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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 18 (estimated) |
| Sponsor | Second Hospital of Shanxi Medical University Academic / other |
| Locations | 1 site (Shanxi) |
| Status | Recruiting |
| Started | May 1, 2025 |
| Main results expected | June 8, 2026 |
| Study ends | June 10, 2026 |
| Registry record updated | January 27, 2026 |
| Trial ID | NCT07320417 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
- Study coordinator: Wenzhao Guan
- Email: guanwenzhao_111@163.com
- Phone: 13700542824
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Comparing patient satisfaction and dental health in maxillectomy patients using different obturator types
This study tests which type of dental device, made with advanced technology or traditional methods, helps people who have had part of their upper jaw removed feel more comfortable and keep their teeth healthier.
-
Single-surgery Bone Ring Technique for Sinus Lift and Dental Implant in the Back of the Upper Jaw
This study tests a one-step Bone Ring Technique to lift the sinus and place a dental implant in patients with very thin upper jaw bone.
-
Myo Munchee versus Oral Motor Therapy to improve upper-jaw growth and mouth muscle function in young children
This will see if the Myo Munchee mouth device works better than standard oral motor therapy to improve upper-jaw development and mouth muscle function in children ages 3 to 5.
-
Using clear aligners to expand the upper dental arch in children with cleft lip and palate
This study is testing if clear aligners can help expand the upper jaw in children aged 6-8 with cleft lip and palate.
-
Impact of flapless piezoincision on periodontal health during orthodontic treatment
This study is testing if a new technique for orthodontic treatment without cutting the gums can improve gum health better than two types of grafting in adults with dental issues.
-
Anatomy and imaging of the alveolar antral artery canal using CBCT
This study tests how well cone-beam CT can show the alveolar antral artery canal and its variations in scans taken for other dental reasons.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.