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

NCT ID: NCT07035236

Last Updated: 2025-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-31

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Maxillary Sinus Floor Augmentation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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Titanium mesh group (study group)

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

Group Type EXPERIMENTAL

maxillary sinus lifting

Intervention Type PROCEDURE

The schneiderian membrane will be tented using titanium mesh.

Screws group (control group)

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

Group Type ACTIVE_COMPARATOR

Maxillary sinus lifting

Intervention Type PROCEDURE

The Schneiderian membrane will be elevated using bone screws

Interventions

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maxillary sinus lifting

The schneiderian membrane will be tented using titanium mesh.

Intervention Type PROCEDURE

Maxillary sinus lifting

The Schneiderian membrane will be elevated using bone screws

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Suez Canal University

OTHER

Sponsor Role lead

Responsible Party

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Hedra sherif

Freelance dentist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Suez Canal University

Ismailia, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Hedra Sherif Michael

Role: CONTACT

+201226182970

Facility Contacts

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Hedra Sherif Kamel Michael, Bachelor's

Role: primary

+201226182970

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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967/2025

Identifier Type: -

Identifier Source: org_study_id

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