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Clinical Trials/NCT07266896
NCT07266896
Completed
Not Applicable

Patient-specific Finite Element Analysis of Immediate Loading in the Edentulous Maxilla: Comparison of Three Implant Configurations Using Digital Twins.

Centre Hospitalier Universitaire de Nice1 site in 1 country1 target enrollmentStarted: November 2, 2023Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
1
Locations
1
Primary Endpoint
Stress distribution in the Maxillary Bone

Overview

Brief Summary

Rehabilitation of severely atrophic edentulous maxillae with dental implants pose a significant clinical challenge. Immediate loading in grafted bone is often debated due to concerns about stress distribution and osseointegration. This study aimed to compare stress distribution in the maxilla using three full-arch implant configurations-all-on-four, all-on-six, and quad-zygomatic implants-in a single patient, to determine the safest and most favorable approach for immediate loading in grafted bone. Two CBCT scans from a 64-year-old female patient, before and after bone grafting (allograft with onlay grafting and sinus augmentation), were used to generate three patient-specific finite element models. Each model included the maxilla, implants in the respective configuration, abutments, and a full-arch prosthesis. Von Mises stresses in cortical and cancellous bone, implants, abutments, and prosthesis, as well as maximum bone displacement, were analyzed. Our results demonstrated that the all-on-six configuration provided the most favorable biomechanical outcome, with homogeneous cortical stress distribution, reduced stress in implants and prosthesis, and bone displacement fully compatible with immediate loading in grafted bone. The all-on-four model showed stress peaks at tilted abutments and cantilevers, whereas the quad-zygomatic model distributed implant and abutment stresses efficiently but induced higher cortical bone stresses, still within physiological limits.This patient-specific digital twin study demonstrates that immediate loading in full-arch grafted bone is biomechanically safe and optimal, with the all-on-six configuration providing superior stress distribution. These findings support clinical decision-making for immediate loading protocols and highlight the value of patient-specific FEA in planning complex maxillary rehabilitations.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Retrospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Edentulous maxillae, have had full-arch bone reconstruction

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Stress distribution in the Maxillary Bone

Time Frame: At inclusion

Finite element analysis (FEA) a numerical simulation method that models how mechanical forces affect anatomical structures. This technique visualizes stress, tension, compression and displacement zones in the maxillary bone. Stress values are expressed in megapascals (MPa) and displacements in microns (μm).

Stress distribution in the Implants

Time Frame: At inclusion

Finite element analysis (FEA). This technique visualizes stress, tension, compression and displacement zones in the implant. Stress values are expressed in megapascals (MPa) and displacements in microns (μm).

Stress distribution in the Prosthesis

Time Frame: At inclusion

Finite element analysis (FEA). This technique visualizes stress, tension, compression and displacement zones in the prosthesis. Stress values are expressed in megapascals (MPa) and displacements in microns (μm).

Secondary Outcomes

  • Accuracy of the digital model digital twin of real patient(At inclusion)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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