Maxillary DiseasesNCT07320417
Schneider Membrane Preservation With In Situ Osteogenesis: A Modified Maxillary Resection Study
A study testing chneiderian Membrane-Preserving in people with Maxillary Diseases, run by Wenzhao Guan at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Maxillary Diseases
- What is being tested?
- chneiderian Membrane-Preserving
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 10 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Hospital of Shanxi Medical University
Shanxi
Wenzhao Guan, 13700542824, guanwenzhao_111@163.com
About this study
Official title: 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.
- Conditions
- Maxillary Diseases
- Being tested
- chneiderian Membrane-Preserving
- Medical subject headings
- Maxillary Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chneiderian Membrane-PreservingProcedure or surgery
- 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.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Procedure Group | No intervention | Not described |
| Modified Procedure Group | Active comparator | Not described Receives: Procedure: chneiderian Membrane-Preserving |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start1 May 2025
- Primary completion8 Jun 2026 (estimated)
- Study completion10 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maxillary DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenzhao Guan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wenzhao Guan, Second Hospital of Shanxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07320417
- Sponsor's protocol ID
- [2025]YX No. 175
- Status last verified
- Jan 2026
- First submitted
- 22 Dec 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guan W, Liu W, Rong S, Han J, Ma Y. A functional Schneiderian membrane-preserving maxillectomy: leveraging mucosal bone-forming potential and clinical effectiveness verification. BMC Oral Health. 2026 Jun 30;26(1):1404. doi: 10.1186/s12903-026-09078-9.
PubMed 42380972
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Schneider Membrane Preservation Combined With In Situ Osteogenesis Strategy: A Feasibility Study of a Modified Maxillary Resection
- ClinicalTrials.gov ID
- NCT07320417
- Acronym / sponsor ID
- [2025]YX No. 175
- Conditions
- Maxillary Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Wenzhao GuanUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 8 Jun 2026 (estimated)
- Study completion
- 10 Jun 2026 (estimated)
- First posted
- 6 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Procedure Group | No intervention | – |
| Modified Procedure Group | Active comparator | Procedure: chneiderian Membrane-Preserving |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chneiderian Membrane-Preserving1. 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. | Procedure or surgery | Modified Procedure Group |
Primary outcome
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.
1 secondary outcome
Postoperative complications
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Derived from this study: PubMed 42380972Guan W, Liu W, Rong S, Han J, Ma Y. A functional Schneiderian membrane-preserving maxillectomy: leveraging mucosal bone-forming potential and clinical effectiveness verification. BMC Oral Health. 2026 Jun 30;26(1):1404. doi: 10.1186/s12903-026-09078-9.
Related trials for Maxillary Diseases
Not yet recruitingPhase 3
Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
Pulpitis
Enrolling by invitation
Discision as Acceleration Method in Canine Retraction in Orthodontics With Aligner and Fixed Appliances in Young Adults a Split Mouth Study
Bimaxillary Protrusion, Class II Div 1 Malocclusion
Not yet recruiting
Effect of Customized Versus Stock Healing Abutments on Peri-Implant Soft Tissue
Peri-Implantitis
Recruiting
Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
Alveolar Bone Loss, Sinus Floor Augmentation
Recruiting
The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
Alveolar Bone Loss, Edentulism Nos
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chneiderian Membrane-Preserving in people with Maxillary Diseases, run by Wenzhao Guan at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenzhao Guan (13700542824, guanwenzhao_111@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone regeneration status (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07320417, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.