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

Official title

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

Overview

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.

Interventions

• Procedure 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

Primary outcome measures

• Bone regeneration status [Time frame: 6 months]

Secondary outcome measures (1)

• Postoperative complications [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• The Second Hospital of Shanxi Medical University — Shanxi

Publications

• 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

Identifiers

NCT: NCT07320417 · [2025]YX No. 175

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗