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临床试验/NCT07749638
NCT07749638已完成不适用

Investigating Genetic Biomarkers in the Early Detection of Skeletal Class III Malocclusion: An Observational Study

Cairo University1 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2023年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
93
试验地点
1
主要终点
presence of single nucleotide polymorphism

研究概览

简要总结

Purpose of the Research:

To reveal the genetic cause for the occurrence of Class III malocclusion, or what may be described as a reverse bite (underbite).

Introduction and Detailed Procedures for the Patient (Work Plan):

  1. The volunteer will rinse their mouth with chlorhexidine before taking the swab.
  2. A saliva sample will be collected from the patient using a syringe, along with a frontal facial photograph and a lateral cephalometric X-ray.
  3. DNA / genetic material will be extracted from the sample.
  4. Screening will be conducted for genetic mutations that may be responsible for the occurrence of the underbite.
  5. The photographs and X-rays will be analyzed and compared with the swab results.
  6. This data will be analyzed to determine whether the detected mutations are the cause of the underbite.
  7. The sample will be retained for use in future research studies.

Side Effects, Expected Risk Levels, and Management"

  • Pain: Mild discomfort during swab collection, which does not require any painkillers.
  • Infection/Inflammation: Mild inflammation at the sample site or a secondary bacterial infection; in this case, antibiotics may be prescribed if necessary.
  • Risk Level: Low risk, estimated to be less than 5%.

研究设计

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

入排标准

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

入选标准

  • for Control group:
  • Patients of Egyptian nationality.
  • ANB from 0° to 4.8°.ANB from 0° to 4.8°.
  • Wits appraisal no less than -3.0 mm.
  • Inclusion Criteria for Study group:
  • Patients of Egyptian nationality.
  • ANB (angle between point A, nasion and point B at nasion) angle (point A-nasion point B) of less than 0 degrees.
  • Negative Wits appraisal greater than -3.0 mm.

排除标准

  • The presence of any growth disturbances, syndromes, congenital abnormalities, & endocrine disorders.
  • Patients subjected to previous orthodontic, orthopedic, or orthognathic treatment.
  • Poor quality of radiographic records.
  • Consent form not signed.

研究组 & 干预措施

Study Group

skeletal class III, Negative Wits appraisal greater than -3.0 mm, ANB < 0°

Control Group

skeletal class I, Wits appraisal no less than -3.0 mm, ANB from 0° to 4.8°.

结局指标

主要结局

presence of single nucleotide polymorphism

时间窗: cross-sectional - results are assessed at one point of time (Preintervention)

difference in snps between control and study group

次要结局

  • lateral cephalometric measurements(cross-sectional - results are assessed at one point of time (Preintervention))
  • Frontal photos measurements(cross-sectional - results are assessed at one point of time (Preintervention))

研究者

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

Beshoy Magdy Kamel Moharib

Master's student candidate in orthodontics department

Cairo University

研究点 (1)

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