進行中(不再收案) NCT04635865

3D打印患者專屬手術接骨板與傳統手術接骨板於下頜骨重建之比較

未指定不適用

目標:本隨機對照臨床試驗旨在評估使用3D打印患者專屬鈦金屬手術接骨板與傳統接骨板進行電腦輔助下頜骨重建之手術準確度與效率。 待驗證假設:研究人員假設,與傳統手術接骨板相比,3D打印患者專屬手術接骨板可提升電腦輔助下頜骨重建之手術準確度與效率。

適應症:Mandibular Neoplasms、Maxillary Neoplasms、Dentofacial Deformities

收案條件

納入條件

  • Age greater than 18 years, of both gender;
  • Provision of signed and dated informed consent form;
  • Diagnosed with maxillofacial benign or malignant tumours or inflammatory or congenital diseases and indicated for computer-assisted jaw surgery;
  • Primary or secondary reconstruction with autogenous bony free flaps or graft will be needed;
  • Titanium plates will be used for internal fixation for the reconstruction surgery;
  • Agree to comply with follow-up procedures.

排除條件

  • Patients who are pregnant;
  • Patients who have medically compromised conditions and cannot tolerate the surgery;
  • Systemic conditions or diseases that violate the normal bone healing;
  • Patients who are unable to take the preoperative and postoperative CT/CBCT scans;
  • Patients who are unable to have a two-week period prior to surgery, for virtual surgery simulation, 3D patient-specific surgical plate design and fabrication.

收案條件維持 ClinicalTrials.gov 原始英文登錄資料,實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源:ClinicalTrials.gov,每兩週自動更新,最後同步:2026年10月8日。