Endoscopic Assessment of Schneiderian Membrane Perforation During Osseodensification-mediated Tra… (NCT07542275) | Clinical Trial Compass
CompletedNot Applicable
Endoscopic Assessment of Schneiderian Membrane Perforation During Osseodensification-mediated Transcrestal Sinus Floor Elevation With Graftless Immediate Implant Placement in Subsinus Bone Height of 4-6 mm: A Pilot Study.
Lebanon6 participantsStarted 2025-09-01
Plain-language summary
This present study will evaluate Schneiderian membrane perforation rates using osseodensification in TSFE with simultaneous graftless implant placement, under sinuscopic control monitored by an ENT specialist.
An endoscopic evaluation will be continuously conducted throughout the surgical procedure. TSFE will be performed using Densah burs without the addition of bone graft material, followed by implant placement. The rationale behind this approach is to monitor the response of the Schneiderian membrane and assess the effects of Densah burs on membrane distention and the occurrence of SMP.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* males and females over 21 years of age;
* partial edentulism in the posterior maxilla involving 2 or more adjacent teeth in the premolar-molar area;
* teeth at the intended implant sites must have been extracted or lost at least 9 months before the date of implant surgery;
* sinus floor with a relatively flat contour confirmed on baseline CBCT;
* bucco-palatal sinus width (distance between the buccal and palatal walls at 10-mm apical level comprising the residual alveolar crest ) 8-12 mm confirmed on baseline CBCT to minimize the risk of SMP during surgery (Stacchi et al. 2022);
* sinus membrane thickness ≤ 2 mm;
* subsinus residual bone height (RBH) 4-6 mm at the intended implant sites and bucco-palatal bone width allowing implant placement without bone augmentation procedures.
Exclusion Criteria:
* systemic conditions contraindicating implant surgery;
* pregnancy or lactation;
* ongoing or history of pathologies or medications affecting bone metabolism;
* ongoing or history of head and neck irradiation;
* oral inflammatory and autoimmune diseases;
* presence of osseous lesions or persistent infections in the planned implant sites;
* previous bone augmentation surgery;
* uncontrolled periodontal diseases;
* heavy smoking (\> 10 cigarettes/day);
* history of sinus surgery;
* presence of intrasinus bony septa that could affect membrane elevation and distention; and
* ongoing or history of rhinitis or sinusitis.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.