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NCT06362057 Clinical Trial

Biomechanical Effects of Digitally Constructed Subperiosteal Implants

Bone Loss Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06362057
Other study ID # ADMNF-0020324
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 4, 2024
Est. completion date July 27, 2024

Study information
Verified date April 2024
Source Menoufia University
Contact Mohammed A. El-Sawy, PhD
Phone 161314522
Email Dr_sawy@windowslive.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 9
Est. completion date July 27, 2024
Est. primary completion date June 20, 2024
Accepts healthy volunteers
Gender All
Age group 30 Years to 70 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Egypt Mohammed A. El-Sawy Mansoura

Sponsors (1)
Lead Sponsor Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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