Clinical trial Recruiting at 1 site Interventional Ages 18 to 75

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

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

Run by Second Hospital of Shanxi Medical University · NCT07320417 · Data updated 2026-11-12

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.

More Maxillary Diseases trials

Quick facts

Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment18 (estimated)
SponsorSecond Hospital of Shanxi Medical University
Academic / other
Locations1 site (Shanxi)
StatusRecruiting
StartedMay 1, 2025
Main results expectedJune 8, 2026
Study endsJune 10, 2026
Registry record updatedJanuary 27, 2026
Trial IDNCT07320417 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • The Second Hospital of Shanxi Medical University
    Shanxi, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.