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.

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.

Study Overview

• Status: Completed
• Conditions: Sinusitis; Periodontal Disease
• Intervention / Treatment: Device: Scheiderian Membrane Perforation

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon
    • Saint-Joseph University of Beirut

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SMP	Device: Scheiderian Membrane Perforation; Assess endoscopically any Scheiderian membrane perforation while performing transcrestal sinus floor elevation using the densah burs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Perioperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
primary stability achieved by the implants at insertion measured with the insertion torque value, in N.cm	studied in all cases	Perioperative
qualitative pattern of membrane distention, differentiated into either a U-shaped dome or a V-shaped dome	Studies in case of SMP occurrence	Perioperative
time at which the potential perforation occur	Studies in case of SMP occurrence	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	Perioperative

Collaborators and Investigators

• Sponsor: Saint-Joseph University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Actual): March 24, 2026
• Study Completion (Actual): March 24, 2026

Study Registration Dates

• First Submitted: April 1, 2026
• First Submitted That Met QC Criteria: April 14, 2026
• First Posted (Actual): April 21, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: endoscopy; dental implants; osseodensification; sinus floor augmentation; crestal sinus lift; sinus membrane perforation
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Nose Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Periodontal Diseases; Sinusitis
• Other Study ID Numbers: FMD SF 168

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No