Condylar FracturesNCT07403708
Retromandibular Transparotid Approach Versus Transmasseteric Anteroparotid Approach for Fixation of Subcondylar Fracture
A study testing transmasseteric anteroparotid approach and transparotid approach in people with Condylar Fractures, run by Alexandria University at 1 site in Egypt.
Trial summary
Background: Condylar fracture is one of mandibular fracture which accounts for 20-35%. It is the most controversial fractures regarding diagnosis and management. For several years, surgeons preferred closed reduction over open reduction to avoid surgical complications. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Condylar Fractures
- What is being tested?
- transmasseteric anteroparotid approach and transparotid approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 30 Dec 2025
- Phase
- Interventional
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients suffering from displaced extracapsular mandibular subcondylar fracture indicated for open reduction including:
- Difficulty of obtaining adequate occlusion by closed method. Radiological signs of the following:
- Deviation of the he fragments from the axis of the ascending ramus in medial or lateral direction more than 10°. (28)
- Shortening of the ascending ramus ≥ 2 mm measured from the roof of glenoid fossa to the inferior border of the ascending ramus of the mandible.
- Dislocation of the condyle from the glenoid fossa.
Who cannot join
- Patients who were not able to follow the information given or to make a decision themselves due to mental or other problems. 2. Patient with undisplaced condylar fractures that doesn't cause malocclusion or loss of facial heightening and can be treated conservatively.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retromandibular Transparotid Approach Versus Transmasseteric Anteroparotid Approach for Fixation of Subcondylar Fracture: Randomized Controlled Clinical Study
Background: Condylar fracture is one of mandibular fracture which accounts for 20-35%. It is the most controversial fractures regarding diagnosis and management. For several years, surgeons preferred closed reduction over open reduction to avoid surgical complications.
Closed reduction may have late complications, the preference started to change towards open treatment. A Transmasseteric Anteroparotid (TMAP) approach for open treatment of condylar fractures overcomes the problems of facial nerve injury of other approaches. Aim: Comparing the Transmasseteric Antroparotid approach(TMAP) to the Transparotid (TP) approach in management of subcondylar fractures regarding the facial nerve affection, parotid fistula, reduction angulation, pain, duration of the surgery, occlusion and patient satisfaction with the scar. Materials and Methods: Twenty patients with subcondylar fracture will be divided randomly into two equal groups. Group1(study group): Transmasseteric Antroparotid approach. Group2 (control group): Retromandibular Transparotid approach. Patients will be followed up for 3 months to assess facial nerve injury, pain, occlusion and patient's scar satisfaction . Results: data will be collected, tabulated and statistically analysed.
- Conditions
- Condylar Fractures
- Being tested
- transmasseteric anteroparotid approach, transparotid approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transmasseteric anteroparotid approachProcedure or surgery
safer approach for condylar fracture
transparotid approachProcedure or surgery
facial nerve and parotid dissection to reach condyle
| Study group | Role | What they receive |
|---|---|---|
| transmasseteric anteroparotid approach | Experimental | Not described Receives: Procedure: transmasseteric anteroparotid approach |
| transparotid approach | Active comparator | Not described Receives: Procedure: transparotid approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
facial nerve injury
Measured: immediate postoperative
Secondary outcomes (1)
approach time
Measured: interaoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start1 Jan 2024
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Condylar FracturesStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mona oraby, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07403708
- Sponsor's protocol ID
- 0841-01/2024
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- 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 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retromandibular Transparotid Approach Versus Transmasseteric Anteroparotid Approach for Fixation of Subcondylar Fracture: Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT07403708
- Acronym / sponsor ID
- 0841-01/2024
- Conditions
- Condylar Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 11 Feb 2026 (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.
Background: Condylar fracture is one of mandibular fracture which accounts for 20-35%. It is the most controversial fractures regarding diagnosis and management. For several years, surgeons preferred closed reduction over open reduction to avoid surgical complications.
Closed reduction may have late complications, the preference started to change towards open treatment. A Transmasseteric Anteroparotid (TMAP) approach for open treatment of condylar fractures overcomes the problems of facial nerve injury of other approaches. Aim: Comparing the Transmasseteric Antroparotid approach(TMAP) to the Transparotid (TP) approach in management of subcondylar fractures regarding the facial nerve affection, parotid fistula, reduction angulation, pain, duration of the surgery, occlusion and patient satisfaction with the scar. Materials and Methods: Twenty patients with subcondylar fracture will be divided randomly into two equal groups. Group1(study group): Transmasseteric Antroparotid approach. Group2 (control group): Retromandibular Transparotid approach. Patients will be followed up for 3 months to assess facial nerve injury, pain, occlusion and patient's scar satisfaction . Results: data will be collected, tabulated and statistically analysed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transmasseteric anteroparotid approach | Experimental | Procedure: transmasseteric anteroparotid approach |
| transparotid approach | Active comparator | Procedure: transparotid approach |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients suffering from displaced extracapsular mandibular subcondylar fracture indicated for open reduction including:
- Difficulty of obtaining adequate occlusion by closed method. Radiological signs of the following:
- Deviation of the he fragments from the axis of the ascending ramus in medial or lateral direction more than 10°. (28)
- Shortening of the ascending ramus ≥ 2 mm measured from the roof of glenoid fossa to the inferior border of the ascending ramus of the mandible.
- Dislocation of the condyle from the glenoid fossa.
Key exclusion criteria (1 listed)
- Patients who were not able to follow the information given or to make a decision themselves due to mental or other problems. 2. Patient with undisplaced condylar fractures that doesn't cause malocclusion or loss of facial heightening and can be treated conservatively.
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 |
|---|---|---|
| transmasseteric anteroparotid approachsafer approach for condylar fracture | Procedure or surgery | transmasseteric anteroparotid approach |
| transparotid approachfacial nerve and parotid dissection to reach condyle | Procedure or surgery | transparotid approach |
Primary outcome
facial nerve injury
Time frame: immediate postoperative
1 secondary outcome
approach time
Time frame: interaoperative
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 12 Feb 2026.
- 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?
A study testing transmasseteric anteroparotid approach and transparotid approach in people with Condylar Fractures, run by Alexandria University at 1 site in Egypt.
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 5 inclusion and 1 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 12 Feb 2026. 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 Egypt. 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?
facial nerve injury (time frame: immediate postoperative). 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 12 Feb 2026.