Mandibular FracturesNCT06333197
Approaches for Open Reduction and Internal Fixation of Mandibular Condylar Fracture
A study testing ORIF through transparotid approach and ORIF through retroparotid approach in people with Mandibular Fractures, run by Assiut University.
Trial summary
The condylar region is the most frequent anatomical site for mandibular fractures . Condylar fractures constitute 25.5% to 35.5% of all mandibular fractures. The mandibular condyle fracture is a type of fracture that affects the condyle, which is the knuckle-like projection of the mandible (lower jaw) that articulates… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Mandibular Fractures
- What is being tested?
- ORIF through transparotid approach and ORIF through retroparotid approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 1 Jul 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- ALL Patients diagnosed with Extra Capsular Fracture of Mandibular Condyle amenable for surgery.
Who cannot join
- 1. Open Laceration in the condylar region. 2. Concomitant traumatic Facial Nerve injury. 3. Previous Surgery in Retromandibular region. 4. Severe Obese patients 5. Patients Refusing Surgery.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Comparative Study Between the Retromandibular Transparotid Approach and Retromandibular Retroparotid Approach for Open Reduction and Internal Fixation of Mandibular Condylar Fracture.
The condylar region is the most frequent anatomical site for mandibular fractures .
Condylar fractures constitute 25.5% to 35.5% of all mandibular fractures. The mandibular condyle fracture is a type of fracture that affects the condyle, which is the knuckle-like projection of the mandible (lower jaw) that articulates with the temporal bone to form the temporomandibular joint (TMJ).
Read the detailed description
Several approaches have been used for condylar fracture including intraoral, preauricular, submandibular and retromandibular approaches.
The selection of the appropriate surgical approach for condylar neck fracture represents a controversy.
The purpose of this Study is to Compare the outcomes and effectiveness between the retromandibular transparotid approach and retromandibular retroparotid approach for treatment of Condylar Fracture of Mandible.
- Conditions
- Mandibular Fractures
- Being tested
- ORIF through transparotid approach, ORIF through retroparotid approach
- Keywords
- Mandibular Condylar fracture, Approaches for mandibular fractures, Transparotid, Retromandibular, Comparative study, Retroparotid
- Medical subject headings
- Mandibular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORIF through transparotid approachProcedure or surgery
The Retromandibular Transparotid approach is a surgical method used to access structures in the parotid gland region by making an incision behind the mandible.
ORIF through retroparotid approachProcedure or surgery
Also called ORIF through the Modified Blair Incision
The Retromandibular Retroparotid approach, also known as the Modified Blair Incision, is a surgical technique used to access structures within the parotid gland region by creating an incision behind the mandible and extending it into the parotid region.
| Study group | Role | What they receive |
|---|---|---|
| transparotid approch | Experimental | Patients who diagnosed with extra capsular fracture of mandibular condyle will undergo Retromandibular transparotid approch Receives: Procedure: ORIF through transparotid approach |
| Retroparotid approch | Experimental | Patients who diagnosed with extra capsular fracture of mandibular condyle will undergo Retromandibular retroparotid approch Receives: Procedure: ORIF through retroparotid approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial nerve injury
Incidence of Facial Nerve Injury Following the Manoeuvre. ( Temporary or Permanent )
Measured: Up to 6 months
Operative time
The duration of the operation
Measured: Up to 3 hours
Secondary outcomes (3)
Fracture stability
Measure the status of bone after reduction
Measured: Up to 3 Months
Mouth opening
Maximal inter incisor opening
Measured: Up to 3 Months
Other Complication related to the Approach
Salivary Fistula, Sialocele, Freys Syndrome
Measured: Up to 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
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.
- More trials run by Assiut 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
- Model description
- ALL Patients diagnosed with Extra Capsular Fracture of Mandibular Condyle amenable for surgery.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Mahmoud Hussien Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06333197
- Sponsor's protocol ID
- Mandibular condylar fracture
- Status last verified
- Jul 2024
- First submitted
- 27 Dec 2023
- Last updated
- 30 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between the Retromandibular Transparotid Approach and Retromandibular Retroparotid Approach for Open Reduction and Internal Fixation of Mandibular Condylar Fracture.
- ClinicalTrials.gov ID
- NCT06333197
- Acronym / sponsor ID
- Mandibular condylar fracture
- Conditions
- Mandibular Fractures
- Keywords
- Mandibular Condylar fracture, Approaches for mandibular fractures, Transparotid, Retromandibular, Comparative study, Retroparotid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 27 Mar 2024 (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.
The condylar region is the most frequent anatomical site for mandibular fractures .
Condylar fractures constitute 25.5% to 35.5% of all mandibular fractures. The mandibular condyle fracture is a type of fracture that affects the condyle, which is the knuckle-like projection of the mandible (lower jaw) that articulates with the temporal bone to form the temporomandibular joint (TMJ).
Detailed description
Several approaches have been used for condylar fracture including intraoral, preauricular, submandibular and retromandibular approaches.
The selection of the appropriate surgical approach for condylar neck fracture represents a controversy.
The purpose of this Study is to Compare the outcomes and effectiveness between the retromandibular transparotid approach and retromandibular retroparotid approach for treatment of Condylar Fracture of Mandible.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- ALL Patients diagnosed with Extra Capsular Fracture of Mandibular Condyle amenable for surgery.
| Arm | Type | Receives |
|---|---|---|
| transparotid approch | Experimental | Procedure: ORIF through transparotid approachPatients who diagnosed with extra capsular fracture of mandibular condyle will undergo Retromandibular transparotid approch |
| Retroparotid approch | Experimental | Procedure: ORIF through retroparotid approachPatients who diagnosed with extra capsular fracture of mandibular condyle will undergo Retromandibular retroparotid approch |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- ALL Patients diagnosed with Extra Capsular Fracture of Mandibular Condyle amenable for surgery.
Key exclusion criteria (1 listed)
- 1. Open Laceration in the condylar region. 2. Concomitant traumatic Facial Nerve injury. 3. Previous Surgery in Retromandibular region. 4. Severe Obese patients 5. Patients Refusing Surgery.
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 |
|---|---|---|
| ORIF through transparotid approachThe Retromandibular Transparotid approach is a surgical method used to access structures in the parotid gland region by making an incision behind the mandible. | Procedure or surgery | transparotid approch |
| ORIF through retroparotid approachAlso: ORIF through the Modified Blair IncisionThe Retromandibular Retroparotid approach, also known as the Modified Blair Incision, is a surgical technique used to access structures within the parotid gland region by creating an incision behind the mandible and extending it into the parotid region. | Procedure or surgery | Retroparotid approch |
Primary outcome
Facial nerve injury
Time frame: Up to 6 months
Incidence of Facial Nerve Injury Following the Manoeuvre. ( Temporary or Permanent )
Operative time
Time frame: Up to 3 hours
The duration of the operation
3 secondary outcomes
Fracture stability
Time frame: Up to 3 Months
Mouth opening
Time frame: Up to 3 Months
Other Complication related to the Approach
Time frame: Up to 6 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing ORIF through transparotid approach and ORIF through retroparotid approach in people with Mandibular Fractures, run by Assiut University.
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 1 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: status not confirmed, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mustafa Mahmoud Hussien (+201015750092 ext. +201140308095, Urfavdash@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Facial nerve injury (time frame: Up to 6 months). The study lists 2 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 30 Jul 2024.