Clinical trial NCT03761524: Evaluation of Customized V Plate Versus Conventional Miniplates of Mandibular Angle Fracture
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mandibular Fractures
Keywords: Angle fracture
superior-inferior plate fixation
custom made plate fixation
postoperative complications
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-12-03
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

Eligibility criteria: 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).

Primary outcomes:
measure: Mouth Opening
timeFrame: Every week for 1 month ,3 months and 6 months postoperative
measure: Radiographical parameters
timeFrame: At 3 and 6 months postoperatively
Secondary outcomes:
measure: Occlusion
timeFrame: immediate postoperative day
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry-Cairo University
Study officials:
affiliation: Cairo University
name: Hiba O Saleh, Phd.student
role: PRINCIPAL_INVESTIGATOR
References: