Evaluation of Customized Zirconia Membrane in Direct Sinus Lifting With Simultaneous Implant Placement: (Randomized Control Trial)

NCT ID: NCT07042958

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2026-07-01

Brief Summary

Modern dental implantology offers solutions for patients with edentulism in the maxillary arch, where sinus pneumatization and alveolar ridge atrophy are common. This requires sinus floor elevation and bone grafting for implant placement. Techniques like the lateral window approach and osteotome-mediated sinus floor elevation aim to achieve the necessary vertical bone height for implants. Autogenous bone grafts have been the gold standard but have limitations like donor site morbidity and graft volume loss, leading to the exploration of alternatives. Membranes, such as resorbable collagen or titanium-reinforced materials, are commonly used in these procedures but have limitations related to customization, cost, and failure rates.Recent studies have suggested that placing implants directly into the sinus without grafting material can stimulate bone formation, leveraging blood clots to activate bone-forming cells. Zirconia, a ceramic material known for its bioinertness and mechanical strength, is being explored for its potential in sinus lift procedures. Customized 3D zirconia membranes may offer a solution to enhance bone formation and soft tissue integration during sinus lifts.This study aims to evaluate the effect of using customized zirconia membranes in sinus lift procedures with simultaneous implant placement, comparing bone height outcomes with conventional sinus lifts without membranes

Detailed Description

Modern dental implantology offers solutions for patients with edentulism in the maxillary arch, where sinus pneumatization and alveolar ridge atrophy are common. This requires sinus floor elevation and bone grafting for implant placement. Techniques like the lateral window approach and osteotome-mediated sinus floor elevation aim to achieve the necessary vertical bone height for implants. Autogenous bone grafts have been the gold standard but have limitations like donor site morbidity and graft volume loss, leading to the exploration of alternatives. Membranes, such as resorbable collagen or titanium-reinforced materials, are commonly used in these procedures but have limitations related to customization, cost, and failure rates.Recent studies have suggested that placing implants directly into the sinus without grafting material can stimulate bone formation, leveraging blood clots to activate bone-forming cells. Zirconia, a ceramic material known for its bioinertness and mechanical strength, is being explored for its potential in sinus lift procedures. Customized 3D zirconia membranes may offer a solution to enhance bone formation and soft tissue integration during sinus lifts.This study aims to evaluate the effect of using customized zirconia membranes in sinus lift procedures with simultaneous implant placement, comparing bone height outcomes with conventional sinus lifts without membranes Objectives: The study will assess bone height after sinus lift with customized zirconia membranes versus conventional sinus lift without membranes.

Methods: A randomized clinical trial will compare two groups: one using a customized zirconia membrane and implant placement, and the other receiving the procedure without the membrane. Preoperative assessments will include CBCT and CAD-guided planning, followed by implantation and postoperative monitoring to assess bone height, density, and implant stability.

Conditions

Sinus Lifting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Study group

Group Type: EXPERIMENTAL

zirconia membrane

Intervention Type: PROCEDURE

Patients with atrophic maxilla will undergo a direct sinus lift procedure, utilizing a customized zirconia membrane for tenting, along with simultaneous implant placement.

control group):

Group Type: EXPERIMENTAL

control group

Intervention Type: PROCEDURE

Patients with atrophic maxilla will undergo a direct sinus lift procedure, using tenting with simultaneous implant placement.

Interventions

zirconia membrane

Patients with atrophic maxilla will undergo a direct sinus lift procedure, utilizing a customized zirconia membrane for tenting, along with simultaneous implant placement.

Intervention Type: PROCEDURE

control group

Patients with atrophic maxilla will undergo a direct sinus lift procedure, using tenting with simultaneous implant placement.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

I. ASA physical status I and II. II. Patient with healthy maxillary sinus free from any pathology. III. The edentulous ridges are covered with optimal thickness of Mucoperiosteum with no signs of inflammation, ulceration or scar tissue.

IV. Occlusion showed sufficient inter arch space for future prosthesis.

Exclusion Criteria

General contraindications to implant surgery. I. Untreated gingivitis, periodontitis. II. Patient with maxillary sinusitis. III. Smoker patient. IV. Patient with parafunctional habits. V. Subjected to irradiation in the head and neck area less than 1 year before implantation.

VI. Pregnant or nursing.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fayoum University

OTHER

Sponsor Role: lead

Responsible Party

Aliaa Shaban Mohamed

Aliaa Shaban Mohamed

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

the number obtain at end study

Identifier Type: -

Identifier Source: org_study_id