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.

NCT07542275 | Completed DMC

• 1 other identifier: FMD SF 168
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sinusitis; Periodontal Disease

Keywords

crestal sinus lift; dental implants; endoscopy; osseodensification; sinus floor augmentation; sinus membrane perforation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• primary stability achieved by the implants at insertion measured with the insertion torque value, in N.cm

  Perioperative

• qualitative pattern of membrane distention, differentiated into either a U-shaped dome or a V-shaped dome

  Perioperative

• time at which the potential perforation occur

  Perioperative

• Size of potential perforations, in mm, classified as pinhole <1mm, small >1mm and <2mm, medium >2mm and < 3mm, large >3mm

  Perioperative

Study Arms (1)

SMP

EXPERIMENTAL

Device: Scheiderian Membrane Perforation

Interventions

Scheiderian Membrane Perforation DEVICE

Assess endoscopically any Scheiderian membrane perforation while performing transcrestal sinus floor elevation using the densah burs

SMP

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saint-Joseph University: lead

Study Sites (1)

Saint-Joseph University of Beirut

Beirut, Lebanon

Location

MeSH Terms

Conditions

Sinusitis; Periodontal Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot Study

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 21, 2026
• Study Start: September 1, 2025
• Primary Completion: March 24, 2026
• Study Completion: March 24, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)