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OpenTrials
Completed

NCT Number: NCT07266896

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nice

Nice, Alpes Maritimes, 06000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Edentulous maxillae, have had full-arch bone reconstruction

Exclusion criteria

  • None

Treatment and study plan

numerical study

Other

CBTS Scans (Cone Beam Computed Tomography) perform as part of routine care

Primary outcomes

  1. 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).

  2. 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).

  3. 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

  1. Accuracy of the digital model digital twin of real patient

    Time frame: At inclusion

    Scan of his edentulous maxilla

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 5, 2025
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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