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Recruiting NCT06362057

Biomechanical Effects of Digitally Constructed Subperiosteal Implants

Observational Bone Loss

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Subperiosteal implant framework.
Who it may be relevant to
Registry conditions: Bone Loss. Basic parameters: 30 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

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.

Interventions

  • 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

Primary outcome measures

  • bone loss under the implants [Time frame: 10-15 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Other

Study locations

Egypt · 1 center
  • Mohammed A. El-Sawy — Al Mansurah

Publications

  • El-Sawy MA, El-Khatib B, Borg HS, Khater MT. Biomechanical effects of digitally constructed titanium, modified polyetheretherketone, and polyetherketoneketone subperiosteal implants on atrophied maxilla: a finite element analysis. BMC Oral Health. 2025 Jul 10;25(1):1142. doi: 10.1186/s12903-025-06426-z. PMID 40640731

Identifiers

NCT: NCT06362057 · 001-130125-017

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗