Finite Element Role in Zygomaticomaxillary Complex (ZMC) Fracture

Sponsor

Fayoum University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05819372

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A cone beam CT (CBCT) scan of the patient, will be used to create a 3D scanned image of ZMC
3D images will be introduced to finite element (FA)software to evaluate Stresses (MPa) and Life time (cycle) For each model and determine which point of fixation is the best
After application this point of fixation on the patient
Finite element analysis will be done again to verify the previous results

Condition or Disease	Intervention/Treatment	Phase
Zygomaticomaxillary Complex Fracture	Procedure: Zygomaticomaxillary fracture repair	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Role of Finite Element Analysis for Selection of Single Point Fixation in Zygomaticomaxillary Complex Fracture

Actual Study Start Date :

Feb 28, 2023

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: finite arm	Procedure: Zygomaticomaxillary fracture repair A cone beam CT (CBCT) scan of the patient will be used to create a 3D scanned image of zygomaticomaxillary complex fracture (ZMC) 3D images will be introduced to finite element (FA) software to evaluate Stresses (MPa), Micromotion (microns), and Life time (cycle) For each model and determine which point of fixation is the best After application this point of fixation on the patient Finite element analysis will be done again to verify the previous results

Arm

Intervention/Treatment

Experimental: finite arm

Procedure: Zygomaticomaxillary fracture repair

A cone beam CT (CBCT) scan of the patient will be used to create a 3D scanned image of zygomaticomaxillary complex fracture (ZMC) 3D images will be introduced to finite element (FA) software to evaluate Stresses (MPa), Micromotion (microns), and Life time (cycle) For each model and determine which point of fixation is the best After application this point of fixation on the patient Finite element analysis will be done again to verify the previous results

Outcome Measures

Primary Outcome Measures

Stresses by megapascal (MPa) [immediately after procedure]
stress on the plate will be measured for each point of application by finite element (FA) software

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Fit to general anesthesia (GA)
Isolated minimally displaced zygomaticomaxillary complex (ZMC) fracture

Exclusion Criteria:

absence of other facial trauma, mandibular condylar fracture

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tanta university	Tanta		Egypt

Sponsors and Collaborators

Fayoum University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shaimaa Mohsen, lecturer of oral and maxillofacial surgery, Fayoum University

ClinicalTrials.gov Identifier:

NCT05819372

Other Study ID Numbers:

R-OS-2-23-3

First Posted:

Apr 19, 2023

Last Update Posted:

Apr 19, 2023

Last Verified:

Apr 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Fractures, Bone

Study Results

No Results Posted as of Apr 19, 2023