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

NCT07042958 | Not Yet Recruiting DMC

• 1 other identifier: the number obtain at end study
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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

Conditions

Sinus Lifting

Outcome Measures

Primary Outcomes (1)

• Gained bone height

  6month

Study Arms (2)

Study group

EXPERIMENTAL

Procedure: zirconia membrane

control group):

EXPERIMENTAL

Procedure: control group

Interventions

zirconia membrane PROCEDURE

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

Study group

control group PROCEDURE

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

control group):

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Fayoum University: lead

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Aliaa Shaban Mohamed

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: June 29, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 29, 2025

Record last verified: 2025-06