Schneider Membrane Preservation Combined With In Situ Osteogenesis Strategy: A Feasibility Study of a Modified Maxillary Resection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Bone regeneration status
研究概览
简要总结
This case series study aimed to find out if a new surgical technique that preserves the sinus membrane during upper jaw removal can help patients regenerate bone and recover function better after surgery. The study included two female patients with jaw tumors who were not suitable for or did not want complex reconstruction with tissue flaps. The main questions the study tried to answer were:
Can the preserved sinus membrane help new bone grow spontaneously in the jaw defect area after surgery? Can this new method reduce common complications seen with traditional surgery, such as oronasal fistula and empty nose syndrome? How well can patients recover in terms of chewing, swallowing, speech, and quality of life after the procedure?
In the study, during surgery, the surgeon carefully separated and preserved the sinus membrane from the bone that needed to be removed. After surgery, patients were followed with regular CT scans to check new bone growth. They also underwent tests to measure chewing force, swallowing ability, speech function, and quality of life to evaluate the long-term outcomes of this technique.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Maxillary lesions requiring resection of the jaw as diagnosed by imaging (CT) and pathology;
- •CT shows the lesion only invades the maxilla without involving the maxillary sinus cavity;
- •No nasal septum within the maxillary sinus cavity, with an intact and smooth sinus floor bone wall;
- •No distant metastatic malignant tumors;
- •American Society of Anesthesiologists (ASA) classification I-III, able to tolerate general anesthesia.
排除标准
- •Lesions invading the maxillary sinus mucosa;
- •Presence of septa or severe inflammation in the maxillary sinus;
- •Previous history of head and neck radiotherapy;
- •Coexisting immune system diseases or metabolic bone diseases;
- •Pregnancy or breastfeeding;
- •Any surgical contraindications;
- •Mental illness or inability to comply with follow-up.
研究组 & 干预措施
Traditional Procedure Group
Modified Procedure Group
干预措施: chneiderian Membrane-Preserving (Procedure)
结局指标
主要结局
Bone regeneration status
时间窗: 6 months
Patients were followed up at 1, 3, and 6 months to assess bone formation in the maxillary sinus floor (CT slices used the contralateral first maxillary molar in the surgical area as an anatomical reference for preoperative and postoperative comparison). Specifically, the Planmeca ProMax® 3D tool was used to evaluate bone regeneration, measuring the length in the coronal plane, the length in the sagittal plane, and the height (in mm) on CT scans. The volume of newly formed maxillary sinus floor bone (in cubic millimeters) was calculated to assess the newly generated bone in the maxillary sinus floor.
次要结局
- Postoperative complications(1 year)
研究者
Wenzhao Guan
Attending Physician
Second Hospital of Shanxi Medical University