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临床试验/NCT05077878
NCT05077878已完成不适用

Dentine Sialophosphoprotein (DSPP) Quantification for Root Resorption Prediction Using Multivariate Versus Univariate Spectrum Analysis

National University of Malaysia1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年9月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
value of wavelength of DSPP in GCF from child patient severe root resorption

研究概览

简要总结

This study was conducted after obtaining approval from UKM Research Ethics Committee. Gingival Crevicular Fluid (GCF) from Orthodontic and non-orthodontic patients was collected with the consent of patients to detect Dentine sialophosphoprotein. Spectrometry analysis of Gingival Crevicular Fluid was conducted in collaboration with MIMOS Berhad.

详细描述

Thirty patients were recruited having met the following inclusion criteria of (1) good general health, (2) good periodontal health, (3) caries-free, (4) good oral hygiene. The subjects were divided into 3 groups based on a radiographic assessment on the level of root resorption; normal (no root resorption), mild (less than 2 mm), and severe (more than 2 mm). The GCF samples were taken from the permanent central incisors of untreated subjects in the normal control group (n=14), while in the mild group, samples were collected from the permanent central incisors with mild root resorption (<2 mm) in patients undergoing active orthodontic treatment after 6 months with radiographic evidence (mild group, n=5). Child patients with severe root resorption (>2 mm) were those with primary second molars undergoing physiological root resorption (severe group, n=11). The GCF samples were collected from the mesial and the distal gingival crevicular sulcus of the involved teeth using gingival fluid collection strips (Periopaper, Oraflow, Smithtown, N.Y.). The paper strips were placed within the sulcus (intrasulcular method) approximately 1 to 2 mm into the gingival sulcus and left in situ for 60 seconds. Every sample collection was taken 3 times at the same site with one-minute resting intervals to allow GCF to be replenished into the gingival sulcus.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
10 Years 至 30 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • good general health,
  • good periodontal health,
  • caries-free,
  • good oral hygiene

排除标准

  • Consumption of anti-inflammatory drugs and antibiotics

结局指标

主要结局

value of wavelength of DSPP in GCF from child patient severe root resorption

时间窗: 1 month

The absorbance values at a single wavelength at 450 nm

value of wavelength of DSPP in GCF from non-orthodontic patient with no root resorption

时间窗: 1 month

The absorbance values at a single wavelength at 450 nm

value of wavelength of DSPP in GCF from orthodontic patient with mild to moderate root resorption

时间窗: 1 month

The absorbance values at a single wavelength at 450 nm

次要结局

未报告次要终点

研究者

发起方
National University of Malaysia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rohaya Megat Abdul Wahab

Professor

National University of Malaysia

研究点 (1)

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