Biomechanical Effects of Digitally Constructed Subperiosteal Implants

NCT ID: NCT06362057

Last Updated: 2025-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-04

Study Completion Date

2025-07-27

Brief Summary

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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

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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.

Conditions

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Bone Loss

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Titanium framework group

Virtual design for Titanium subperiosteal framework group on atrophied maxilla.

Subperiosteal implant framework

Intervention Type 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

PEEK framework group

Virtual design for PEEK subperiosteal framework group on atrophied maxilla.

Subperiosteal implant framework

Intervention Type 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

PEKK framework group

Virtual design for PEKK subperiosteal framework group on atrophied maxilla.

Subperiosteal implant framework

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Menoufia University

OTHER

Sponsor Role lead

Responsible Party

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Mohammed El-Sawy

lecturer, Department of Prosthetic dental science, principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohammed A. El-Sawy, PhD

Role: STUDY_CHAIR

Menoufia University

Locations

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Mohammed A. El-Sawy

Al Mansurah, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohammed A. El-Sawy, PhD

Role: CONTACT

161314522

Facility Contacts

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Mohammed A. El-Sawy, PhD

Role: primary

161314522

PhD

Role: backup

References

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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.

Reference Type DERIVED
PMID: 40640731 (View on PubMed)

Other Identifiers

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001-130125-017

Identifier Type: -

Identifier Source: org_study_id

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