Preserving the sinus (Schneiderian) membrane to help bone regrow after upper-jaw removal

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

This work tests whether keeping the sinus membrane in place during upper-jaw removal helps new bone grow and improves chewing, swallowing, and speech for people with maxillary tumors who cannot or do not want complex flap reconstruction.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Second Hospital of Shanxi Medical University (Academic / other)
• Locations: 1 site (Shanxi)
• Trial ID: NCT07320417 on ClinicalTrials.gov

What this trial studies

This is a small case series in which surgeons preserved the Schneiderian (sinus) membrane while removing diseased portions of the maxilla in two female patients. The preserved membrane was left in situ to see whether it would support spontaneous bone formation in the postoperative defect. Patients were followed with serial CT scans to document new bone growth and were evaluated for complications such as oronasal fistula and empty nose syndrome as well as functional outcomes like chewing, swallowing, speech, and quality of life. The series focused on patients whose tumors did not invade the sinus cavity and who were unsuitable for or declined complex reconstructive flaps.

Who should consider this trial

Good fit: Ideal candidates are people with maxillary lesions limited to the bone (no sinus cavity invasion), an intact sinus floor without septa or severe sinus inflammation, no distant metastases, ASA class I–III, and who can tolerate general anesthesia.

Not a fit: Patients whose lesions invade the sinus mucosa, who have septa or severe sinus inflammation, prior head and neck radiotherapy, immune or metabolic bone disease, pregnancy, or who require or prefer complex flap reconstruction are unlikely to benefit from this technique.

Why it matters

Potential benefit: If successful, this approach could enable spontaneous bone regeneration after maxillectomy and reduce the need for complex flap reconstruction and related complications.

How similar studies have performed: Similar membrane-preservation and in situ bone regeneration approaches have only limited prior reporting and remain largely experimental with a few case reports suggesting promise but no large trials confirming effectiveness.

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.

Where this trial is running

Shanxi

• The Second Hospital of Shanxi Medical University — Shanxi, China (Recruiting)

Study contacts

• Study coordinator: Wenzhao Guan

Conditions Maxillary Diseases