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临床试验/NCT06392204
NCT06392204
已完成
不适用

Assessment of Mandibular CAD/CAM Angle Fracture Reduction/Plate Guide and Customized 3D Grid Plate Versus Champy's Technique (A Randomized Controlled Trial)

Cairo University1 个研究点 分布在 1 个国家目标入组 24 人2023年10月7日

概览

阶段
不适用
干预措施
CAD/CAM patient specfifc fracture reduction/plate guide and customized 3D grid plate
疾病 / 适应症
Mandibular Fractures
发起方
Cairo University
入组人数
24
试验地点
1
主要终点
Guide accuracy in repositioning of the fractured segments and in comparison to the preoperative 3D virtual surgical plan.
状态
已完成
最后更新
23天前

概览

简要总结

This proposed study aims at creating a computer designed patient specific device and titanium plates, that are 3D manufactured in accordance to a preoperative computer aided virtual surgical procedure, aiming to obtain proper alignment of fractured segments of the lower jaw and restore proper teeth positioning therefore overcoming the possible complications of the conventional methods.

Recruited participants will be randomly allocated to a treatment groupp, whether the novel method group or a standard treatment group.

Preoperative panoramic radiograph and a Computed tomography scan will be obtained for each patient.

Surgical procedure will be conducted unde general anesthetic. Medications will be prescribed after surgery and instructions will be given to each patient.

Follow up will be on a weekly basis for the first 6 weeks followed by a followup visit once a month for 6 months.

Postoperative panoramic radiograph and a Computed tomography scan will be obtained at 1 week after the surgical procrdure and again 6 months later.

Digital data obtained from computed tomography scans along with clinical data will be analysed and studied to determine the accuracy of the computer aided device and for comparison with the standard method of treatment.

注册库
clinicaltrials.gov
开始日期
2023年10月7日
结束日期
2025年9月18日
最后更新
23天前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Arwa Louay Ali Hosni

Principal investigator

Cairo University

入排标准

入选标准

  • Patients with unilateral mandibular angle fracture with or without associated mandibular fractures in need of open reduction and internal fixation.
  • Patients above 18 years old
  • Sufficient dentition to reproduce the occlusal relationships
  • Patient's consent to participate

排除标准

  • Patients with comminuted mandibular angle fracture(s)
  • Patients with any systemic disease that may affect normal healing
  • Patients undergoing chemotherapy or radiotherapy related to the head and neck region
  • Intra-bony lesions in the fracture area that may interfere with proper anatomical reduction.

研究组 & 干预措施

Custom made reduction guides and 3D grid plates

Mandibular angle fracture reduction and fixation using digitally designed and fabricated patient specific fracture reduction/plate positioning guide and customized 3D grid plate

干预措施: CAD/CAM patient specfifc fracture reduction/plate guide and customized 3D grid plate

Stock titanium plates

Mandibular angle fracture reduction and fixation using a single superior border 2.0 miniplate

干预措施: Champy's techqniue

结局指标

主要结局

Guide accuracy in repositioning of the fractured segments and in comparison to the preoperative 3D virtual surgical plan.

时间窗: Outcome will be assessed with preoperative CT (T1-Week 1)immediate postoperative CT at (T3-Week 3)

Accuracy of postoperative reduction by superimposition of 3D CT data on a 3D specialized software

次要结局

  • Postoperative occlusion(Outcome will be assessed clinically at T2 (Week 2) and T3 (Week 3))

研究点 (1)

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