跳至主要内容
临床试验/NCT07365085
NCT07365085已完成不适用

Whole Versus Segmented In-House 3D Mandibular Guides for Mandibular Reconstruction Using Free Fibular Flaps: A Randomized Clinical Trial

Indonesia University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2023年6月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
1
主要终点
FACIAL SYMMETRY

研究概览

简要总结

Three-dimensional (3D) printing is increasingly used in surgery to help doctors plan and perform complex operations with greater accuracy. In this study, the investigators used 3D-printed jaw models to assist in rebuilding the lower jaw (mandible) after tumor removal, using bone taken from the lower leg in a procedure called a free fibular flap.

The investigators compared two types of 3D-printed mandibular guides. One used a complete model of the patient's healthy mandible to guide reconstruction, while the other rebuilt the jaw by dividing the leg bone into planned segments and fitting them precisely into the jaw defect. All 3D design and printing were performed in-house by the surgical team using free computer software.

After surgery, the investigators evaluated facial symmetry using standardized photographs taken before surgery and three months afterward. Both techniques helped surgeons achieve good reconstruction results. However, the segmented model produced more consistent facial symmetry, while results from the whole-mandible model varied more between patients.

Overall, this study shows that in-house 3D printing is a practical and affordable tool for jaw reconstruction surgery. Although both approaches were effective, segmented models may offer more reliable results. Larger studies are needed to confirm these findings and improve future patient care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients undergoing segmental mandibular reconstruction with a free fibular flap.
  • Mandibular defects resulting from benign tumors, malignant tumors, trauma, or osteonecrosis requiring reconstruction.
  • Availability of preoperative high-resolution CT imaging suitable for virtual surgical planning and 3D modeling.
  • Agreed and signed the consent forms

排除标准

  • Contraindications to free fibular flap harvest (e.g., significant peripheral vascular disease, prior fibular surgery).
  • History of previous mandibular reconstruction or major maxillofacial surgery altering baseline anatomy.
  • Preexisting severe facial asymmetry unrelated to the mandibular defect.
  • Inadequate imaging data or incomplete medical records.
  • Incomplete or poor-quality postoperative photographs preventing accurate asymmetry measurement.

研究组 & 干预措施

SEGMENTED MODEL

Experimental

Segmented 3D Mandibular Model.

干预措施: 3D-printed surgical guide - segmented model (Device)

WHOLE MANDIBLE MODEL

Active Comparator

Whole 3D Mandibular Model.

干预措施: 3D-printed surgical guide - whole mandible model (Device)

结局指标

主要结局

FACIAL SYMMETRY

时间窗: From enrollment to 1 month postoperatively

Postoperative assessment of facial symmetry was performed using clinical photographs and plain radiograph of the head (AP) taken 1 month after surgery. The facial asymmetry index (AI) was calculated using the formula: AI (%) = (R - L)/(R + L) × 100%, based on cephalometric landmarks including sella-nasion (Sn), angle of the mouth (Am), and soft tissue pogonion (Po) (Figure 3), in accordance with the method described by Nakamura et al.⁴. This index represents the proportional difference between the right and left sides of each landmark relative to total facial width, expressed as a percentage. Higher AI values indicate greater facial asymmetry.

次要结局

未报告次要终点

研究者

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

Kristaninta Bangun

Kristaninta Bangun

Indonesia University

研究点 (1)

Loading locations...

相似试验