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

January 23, 2026 updated by: Wenzhao Guan

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Traditional Procedure Group
Active Comparator: Modified Procedure Group
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 elevate the membrane to the required height.

6. Place a wet gauze between the elevated membrane and the maxilla to protect the Schneiderian membrane, use an ultrasonic osteotome or reciprocating saw to remove the pathological tissue, and confirm negative margins intraoperatively with frozen section.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone regeneration status
Time Frame: 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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complications
Time Frame: 1 year
One year after surgery, the patient underwent follow-up to detect the occurrence of complications such as oronasal fistula and empty nose syndrome.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wenzhao Guan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2025

Primary Completion (Estimated)

June 8, 2026

Study Completion (Estimated)

June 10, 2026

Study Registration Dates

First Submitted

December 22, 2025

First Submitted That Met QC Criteria

January 5, 2026

First Posted (Actual)

January 6, 2026

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 23, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • [2025]YX No. 175

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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