NCT05819372

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 28, 2023

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 19, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

January 2, 2024

Status Verified

December 1, 2023

Enrollment Period

3 months

First QC Date

March 24, 2023

Last Update Submit

December 27, 2023

Conditions

Zygomaticomaxillary Complex Fracture

Outcome Measures

Primary Outcomes (1)

  • Stresses by megapascal (MPa)

    stress on the plate will be measured for each point of application by finite element (FA) software

    immediately after procedure

Study Arms (1)

finite arm

EXPERIMENTAL
Procedure: Zygomaticomaxillary fracture repair

Interventions

Zygomaticomaxillary fracture repairPROCEDURE

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

finite arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • absence of other facial trauma, mandibular condylar fracture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta university

Tanta, Egypt

Location

Related Publications (1)

  • Refahee SM, Khalifa ME, Askar MG, Breshah MN. Role of finite element analysis for selection of single point fixation in zygomaticomaxillary complex fracture. BMC Oral Health. 2024 Jan 4;24(1):15. doi: 10.1186/s12903-023-03822-1.

    PMID: 38178180DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of oral and maxillofacial surgery

Study Record Dates

First Submitted

March 24, 2023

First Posted

April 19, 2023

Study Start

February 28, 2023

Primary Completion

June 1, 2023

Study Completion

June 30, 2023

Last Updated

January 2, 2024

Record last verified: 2023-12

Locations

EG(1)