and were found to be released in gingival crevicular fluid (GCF) and saliva during metabolic bone diseases and active periodontitis. So the aim of the study is to investigate the levels of ICTP and CTX in GCF and saliva during initial leveling and alignment of the teeth in a sample of adolescents undergoing orthodontic treatment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
13 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • The age ranges from 13-18 years old.
  • Good oral hygiene.
  • Clinical gingival health on the intact periodontium.
  • Permanent dentition.
  • Moderate crowding.
  • Non-extraction treatment plan. If extraction of teeth is required, the treatment plan should allow for postponing extraction after sample collection.

排除标准

  • Systemic diseases associated with loss of periodontal supporting tissues.
  • Metabolic bone diseases and systemic medications affecting bone metabolism.
  • Craniofacial anomalies such as cleft lip and/or palate.
  • Xerostomia.
  • Tobacco-related habits such as smoking, tobacco chewing, etc.

结局指标

主要结局

Levels of ICTP in GCF and saliva samples before appliance placement, 24 hours, 3 days, 7 days, 14 days, and 21 days after archwire placement.

时间窗: 21 days

Measuring the Levels of collagen fragment ICTP in GCF and saliva samples before appliance placement, 24 hours, 3 days, 7 days, 14 days, and 21 days after archwire placement.

Levels of CTX in GCF and saliva samples before appliance placement, 24 hours, 3 days, 7 days, 14 days, and 21 days after archwire placement.

时间窗: 21 days

Measuring the Levels of collagen fragment CTX in GCF and saliva samples before appliance placement, 24 hours, 3 days, 7 days, 14 days, and 21 days after archwire placement.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Omar Tareq

Principal Investigator

Alexandria University

研究点 (1)

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