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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • France
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nice

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 2, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 2, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 2, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 25, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 5, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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