- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07266896
Patient-specific Finite Element Analysis of Immediate Loading in the Edentulous Maxilla: Comparison of Three Implant Configurations Using Digital Twins.
November 25, 2025 updated by: Centre Hospitalier Universitaire de Nice
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alpes Maritimes
-
Nice, Alpes Maritimes, France, 06000
- CHU de Nice
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Edentulous maxillae, have had full-arch bone reconstruction in order to use the scanner before the bone graft and the scanner after the bone graft and simulate two configurations (all on four and quad zygomatic) on the digital model from the first scanner, and one implant configuration (all on six) on the digital model from the second scanner.
Description
Inclusion Criteria:
- Edentulous maxillae, have had full-arch bone reconstruction
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
At inclusion
|
|
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).
|
At inclusion
|
|
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).
|
At inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accuracy of the digital model digital twin of real patient
Time Frame: At inclusion
|
Scan of his edentulous maxilla
|
At inclusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 2, 2023
Primary Completion (Actual)
November 2, 2023
Study Completion (Actual)
November 2, 2023
Study Registration Dates
First Submitted
November 25, 2025
First Submitted That Met QC Criteria
November 25, 2025
First Posted (Actual)
December 5, 2025
Study Record Updates
Last Update Posted (Actual)
December 5, 2025
Last Update Submitted That Met QC Criteria
November 25, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25Odonto07
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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