Schneider Membrane Preservation With In Situ Osteogenesis: A Modified Maxillary Resection Study

Официальное название

Schneider Membrane Preservation Combined With In Situ Osteogenesis Strategy: A Feasibility Study of a Modified Maxillary Resection

Обзор

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.

Вмешательства

• Процедура chneiderian Membrane-Preserving
  1\. Perform preoperative imaging evaluation of the patient to observe the condition of the maxillary sinus bony walls. During surgery, flap the tissue to expose the anterior wall of the maxilla, and create a window in the normal bone area of the anterior wall (approximately 10×15mm in diameter); 5. Carefully insert the maxillary sinus elevation instrument between the maxillary sinus membrane and the maxilla, delicately separate the maxillary sinus membrane while maintaining its integrity, and el

Первичные конечные точки

• Bone regeneration status [Срок оценки: 6 months]

Вторичные конечные точки (1)

• Postoperative complications [Срок оценки: 1 year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Second Hospital of Shanxi Medical University — Shanxi

Публикации

• Guan W, Liu W, Rong S, Han J, Ma Y. A functional Schneiderian membrane-preserving maxillectomy: leveraging mucosal bone-forming potential and clinical effectiveness verification. BMC Oral Health. 2026 Jun 30. doi: 10.1186/s12903-026-09078-9. Online ahead of print. PMID 42380972

Идентификаторы

NCT: NCT07320417 · [2025]YX No. 175

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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