Mandibular FracturesNCT03761524
Evaluation of Customized V Plate Versus Conventional Miniplates of Mandibular Angle Fracture
A study testing Customized V plate fixation and Conventional miniplates fixation in people with Mandibular Fractures, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of the study to evaluate the effect of customized V pattern plate fixation versus a conventional superior-inferior mini plates fixation of mandibular angle fracture on mouth opening and radio graphical parameters. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mandibular Fractures
- What is being tested?
- Customized V plate fixation and Conventional miniplates fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2019to 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with at least a unilateral unfavorable angle fracture indicated for Open reduction internal fixation alone or in combination with fracture elsewhere in the mandible or midrace.
- Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome
Who cannot join
- Patients with systemic disease (may affect normal healing).
- Patients with old and/or malunited fractures (affect accuracy of reduction of the fractured segments).
- Patients whom cannot tolerate follow up intervals (affect accuracy of study results).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Customized V Plate Fixation Versus a Conventional Superior -Inferior Miniplates Fixation of Mandibular Angle Fracture on Mouth Opening and Radiographical Parameters Randomized Clinical Trial
The aim of the study to evaluate the effect of customized V pattern plate fixation versus a conventional superior-inferior mini plates fixation of mandibular angle fracture on mouth opening and radio graphical parameters.
Read the detailed description
The mandibular angle is one of the most common sites for fractures, accounting for 23-42% of all cases of mandibular fractures. Moreover, mandibular angle fractures have the highest postoperative complications among all mandibular fractures, and the loosening of screws and fracturing of plates are main reasons for the complications.The most widely used treatment modality for mandibular angle fracture is the use of one miniplate fixation ,The other one uses two mini-plates, with a upper mini-plate fixed at the same place of previous treatment which corresponds to the tension band of the mandible, and the lower mini-plate fixed at the inferior border of the mandible which corresponds to the compression band of the mandible, however, based on recent experimental and clinical studies, the stability provided by the miniplate fixation of mandibular angle fractures has become a point of contention among surgeons .In order to decrease the need for plate removal, reduce the operative time and improve the stability of the fixation system, a customized V pattern plate design is an appropriate plate structure for fractured mandible using the minimum output values for stress of plate and displacement of bony segments to seek maximum reduction volume on an original plate .Patient satisfaction include: clinical parameters such are occlusion, pain, facial swelling, maximal mouth opening, sensory function, and surgical wound ,these should be evaluated postoperatively ,radio graphical evaluation is also an important parameter to assess adequate reduction of the fractured segments .
- Conditions
- Mandibular Fractures
- Being tested
- Customized V plate fixation, Conventional miniplates fixation
- Keywords
- Angle fracture, superior-inferior plate fixation, custom made plate fixation, postoperative complications
- Medical subject headings
- Mandibular Fractures, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Customized V plate fixationProcedure or surgery
(CT) scan is taken for the patients and a customized V pattern plate will be designed .Intraoral approach will be done to expose the angle fracture.Fracture site will be exposed and reduced in normal anatomic position guided by the CAD/CAM plate. MMF will be done.Fracture fragments will be fixed using CAD/CAM plate .
Conventional miniplates fixationProcedure or surgery
Intraoral approach will be done to expose the angle fracture.Fracture site will be exposed and reduced in normal anatomic position. MMF will be done.Fracture fragments will be fixed using conventional miniplates fixation of angle fracture.
| Study group | Role | What they receive |
|---|---|---|
| Customized V plate fixation | Experimental | Computed tomography (CT) scan of the Facial bones (Axial cuts, DICOM file, Gantry tilt zero and minimal thickness of 1mm )is taken for the patients and a customized V pattern plate Receives: Procedure: Customized V plate fixation |
| Conventional miniplates fixation | Active comparator | Conventional superior-inferior miniplates fixation of mandibular angle fixation Receives: Procedure: Conventional miniplates fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mouth Opening
Mouth Opening is evaluated by measurement of maximal interincisal opening between maxilaary and mandibular central incisiors by the caliper and measuring unit is mm
Measured: Every week for 1 month ,3 months and 6 months postoperative
Radiographical parameters
Radiographical parameters (Bone Density) is detected through CT scan to evaluate bone density in Hounsfield unit in the area of plate fixation to determine the effect of the plate stress over the fracture site Measures format will be summarized as mean
Measured: At 3 and 6 months postoperatively
Secondary outcomes (1)
Occlusion
Occlusion will be evaluated by intraoral examination and write in dental chart whether normal or abnormal occlusion
Measured: immediate postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study startAug 2019 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mandibular FracturesStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hiba Obad Saleh Saeed, Cairo University
- Investigators
- Hiba O Saleh, Phd.student, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03761524
- Sponsor's protocol ID
- 543
- Status last verified
- Jul 2019
- First submitted
- 29 Nov 2018
- Last updated
- 29 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saleh HO, Moussa BG, Salah Eddin KA, Noman SA, Salah AM. Assessment of CAD/CAM Customized V Pattern Plate Versus Standard Miniplates Fixation in Mandibular Angle Fracture (Randomized Clinical Trial). J Maxillofac Oral Surg. 2023 Dec;22(4):995-1005. doi: 10.1007/s12663-023-02027-x. Epub 2023 Oct 27.
PubMed 38105847
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Customized V Plate Fixation Versus a Conventional Superior -Inferior Miniplates Fixation of Mandibular Angle Fracture on Mouth Opening and Radiographical Parameters Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03761524
- Acronym / sponsor ID
- 543
- Conditions
- Mandibular Fractures
- Keywords
- Angle fracture, superior-inferior plate fixation, custom made plate fixation, postoperative complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Aug 2019 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 3 Dec 2018 (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 aim of the study to evaluate the effect of customized V pattern plate fixation versus a conventional superior-inferior mini plates fixation of mandibular angle fracture on mouth opening and radio graphical parameters.
Detailed description
The mandibular angle is one of the most common sites for fractures, accounting for 23-42% of all cases of mandibular fractures. Moreover, mandibular angle fractures have the highest postoperative complications among all mandibular fractures, and the loosening of screws and fracturing of plates are main reasons for the complications.The most widely used treatment modality for mandibular angle fracture is the use of one miniplate fixation ,The other one uses two mini-plates, with a upper mini-plate fixed at the same place of previous treatment which corresponds to the tension band of the mandible, and the lower mini-plate fixed at the inferior border of the mandible which corresponds to the compression band of the mandible, however, based on recent experimental and clinical studies, the stability provided by the miniplate fixation of mandibular angle fractures has become a point of contention among surgeons .In order to decrease the need for plate removal, reduce the operative time and improve the stability of the fixation system, a customized V pattern plate design is an appropriate plate structure for fractured mandible using the minimum output values for stress of plate and displacement of bony segments to seek maximum reduction volume on an original plate .Patient satisfaction include: clinical parameters such are occlusion, pain, facial swelling, maximal mouth opening, sensory function, and surgical wound ,these should be evaluated postoperatively ,radio graphical evaluation is also an important parameter to assess adequate reduction of the fractured segments .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Customized V plate fixation | Experimental | Procedure: Customized V plate fixationComputed tomography (CT) scan of the Facial bones (Axial cuts, DICOM file, Gantry tilt zero and minimal thickness of 1mm )is taken for the patients and a customized V pattern plate |
| Conventional miniplates fixation | Active comparator | Procedure: Conventional miniplates fixationConventional superior-inferior miniplates fixation of mandibular angle fixation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with at least a unilateral unfavorable angle fracture indicated for Open reduction internal fixation alone or in combination with fracture elsewhere in the mandible or midrace.
- Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome
Key exclusion criteria (3 listed)
- Patients with systemic disease (may affect normal healing).
- Patients with old and/or malunited fractures (affect accuracy of reduction of the fractured segments).
- Patients whom cannot tolerate follow up intervals (affect accuracy of study results).
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 |
|---|---|---|
| Customized V plate fixation(CT) scan is taken for the patients and a customized V pattern plate will be designed .Intraoral approach will be done to expose the angle fracture.Fracture site will be exposed and reduced in normal anatomic position guided by the CAD/CAM plate. MMF will be done.Fracture fragments will be fixed using CAD/CAM plate . | Procedure or surgery | Customized V plate fixation |
| Conventional miniplates fixationIntraoral approach will be done to expose the angle fracture.Fracture site will be exposed and reduced in normal anatomic position. MMF will be done.Fracture fragments will be fixed using conventional miniplates fixation of angle fracture. | Procedure or surgery | Conventional miniplates fixation |
Primary outcome
Mouth Opening
Time frame: Every week for 1 month ,3 months and 6 months postoperative
Mouth Opening is evaluated by measurement of maximal interincisal opening between maxilaary and mandibular central incisiors by the caliper and measuring unit is mm
Radiographical parameters
Time frame: At 3 and 6 months postoperatively
Radiographical parameters (Bone Density) is detected through CT scan to evaluate bone density in Hounsfield unit in the area of plate fixation to determine the effect of the plate stress over the fracture site Measures format will be summarized as mean
1 secondary outcome
Occlusion
Time frame: immediate postoperative day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
- Derived from this study: PubMed 38105847Saleh HO, Moussa BG, Salah Eddin KA, Noman SA, Salah AM. Assessment of CAD/CAM Customized V Pattern Plate Versus Standard Miniplates Fixation in Mandibular Angle Fracture (Randomized Clinical Trial). J Maxillofac Oral Surg. 2023 Dec;22(4):995-1005. doi: 10.1007/s12663-023-02027-x. Epub 2023 Oct 27.
- 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.
Hiba O Saleh, Phd.student principal investigator
Cairo 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 Customized V plate fixation and Conventional miniplates fixation in people with Mandibular Fractures, run by Cairo 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 2 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: status not confirmed, as of the sponsor's last update on 29 Jul 2019. 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 Hiba O Saleh, Phd.student (00201010389391, dr.hiba2013@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mouth Opening (time frame: Every week for 1 month ,3 months and 6 months postoperative). 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?
On the ClinicalTrials.gov record for NCT03761524, which also lists 1 linked publication.
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 29 Jul 2019.