SinusitisNCT07542275
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.
A study testing Scheiderian Membrane Perforation in people with Sinusitis and Periodontal Disease, run by Saint-Joseph University at 1 site in Lebanon.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sinusitis, Periodontal Disease
- What is being tested?
- Scheiderian Membrane Perforation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Sep 2025to 24 Mar 2026
- Phase
- Interventional
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endoscopic Assessment of Schneiderian Membrane Perforation During Osseodensification-mediated Transcrestal Sinus Floor Elevation With Immediate Implant Placement in Subsinus Bone Height of 4-6 mm: A Pilot Study
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.
- Conditions
- Sinusitis, Periodontal Disease
- Being tested
- Scheiderian Membrane Perforation
- Keywords
- crestal sinus lift, dental implants, endoscopy, osseodensification, sinus floor augmentation, sinus membrane perforation
- Medical subject headings
- Sinusitis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scheiderian Membrane PerforationDevice
Assess endoscopically any Scheiderian membrane perforation while performing transcrestal sinus floor elevation using the densah burs
| Study group | Role | What they receive |
|---|---|---|
| SMP | Experimental | Not described Receives: Device: Scheiderian Membrane Perforation |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of Scheiderian membrane perforation
The primary aim of the present clinical study is to evaluate the incidence of SMP during TSFE with immediate implant placement performed by a trainee surgeon using the osseodensification technique under sinuscopic control in sinuses of comparable contour
Measured: Perioperative
Secondary outcomes (4)
primary stability achieved by the implants at insertion measured with the insertion torque value, in N.cm
studied in all cases
Measured: Perioperative
qualitative pattern of membrane distention, differentiated into either a U-shaped dome or a V-shaped dome
Studies in case of SMP occurrence
Measured: Perioperative
time at which the potential perforation occur
Studies in case of SMP occurrence
Measured: Perioperative
Size of potential perforations, in mm, classified as pinhole <1mm, small >1mm and <2mm, medium >2mm and < 3mm, large >3mm
Studied in case of SMP occurrence
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start1 Sep 2025
- Primary completion24 Mar 2026
- Study completion24 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SinusitisStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot Study
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint-Joseph University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07542275
- Sponsor's protocol ID
- FMD SF 168
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No