Biomechanical Effects of Digitally Constructed Subperiosteal Implants

NCT06362057 | Recruiting

• 1 other identifier: 001-130125-017
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bone Loss

Keywords

Polyetherketoneketone; Titanium; Polyethereetherketone

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Titanium framework group

Virtual design for Titanium subperiosteal framework group on atrophied maxilla.

Other: Subperiosteal implant framework

PEEK framework group

Virtual design for PEEK subperiosteal framework group on atrophied maxilla.

Other: Subperiosteal implant framework

PEKK framework group

Virtual design for PEKK subperiosteal framework group on atrophied maxilla.

Other: Subperiosteal implant framework

Interventions

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

PEEK framework group; PEKK framework group; Titanium framework group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a three dimentional finite element analysis

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Mohammed A. El-Sawy

Al Mansurah, 12345, Egypt

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Mohammed A. El-Sawy, PhD

  Menoufia University

  STUDY CHAIR

Central Study Contacts

Mohammed A. El-Sawy, PhD

CONTACT

161314522; Dr_sawy@windowslive.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer, Department of Prosthetic dental science, principle investigator

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 12, 2024
• Study Start: April 4, 2024
• Primary Completion: May 20, 2025
• Study Completion: July 27, 2025
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)