Fracture of Condylar ProcessNCT04860427
Trapezoidal Condylar Plate (TCP) in Treatment of Subcondylar Fracture
A study testing trapezoidal condylar plate and two miniplates in people with Fracture of Condylar Process, run by Alexandria University at 1 site in Egypt.
Trial summary
Background: Condylar fracture is a common mandibular fracture which accounts for 25-40%. Nowadays the preference started to change towards open reduction because of the late complications that might happen in case of closed treatment. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Fracture of Condylar Process
- What is being tested?
- trapezoidal condylar plate and two miniplates
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jun 2019to 15 Sep 2021
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1- Medically fit patients free from relevant conditions that contraindicate surgery.
- 2- Patients with age ranged from 20-40 years old. 3- 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 fragment from the axis of the ascending ramus in medial or lateral direction more than 10°.(22)
- 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.(22)
- Dislocation of the condyle from the glenoid fossa.(48)
Who cannot join
- 1. Patients who were not able to follow the information given or to make a decision themselves due to mental or other problems.
- 2. Any absolute contraindication for surgery. 3. 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.
Egypt1 site, 1 recruiting
- Recruiting
Mona Oraby
Alexandria, 25588
mona oraby, ass. lect., 01000775330, drmonasamy@gmail.com
About this study
Official title: Trapezoidal Condylar Plate (TCP) Versus Two Miniplates in Treatment of Subcondylar Fracture
Background: Condylar fracture is a common mandibular fracture which accounts for 25-40%. Nowadays the preference started to change towards open reduction because of the late complications that might happen in case of closed treatment.
A Transmasseteric Anteroparotid (TMAP) approach for open reduction and internal fixation of condylar fractures overcomes the problems of difficult access and facial nerve injury risk of other conventional approaches.
Different plating options are available for internal fixation of the condyle and subcondylar region. Trapezoidal Condylar Plates (TCP) specifically developed for the osteosynthesis of low and high subcondylar fracture. These plates were designed to closely follow the tensile strain lines along the rim of the sigmoid notch anteriorly combined with a posterior arm to parallel the condylar axis free of harmful bending strains.
Read the detailed description
Background: Condylar fracture is a common mandibular fracture which accounts for 25-40%. It is the most controversial fractures regarding diagnosis and management.
For several years, closed reduction has been preferred over open reduction to avoid surgical complications. Nowadays the preference started to change towards open reduction because of the late complications that might happen in case of closed treatment.
A Transmasseteric Anteroparotid (TMAP) approach for open reduction and internal fixation of condylar fractures overcomes the problems of difficult access and facial nerve injury risk of other conventional approaches.
Different plating options are available for internal fixation of the condyle and subcondylar region. Trapezoidal Condylar Plates (TCP) specifically developed for the osteosynthesis of low and high subcondylar fracture. These plates were designed to closely follow the tensile strain lines along the rim of the sigmoid notch anteriorly combined with a posterior arm to parallel the condylar axis free of harmful bending strains.
Aim: Our aim in this study is to assess the use of TCP in the subcondylar fracture in comparison to the use of conventional two miniplates method.
Materials and methods: This prospective randomized clinical trial will enroll 20 patients with subcondylar fracture indicated for open reduction and internal fixation. Group A will undergo fixation with TCP and group B will have two miniplates fixation. Both groups will have Transmasseteric Anteroparotid approach.
Results: The results of the two groups will be compared clinically and radiographically.
Keywords: Subcondylar fracture, Trapezoidal condylar plate, two miniplates, open treatment for condyle, geometric subcondylar plates, transmasseteric anteroparotid approach.
- Conditions
- Fracture of Condylar Process
- Being tested
- trapezoidal condylar plate, two miniplates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trapezoidal condylar plateDevice
trapezoidal condylar plate open reduction and fixation
two miniplatesDevice
two miniplates open reduction and fixation
| Study group | Role | What they receive |
|---|---|---|
| Trapezoidal condylar plate | Active comparator | Trapezoidal condylar plate open reduction and internal fixation of subcondylar fractures Receives: Device: trapezoidal condylar plate |
| two miniplates | Active comparator | two miniplates open reduction and internal fixation of subcondylar fractures Receives: Device: two miniplates |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of functional mandibular movement between the two groups
the change mandibular movement in mm
Measured: preopertive, 1 week, 1month , 3 months , 6months
comparison of occlusion between the two groups
the change in occlusion intercuspation assessed visually by the surgeon and by asking the patient
Measured: preopertive, 1 week, 1month , 3 months , 6months
comparison of helikmo index between the two groups
the change in helikmo index score
Measured: preopertive, 1 week, 1month , 3 months , 6months
comparison in pain between the two groups
the change in pain value with Visual analogue Scale With a visual analogue scale (VAS) with values from 0 (no pain) to 10 (strongest pain or discomfort)
Measured: preopertive, 1 week, 1month
comparison in ramus height shortening between the two groups
radiographically: assess the adequacy of reduction by th change in ramus height in mm
Measured: 1 day, 3 months, 6 months.
comparison in condylar angulation between the two groups
radiographically: assess the adequacy of reduction by measuring the change in condylar angulation
Measured: 1 day, 3 months, 6 months.
bone density change comparison between the two groups
assessment with CT in Hounsfield value measurements.
Measured: 1 day postoperative, 1month and 3months
Secondary outcomes (3)
Transmasseteric Anteroparotid surgical approach
To evaluate the Transmasseteric Anteroparotid surgical approach for the subcondylar fracture regarding the time taken to reach the fracture line and convenience of the approach.
Measured: intraopertive
the stress on plates by using finite element analysis
stress values (Mpa) were obtained in this study for each of the two models during load application
Measured: immediate postopertive
the displacement (micromotion)
the amount of vertical displacement induced around the fracture surface (µm)
Measured: immediate postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start10 Jun 2019
- Primary completion1 Sep 2021 (estimated)
- Study completion15 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture of Condylar ProcessStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mona oraby, Alexandria University
- Investigators
- nagy el prince, professor, Study chair, oral and maxillofacial surgery, alexanderia university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04860427
- Sponsor's protocol ID
- IRB NO 00010556-IORG 0008839
- Status last verified
- Jul 2021
- First submitted
- 8 Apr 2021
- Last updated
- 22 Jul 2021
- 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 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trapezoidal Condylar Plate (TCP) Versus Two Miniplates in Treatment of Subcondylar Fracture
- ClinicalTrials.gov ID
- NCT04860427
- Acronym / sponsor ID
- IRB NO 00010556-IORG 0008839
- Conditions
- Fracture of Condylar Process
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 15 Sep 2021 (estimated)
- First posted
- 27 Apr 2021 (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 a common mandibular fracture which accounts for 25-40%. Nowadays the preference started to change towards open reduction because of the late complications that might happen in case of closed treatment.
A Transmasseteric Anteroparotid (TMAP) approach for open reduction and internal fixation of condylar fractures overcomes the problems of difficult access and facial nerve injury risk of other conventional approaches.
Different plating options are available for internal fixation of the condyle and subcondylar region. Trapezoidal Condylar Plates (TCP) specifically developed for the osteosynthesis of low and high subcondylar fracture. These plates were designed to closely follow the tensile strain lines along the rim of the sigmoid notch anteriorly combined with a posterior arm to parallel the condylar axis free of harmful bending strains.
Detailed description
Background: Condylar fracture is a common mandibular fracture which accounts for 25-40%. It is the most controversial fractures regarding diagnosis and management.
For several years, closed reduction has been preferred over open reduction to avoid surgical complications. Nowadays the preference started to change towards open reduction because of the late complications that might happen in case of closed treatment.
A Transmasseteric Anteroparotid (TMAP) approach for open reduction and internal fixation of condylar fractures overcomes the problems of difficult access and facial nerve injury risk of other conventional approaches.
Different plating options are available for internal fixation of the condyle and subcondylar region. Trapezoidal Condylar Plates (TCP) specifically developed for the osteosynthesis of low and high subcondylar fracture. These plates were designed to closely follow the tensile strain lines along the rim of the sigmoid notch anteriorly combined with a posterior arm to parallel the condylar axis free of harmful bending strains.
Aim: Our aim in this study is to assess the use of TCP in the subcondylar fracture in comparison to the use of conventional two miniplates method.
Materials and methods: This prospective randomized clinical trial will enroll 20 patients with subcondylar fracture indicated for open reduction and internal fixation. Group A will undergo fixation with TCP and group B will have two miniplates fixation. Both groups will have Transmasseteric Anteroparotid approach.
Results: The results of the two groups will be compared clinically and radiographically.
Keywords: Subcondylar fracture, Trapezoidal condylar plate, two miniplates, open treatment for condyle, geometric subcondylar plates, transmasseteric anteroparotid approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trapezoidal condylar plate | Active comparator | Device: trapezoidal condylar plateTrapezoidal condylar plate open reduction and internal fixation of subcondylar fractures |
| two miniplates | Active comparator | Device: two miniplatestwo miniplates open reduction and internal fixation of subcondylar fractures |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 1- Medically fit patients free from relevant conditions that contraindicate surgery.
- 2- Patients with age ranged from 20-40 years old. 3- 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
Key exclusion criteria (2 listed)
- 1. Patients who were not able to follow the information given or to make a decision themselves due to mental or other problems.
- 2. Any absolute contraindication for surgery. 3. 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 |
|---|---|---|
| trapezoidal condylar platetrapezoidal condylar plate open reduction and fixation | Device | Trapezoidal condylar plate |
| two miniplatestwo miniplates open reduction and fixation | Device | two miniplates |
Primary outcome
comparison of functional mandibular movement between the two groups
Time frame: preopertive, 1 week, 1month , 3 months , 6months
the change mandibular movement in mm
comparison of occlusion between the two groups
Time frame: preopertive, 1 week, 1month , 3 months , 6months
the change in occlusion intercuspation assessed visually by the surgeon and by asking the patient
comparison of helikmo index between the two groups
Time frame: preopertive, 1 week, 1month , 3 months , 6months
the change in helikmo index score
comparison in pain between the two groups
Time frame: preopertive, 1 week, 1month
the change in pain value with Visual analogue Scale With a visual analogue scale (VAS) with values from 0 (no pain) to 10 (strongest pain or discomfort)
comparison in ramus height shortening between the two groups
Time frame: 1 day, 3 months, 6 months.
radiographically: assess the adequacy of reduction by th change in ramus height in mm
comparison in condylar angulation between the two groups
Time frame: 1 day, 3 months, 6 months.
radiographically: assess the adequacy of reduction by measuring the change in condylar angulation
bone density change comparison between the two groups
Time frame: 1 day postoperative, 1month and 3months
assessment with CT in Hounsfield value measurements.
3 secondary outcomes
Transmasseteric Anteroparotid surgical approach
Time frame: intraopertive
the stress on plates by using finite element analysis
Time frame: immediate postopertive
the displacement (micromotion)
Time frame: immediate postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- Individual participant dataSharing planned: No
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.
nagy el prince, professor study chair
oral and maxillofacial surgery, alexanderia university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing trapezoidal condylar plate and two miniplates in people with Fracture of Condylar Process, 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 2 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 22 Jul 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mona oraby, ass. lect. (00201000775330, drmonasamy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of functional mandibular movement between the two groups (time frame: preopertive, 1 week, 1month , 3 months , 6months). The study lists 7 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 22 Jul 2021.