Biomechanical Effects of Digitally Constructed Subperiosteal Implants

Recruiting

• Conditions: Bone Loss
• Interventions: Other: Subperiosteal implant framework

• Registration Number: NCT06362057
• Lead Sponsor: Menoufia University

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.

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.

Study Timeline

• Study Start: 2024-04-04
• Study First Submitted: 2024-04-08
• Study First Submitted QC: 2024-04-08
• Study First Posted: 2024-04-12
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-27
• Primary Completion: 2025-05-20
• Study Completion: 2025-07-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 9

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PEKK framework group	Subperiosteal implant framework	Virtual design for PEKK subperiosteal framework group on atrophied maxilla.
PEEK framework group	Subperiosteal implant framework	Virtual design for PEEK subperiosteal framework group on atrophied maxilla.
Titanium framework group	Subperiosteal implant framework	Virtual design for Titanium subperiosteal framework group on atrophied maxilla.

Primary Outcome Measures

Name	Time	Method
bone loss under the implants	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.

Trial Locations

Locations (1)

Mohammed A. El-Sawy; 🇪🇬 Mansoura, Egypt