目标:本随机对照临床试验旨在评估使用3D打印患者专属钛金属手术接骨板与传统接骨板进行电脑辅助下颌骨重建之手术准确度与效率。 待验证假设:研究人员假设,与传统手术接骨板相比,3D打印患者专属手术接骨板可提升电脑辅助下颌骨重建之手术准确度与效率。
适应症:Mandibular Neoplasms、Maxillary Neoplasms、Dentofacial Deformities
入组条件
纳入标准
- 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.
排除标准
- 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.
入组条件维持 ClinicalTrials.gov 原始英文登记资料,实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源:ClinicalTrials.gov,每两周自动更新,最后同步:2026年10月8日。