Biomechanical Effects of Digitally Constructed Subperiosteal Implants

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: Bone Loss
• Intervention / Treatment: Other: Subperiosteal implant framework

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

• Study Contact: Name: Mohammed A. El-Sawy, PhD; Phone Number: 161314522; Email: Dr_sawy@windowslive.com

Study Locations

• Egypt
  • Mansoura, Egypt, 12345
    • Recruiting
    • Mohammed A. El-Sawy
    • Contact: PhD
    • Contact: Mohammed A. El-Sawy, PhD; Phone Number: 161314522; Email: Dr_sawy@windowslive.com

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

3

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	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

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

Study record dates

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: Titanium; Polyetherketoneketone; Polyethereetherketone
• 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