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临床试验/NCT07622758
NCT07622758已完成不适用

Retrospective Study on the Application of Tooth-bone Dual-support Osteotomy/Location Plate in "Surgery-first" Orthognathic Treatment

Peking Union Medical College1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年2月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1

研究概览

简要总结

The goal of this observational study is to learn the accuracy of tooth-bone dual-support osteotomy/location guide plate compared with conventional CAD/CAM interocclusal splints in "surgery-first" orthognathic surgeries.

The main question it aims to answer is:

Does the tooth-bone dual-support osteotomy/location guide plate performed better in accuracy? Does the tooth-bone dual-support osteotomy/location guide plate saved operation time? Participants already underwent orthognathic surgeries.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 18 to 40 years old.
  • Diagnosis: Patients treated at Plastic Surgery Hospital, Chinese Academy of Medical Sciences. Diagnosed with dentofacial deformity upon comprehensive evaluation by two senior attending plastic surgeons.
  • Surgical plan: Scheduled for bimaxillary orthognathic surgery, which may be combined with subapical osteotomy of the maxilla and mandible or genioplasty.
  • Treatment protocol: Cases eligible for the surgery-first approach after joint assessment by craniomaxillofacial surgeons and orthodontists. Orthodontists confirm that satisfactory occlusal relationships can be achieved via postoperative orthodontic treatment. Preoperative requirements are as follows: no or mild anterior crowding, flat or shallow Spee's curve, slight incisor inclination, harmonious maxillary and mandibular dental arches, and at least three stable occlusal contacts in the transitional occlusion.
  • Agreement to follow-up and signed informed consent form.

排除标准

  • Presence of comorbid diseases or symptoms that may increase surgical risks or compromise surgical outcomes, as determined by two senior plastic surgeons, including but not limited to hypertension, diabetes, immune thrombocytopenic purpura, and hemoglobin (Hb) ≤ 100 g/L.
  • Body dysmorphic disorder, history of psychiatric disorders, or excessively demanding patients with unrealistic expectations.
  • Facial skeletal tumors.
  • Revision surgery after prior orthognathic procedures.

研究者

发起方
Peking Union Medical College
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiaolei Jin

Dr.

Peking Union Medical College

研究点 (1)

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