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No observed perforation rate is established for the exact 4–5 mm pilot described in this title. A related Saint-Joseph University trial record, NCT07542275, describes a six-participant pilot with eligibility of 4–6 mm residual bone height (RBH), but its indexed title and range do not exactly match this topic, and the record supplies planned outcomes rather than observed results. Separate endoscopic studies offer context, not a substitute result for that pilot.
Does the exact 4–5 mm pilot have published results?
The available record does not establish that the study named in this article title is the same study as registry entry NCT07542275. The registry entry is indexed as a Saint-Joseph University pilot in Beirut, Lebanon, with 4–6 mm RBH eligibility, rather than the title’s 4–5 mm range. It is therefore best treated as a related record, not a confirmed match.
NCT07542275 is indexed as completed, with a study completion date of March 24, 2026, and a last update of May 1, 2026. Completion status is not the same as publication of findings: the surfaced record describes the study plan but provides no observed outcome values. In particular, it does not provide a membrane-perforation rate that can be attributed to the exact 4–5 mm pilot.
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What the related pilot was designed to assess
The registry describes a single-group interventional pilot targeting six participants. It evaluates transcrestal sinus floor elevation using osseodensification, simultaneous graftless implant placement, and continuous endoscopic monitoring by an ear, nose and throat specialist. The record names Densah burs and says no bone graft material is used.
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Its planned primary outcome is the incidence of Schneiderian membrane perforation. Planned secondary outcomes include insertion torque at implant placement, the qualitative shape of the elevated membrane dome (U-shaped or V-shaped), when any perforation occurs, and perforation size categories. These are planned measurements, not reported findings. The record also lists sinus contour and width and membrane characteristics among eligibility considerations, so its planned sample should not be read as representing every sinus anatomy within the stated RBH range.
What endoscopic monitoring can—and cannot—show
Endoscopic assistance can give the clinician direct visual information during crestal sinus elevation and may help identify a membrane tear and its timing. That is different from proving that the membrane remained intact throughout the procedure, or that visualization prevents a tear. A 2018 report by Samy Elian and Khaled Barakat cautioned: “Intact crestal sinus floor elevation can never be guaranteed under endoscopic monitoring especially with thin irregular membranes.”
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Membrane thickness and stretchability were emphasized by those authors as relevant factors. The planned registry outcomes also distinguish timing and perforation size, which matter because a single yes-or-no incidence figure would not describe when a tear occurred or how extensive it was. No results from the related registry record are available here to show how often any of these events occurred during osseodensification-mediated elevation.
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Small studies using different approaches can illustrate the kind of evidence available, but none supplies the missing outcome for the exact pilot. Their rates should not be pooled or transferred to the registry population.
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| Study | Participants and approach | Reported findings | How to interpret them |
|---|---|---|---|
| Elian et al., 2025 | 20 patients with 4–7 mm RBH; randomized comparison of conventional and endoscopic-assisted crestal sinus lift. | Membrane perforation was reported in 33% of the conventional group and 10% of the endoscopic-assisted group (p=0.582). Mean surgical time was 15.4±2.22 minutes for conventional treatment and 27.3±2.00 minutes for endoscopic-assisted treatment. | The perforation-rate difference was not statistically significant in this small study. The authors said potential benefits should be weighed against additional time and cost. The study did not report the outcome of the exact osseodensification pilot. |
| Elian and Barakat, 2018 | 12 patients with 3–5 mm bone height below the sinus membrane. | No perforation was reported in 83.33% of cases; two minor perforations were reported (16.67%), both detected from the crestal endoscopic view. | This is a separate small report; its results do not establish a rate for the related registry pilot or for osseodensification specifically. |
| Garbacea et al., 2012 | Cadaver pilot involving sinus elevations. | Overall perforation was reported in 40% of elevations, with endoscopic findings attributed to instrumentation, graft insertion, and implant placement at different rates. | These are cadaver findings, not a patient perforation rate, and the procedures differ from the requested pilot. |
In the 2025 comparison, bone density increased from 609.55±108.71 HU postoperatively to 878.38±114.60 HU at six months. This is a study-specific measurement, not evidence that endoscopic assistance or osseodensification produced the same change in another patient group.
How to read the evidence for a 4–5 mm site
RBH is one part of the clinical picture, not a guarantee that two cases are comparable. The related registry’s 4–6 mm eligibility overlaps the requested 4–5 mm range, but overlap does not establish that the records describe the same study or that any eventual result would apply uniformly to all patients in that range. Membrane characteristics and sinus anatomy are also relevant factors in the record and the separate clinical literature.
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- Do not quote a pilot rate: the related registry lists an intended primary outcome but no observed incidence figure.
- Keep the comparator studies separate: the 2025 trial, 2018 report, and 2012 cadaver study differ in design, population, and procedure.
- Distinguish detection from prevention: endoscopic visualization may reveal a perforation; the evidence presented here does not establish that it guarantees an intact membrane.
- Consider procedural trade-offs: in the 2025 study, endoscopic-assisted treatment took longer on average, while its observed perforation-rate difference was not statistically significant.
What a useful report of the pilot would need to provide
To answer the title’s question, a results report would need to identify the study unambiguously and state the enrolled population, including the RBH range actually analyzed. It should report the number of perforations and the denominator, how perforations were detected and categorized, and when they occurred. It should also clarify whether cases used graftless simultaneous implant placement and continuous endoscopic monitoring as described in NCT07542275. Without those observed data and a confirmed title-to-record match, an exact pilot result cannot responsibly be inferred.
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