Biomechanical Effects of Digitally Constructed Subperiosteal Implants

March 25, 2025 updated by: Mohammed El-Sawy, Menoufia University

Biomechanical Effects of Digitally Constructed Subperiosteal Implants From Different Materials With Different Prosthetic Superstructures on Atrophied Maxilla: A Finite Element Analysis

Subperiosteal implants were first introduced in 1940 and then used worldwide for the treatment of edentulous maxilla or mandible with advanced bone atrophy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

With the advancement of digital technology for the fabrication of materials and the emerging of new materials, subperiosteal implants can be fabricated from a wide variety of materials, and there is a lack of evidence regarding which material could be suitable.

Study Type

Observational

Enrollment (Estimated)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Mansoura, Egypt, 12345
        • Recruiting
        • Mohammed A. El-Sawy
        • Contact:
          • PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

This is a three dimentional finite element analysis

Description

Inclusion Criteria:

  • A 3D image of an edentulous maxilla bone derived from a computed tomography scan of an adult patient.
  • Maxilla with Cawood and Howell class 4 or 5 classification

Exclusion Criteria:

  • A 2D image of an edentulous maxilla bone
  • A non atrophied maxilla

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Titanium framework group
Virtual design for Titanium subperiosteal framework group on atrophied maxilla.
Other: Subperiosteal implant framework

A 3D image of an edentulous maxilla bone will be derived from a computed tomography scan of an adult patient and saved as "stl" data. The solid geometry of the maxilla, including the cortical and spongious bone, was rebuilt from the "stl" data into the Digital Imaging and Communications in Medicine (DICOM) format with 3D-Doctor (Able Software Corp., MA, USA).

With the Boolean method, force loading will be achieved between prosthetic parts, subperiosteal implant screws and bone tissues
PEEK framework group
Virtual design for PEEK subperiosteal framework group on atrophied maxilla.
Other: Subperiosteal implant framework

A 3D image of an edentulous maxilla bone will be derived from a computed tomography scan of an adult patient and saved as "stl" data. The solid geometry of the maxilla, including the cortical and spongious bone, was rebuilt from the "stl" data into the Digital Imaging and Communications in Medicine (DICOM) format with 3D-Doctor (Able Software Corp., MA, USA).

With the Boolean method, force loading will be achieved between prosthetic parts, subperiosteal implant screws and bone tissues
PEKK framework group
Virtual design for PEKK subperiosteal framework group on atrophied maxilla.
Other: Subperiosteal implant framework

A 3D image of an edentulous maxilla bone will be derived from a computed tomography scan of an adult patient and saved as "stl" data. The solid geometry of the maxilla, including the cortical and spongious bone, was rebuilt from the "stl" data into the Digital Imaging and Communications in Medicine (DICOM) format with 3D-Doctor (Able Software Corp., MA, USA).

With the Boolean method, force loading will be achieved between prosthetic parts, subperiosteal implant screws and bone tissues

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bone loss under the implants
Time Frame: 10-15 years
amount of bone loss which appears on a modeling process, The modeling process will be completed using a three-dimensional modeling software. A three-dimensional mesh consisting of 556,365 nodes and 2972,897 elements with VRMesh Studio (VirtualGrid Inc, Bellevue City, WA, USA) will used in the program.
10-15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Menoufia University

Investigators

  • Study Chair: Mohammed A. El-Sawy, PhD, Menoufia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2024

Primary Completion (Estimated)

May 20, 2025

Study Completion (Estimated)

July 27, 2025

Study Registration Dates

First Submitted

April 8, 2024

First Submitted That Met QC Criteria

April 8, 2024

First Posted (Actual)

April 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 27, 2025

Last Update Submitted That Met QC Criteria

March 25, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 001-130125-017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The IPD is upon request from the corresponding author

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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