NCT06899568

Brief Summary

  • 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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

March 21, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 28, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

April 27, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2025

Completed
Last Updated

March 28, 2025

Status Verified

March 1, 2025

Enrollment Period

1 month

First QC Date

March 21, 2025

Last Update Submit

March 21, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

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

    immediate after the procedure

Study Arms (2)

z miniplate with lingual extension

EXPERIMENTAL
Procedure: z mini plate with lingual extension

two mini plate

ACTIVE COMPARATOR
Procedure: two mini plates

Interventions

parasympheseal fracture model fixed with z mini plate with lingual extension

z miniplate with lingual extension

parasympheseal fracture model fixed with conventional 2 mini plates

two mini plate

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- parasymhyseal fracture

You may not qualify if:

  • absence of other facial trauma, mandibular condylar fracture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Mandibular Fractures

Condition Hierarchy (Ancestors)

Jaw FracturesMaxillofacial InjuriesFacial InjuriesCraniocerebral TraumaTrauma, Nervous SystemNervous System DiseasesSkull FracturesFractures, BoneWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

March 21, 2025

First Posted

March 28, 2025

Study Start

April 27, 2025

Primary Completion

June 1, 2025

Study Completion

June 27, 2025

Last Updated

March 28, 2025

Record last verified: 2025-03