Finite Element and z Shap Mini Plate With Lingual Extension

March 21, 2025 updated by: Shaimaa Mohsen, Fayoum University

Finite Element Evaluation of Patient Specific Z-shaped Plate With Lingual Extension Versus Conventional Two Mini Plates for Mandibular Parasymphyseal Fracture Fixation

  • A cone beam CT (CBCT) scan of the patient, will be used to create a 3D scanned image of parasympheseal mandibular fracture
  • 3D images will be introduced to finite element (FA)software to evaluate Stresses (MPa) and Life time (cycle) For each model and determine which plate is the best

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1

Phase

  • Not Applicable

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

- parasymhyseal fracture

Exclusion Criteria:

• absence of other facial trauma, mandibular condylar fracture

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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: z miniplate with lingual extension
Procedure: z mini plate with lingual extension
parasympheseal fracture model fixed with z mini plate with lingual extension
Active Comparator: two mini plate
Procedure: two mini plates
parasympheseal fracture model fixed with conventional 2 mini plates

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
stress on the plate will be measured for each point of application by finite element (FA) software
Time Frame: immediate after the procedure
immediate after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fayoum University

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 (Estimated)

April 27, 2025

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 27, 2025

Study Registration Dates

First Submitted

March 21, 2025

First Submitted That Met QC Criteria

March 21, 2025

First Posted (Actual)

March 28, 2025

Study Record Updates

Last Update Posted (Actual)

March 28, 2025

Last Update Submitted That Met QC Criteria

March 21, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3333

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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