Evaluation of Tenting the Schneiderian Membrane of the Maxillary Sinus Using Titanium Mesh.

NCT07035236 | Recruiting

• 1 other identifier: 967/2025
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Twenty posterior maxillary edentulous sites requiring open sinus augmentation for staged dental implant placement will be studied. Group I (study group) the maxillary sinus membrane will be elevated using titanium mesh fixed by bone screws. Group II (control group) will have stainless steel screws/pins placed bucco-palatally to maintain the elevated membrane and stabilize the formed blood clot. Platelet rich fibrin (PRF) will be placed at the site of elevated membrane in both groups.

Conditions

Maxillary Sinus Floor Augmentation

Keywords

Tenting; Schneiderian membrane

Outcome Measures

Primary Outcomes (2)

• Histological evaluation of gained bone quality

  Using Hematoxin and Eosin stains

  6 months

• Radiographic Bone gain after maxillary sinus lift

  Using Cone Beam CT

  6 months

Study Arms (2)

Titanium mesh group (study group)

EXPERIMENTAL

Group I (study group) the Schneiderian membrane will be elevated using titanium mesh fixed by screws

Procedure: maxillary sinus lifting

Screws group (control group)

ACTIVE COMPARATOR

Group II (control group) will have stainless steel screws/pins placed bucco-palatally to maintain the elevated membrane and stabilize the formed blood clot

Procedure: Maxillary sinus lifting

Interventions

Maxillary sinus lifting PROCEDURE

The schneiderian membrane will be tented using titanium mesh.

Titanium mesh group (study group)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult male/female patients with age interval 18:60 years old.
• Patients with one or more teeth requiring implant supported dental restoration in atrophic maxilla.
• Alveolar bone height less than 5 mm at the defective site.
• Good oral hygiene.
• Patient's consensual agreement to be enrolled in the study.

You may not qualify if:

• Medically compromised patients with conditions contraindicating surgery (eg. uncontrolled diabetics, bisphosphonate intake, radio or chemotherapy).
• Patients with active infection at or related to the site of surgery (eg. acute sinusitis).
• Heavy smokers.
• Patients not indicated for an implant supported restoration at the time of enrollement (eg. active/untreated periodontal disease). (Patients developing any medical condition that interferes with the outcomes after enrolment in the study will be excluded).

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Suez Canal University

Ismailia, 41511, Egypt

RECRUITING

Central Study Contacts

Hedra Sherif Michael

CONTACT

+201226182970; Hedra_sherif@dent.suez.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Freelance dentist

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 25, 2025
• Study Start: July 15, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)