NCT07099833

Brief Summary

This retrospective observational study aimed to investigate the aetiology and fracture patterns among patients with mandibular condylar fractures (MCF) who were treated at a trauma center in Shiraz, Iran, between 2018 and 2020. A total of 122 patients were included. The study involved collecting data on fracture characteristics, including anatomical location, classification (MacLennan and Loukota systems), angle of fracture lines, and the presence of concomitant maxillofacial injuries. The objective was to examine correlations between these characteristics and demographic or clinical factors such as age, sex, and mechanism of injury.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
122

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 1, 2025

Completed
Last Updated

August 1, 2025

Status Verified

July 1, 2025

Enrollment Period

3 years

First QC Date

June 27, 2025

Last Update Submit

July 29, 2025

Conditions

Keywords

Mandibular Condylar FractureSubcondylar FractureCraniofacial Trauma

Outcome Measures

Primary Outcomes (3)

  • Distribution of mandibular condylar fracture types (MacLennan classification)

    Frequency and percentage of fracture types (Class I-IV) based on MacLennan classification at initial clinical evaluation.

    At initial evaluation (2018-2020)

  • Anatomical location of mandibular condylar fractures

    Distribution of fracture sites: subcondylar, condylar neck, or condylar head based on CT scan classification (Loukota system).

    At initial evaluation (2018-2020)

  • Etiology of mandibular condylar fractures

    Proportion of fractures attributed to road traffic accident, falling, or assault based on patient report.

    At initial evaluation (2018-2020)

Interventions

Azita Sadeghzade

Eligibility Criteria

Age12 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 12 to 65 years with trauma-induced unilateral or bilateral mandibular condylar fractures who were admitted to a trauma center affiliated with Shiraz University of Medical Sciences between January 2018 and December 2020. All included patients had complete clinical and radiographic records and no prior history of condylar fracture.

You may qualify if:

  • Patients diagnosed with unilateral or bilateral mandibular condylar fracture
  • Trauma-related fracture confirmed by clinical and radiographic evaluation
  • Complete medical record and imaging data available
  • Age between 12 and 65 years at the time of trauma

You may not qualify if:

  • History of prior mandibular condylar fracture
  • Incomplete medical or imaging records
  • Patients younger than 12 or older than 65 at time of injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Medical Sciences, Shiraz, Iran.

Shiraz, 1111, Iran

Location

MeSH Terms

Conditions

Mandibular FracturesFacial Injuries

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
100 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor of Oral and Maxillofacial Medicine

Study Record Dates

First Submitted

June 27, 2025

First Posted

August 1, 2025

Study Start

January 1, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

August 1, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations