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

ConditionMaxillary Diseases

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-75

SponsorWenzhao Guan

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

chneiderian Membrane-Preserving
Procedure/Surgery
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.

Treatment groups

18 Participants

are divided into 2 treatment groups

Group A: Traditional Procedure GroupNo intervention 0 interventions

Group B: Modified Procedure GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

Bone regeneration status

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.

Time frame

6 months

Secondary outcomes

Postoperative complications

One year after surgery, the patient underwent follow-up to detect the occurrence of complications such as oronasal fistula and empty nose syndrome.

Time frame

1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wenzhao Guan

Lead sponsor

Second Hospital of Shanxi Medical University

Sponsor institution

Source ClinicalTrials.gov

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