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NCT Number: NCT06362057

Biomechanical Effects of Digitally Constructed Subperiosteal Implants

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

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Key information

Conditions

Bone Loss Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mohammed A. El-Sawy

Al Mansurah, 12345, Egypt

Location status: Recruiting

Location contact

Mohammed A. El-Sawy, PhD

CONTACT

[email protected]

161314522

PhD

CONTACT

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Subperiosteal implant framework

Other

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

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohammed A. El-Sawy, PhD

CONTACT

[email protected]

161314522

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 12, 2024
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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