Mandibular FracturesNCT07099833
Aetiology and Pattern of 122 Patients With Mandibular Condylar Fracture
An observational study of Mandibular Fractures and Facial Injuries, run by Azita Sadeghzade at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mandibular Fractures, Facial Injuries
- What is being tested?
- Azita Sadeghzade
- How many people
- 122 participants
- Where
- 1 siteIran
- Study dates
- 1 Jan 2018to 31 Dec 2020
- How long will I take part?
- 100 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- History of prior mandibular condylar fracture
- Incomplete medical or imaging records
- Patients younger than 12 or older than 65 at time of injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aetiology and Pattern of Mandibular Condylar Fractures: A Retrospective Cohort Study of 122 Patients
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.
Read the detailed description
This is a retrospective cohort study conducted at a major trauma center affiliated with Shiraz University of Medical Sciences, Iran. The study enrolled patients diagnosed with unilateral or bilateral mandibular condylar fractures between January 2018 and December 2020. Data were extracted from clinical records and radiographic evaluations. Fractures were classified according to the MacLennan and Loukota systems, and relevant demographic and injury-related information was recorded. No interventions were administered as part of this registry. All procedures were conducted under approval from the institutional ethics committee. The primary aim was to investigate patterns in fracture characteristics and their associations with trauma mechanisms and patient demographics.
- Conditions
- Mandibular Fractures, Facial Injuries
- Being tested
- Azita Sadeghzade
- Keywords
- Mandibular Condylar Fracture, Subcondylar Fracture, Craniofacial Trauma
- Medical subject headings
- Mandibular Fractures, Facial Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azita SadeghzadeOther
Azita Sadeghzade
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: At initial evaluation (2018-2020)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start1 Jan 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 122 participants (actual)
- Target duration
- 100 Days
Sponsor and investigators
- Lead sponsor
- Azita Sadeghzade
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Azita Sadeghzade, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07099833
- Sponsor's protocol ID
- IR.SUMS.DENTAL.REC.1399.120
- Status last verified
- Jul 2025
- First submitted
- 27 Jun 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aetiology and Pattern of Mandibular Condylar Fractures: A Retrospective Cohort Study of 122 Patients
- ClinicalTrials.gov ID
- NCT07099833
- Acronym / sponsor ID
- IR.SUMS.DENTAL.REC.1399.120
- Conditions
- Mandibular Fractures, Facial Injuries
- Keywords
- Mandibular Condylar Fracture, Subcondylar Fracture, Craniofacial Trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Azita SadeghzadeUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 1 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a retrospective cohort study conducted at a major trauma center affiliated with Shiraz University of Medical Sciences, Iran. The study enrolled patients diagnosed with unilateral or bilateral mandibular condylar fractures between January 2018 and December 2020. Data were extracted from clinical records and radiographic evaluations. Fractures were classified according to the MacLennan and Loukota systems, and relevant demographic and injury-related information was recorded. No interventions were administered as part of this registry. All procedures were conducted under approval from the institutional ethics committee. The primary aim was to investigate patterns in fracture characteristics and their associations with trauma mechanisms and patient demographics.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 100 Days
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- History of prior mandibular condylar fracture
- Incomplete medical or imaging records
- Patients younger than 12 or older than 65 at time of injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azita SadeghzadeAzita Sadeghzade | Other | – |
Primary outcome
Distribution of mandibular condylar fracture types (MacLennan classification)
Time frame: At initial evaluation (2018-2020)
Frequency and percentage of fracture types (Class I-IV) based on MacLennan classification at initial clinical evaluation.
Anatomical location of mandibular condylar fractures
Time frame: At initial evaluation (2018-2020)
Distribution of fracture sites: subcondylar, condylar neck, or condylar head based on CT scan classification (Loukota system).
Etiology of mandibular condylar fractures
Time frame: At initial evaluation (2018-2020)
Proportion of fractures attributed to road traffic accident, falling, or assault based on patient report.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mandibular Fractures and Facial Injuries, run by Azita Sadeghzade at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of mandibular condylar fracture types (MacLennan classification) (time frame: At initial evaluation (2018-2020)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.