Mandibular Fractures
Conditions
Keywords
Angle fracture, superior-inferior plate fixation, custom made plate fixation, postoperative complications
Brief 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.
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 .
Interventions
PROCEDURECustomized 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 .
PROCEDUREConventional miniplates fixation
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.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Because the two interventions used in this trial are easily recognized by the participants and the investigator, neither the investigator nor the participant can be blinded. But, assessor and the statistician will be blinded.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mouth Opening | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occlusion | immediate postoperative day | Occlusion will be evaluated by intraoral examination and write in dental chart whether normal or abnormal occlusion |
Countries
Egypt
Contacts
Primary ContactHiba O Saleh, Phd.student
Outcome results
None listed