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临床试验/KCT0008094
KCT0008094招募中未知

A prospective, single-group, single-organ researcher's clinical trial to evaluate the stability and effectiveness of patient-specific bone extensors combining patient-specific bone fixation and ready-made bone extensors in patients who need bone elongation in the jawbone

Chung-Ang Univerisity Hospital0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症

试验速览

阶段
未知
状态
招募中
发起方
入组人数
20

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional Study

入排标准

年龄范围
5(Year) 至 49(Year)(—)
性别
All

入选标准

  • 1. Patients who are scheduled to visit the dentist at Chung-Ang University Hospital and undergo surgery at Chung-Ang University Hospital.
  • 2. Patients who need to re-position, enlargement, or bone reconstruction of the jaw face bone due to birth defects, trauma, tumors, or excessive plastic surgery.
  • 3. Patients who need to re-position, dilatation, or bone reconstruction of the jaw face bone due to skeletal or dental malocclusion.
  • 4. Patients between the ages of 5 and under 50
  • 5. Patients who maintain good oral hygiene.
  • 6. A person who voluntarily agrees to participate in a clinical trial and is willing to comply with the test plan

排除标准

  • 1. A person with uncontrolled metabolic diseases (e.g., diabetes, osteomalacia, thyroid disease)
  • 2. Those who are taking or are planning to take drugs that may affect bone metabolism
  • ? Bisphosphonate, Recombinant human parathyroid hormone (rhPTH), Denosumab, etc
  • 3. Those who have uncontrolled gingivitis, periodontitis, and dental caries
  • 4. A person with a severe heart disease or severe liver dysfunction
  • 5. A person who has an infectious disease with a risk of recurrence
  • 6. A person who has blood diseases (leukaemia, hemophilia, sepsis, etc.)
  • 7. Those who cannot stop taking steroids and anticoagulants before surgery
  • 8. A person who cannot discontinue systemic adrenocortical hormones or anabolic steroids for three months after surgery
  • 9. A person with osteomalacia or Paget disease
  • 10. A person who has experience of receiving radiation treatment at the surgical site
  • 11. Those who are allergic to implant materials
  • 12. Patients with syphilis and severe epilepsy
  • 13. Those who are substance abusers or alcoholics
  • 14. Smokers
  • 15. Where the tester determines that participation in the clinical trial is inappropriate because it may affect other, ethical or clinical trial results
  • ? Specific reasons are stated in the case record

研究者

发起方
Chung-Ang Univerisity Hospital

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