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UnknownNCT03761524

Evaluation of Customized V Plate Versus Conventional Miniplates of Mandibular Angle Fracture

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
24 (estimated)
Sponsor
Cairo University · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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 .

Conditions

Interventions

TypeNameDescription
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 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.

Timeline

Start date
2019-08-01
Primary completion
2021-08-01
Completion
2021-09-01
First posted
2018-12-03
Last updated
2019-07-29

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT03761524. Inclusion in this directory is not an endorsement.