An interventional study of open reduction and fixation of the fracture and open reduction and fixation of body and angle mandible fracture in Mandibular Angle Fractures and Mandibular Body Fractures, sponsored by Suez Canal University. Not yet recruiting. Open to participants aged 21 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Suez Canal University · Not applicable, Interventional, and Treatment
Clinical and Radiographic Assessment of H-shaped Bone Plates in Management of Body and Angle Mandibular Fractures
Various miniplate systems have been developed in recent years including three-dimensional miniplate, microplates and bioresorbable plates, their advantages and disadvantages have been extensively compared and studied. To overcome the shortcomings of 3D plating system such as difficulty in adaptation and fixation in fractures involving the mental nerve, a novel Hplate has been designed. Aim: to evaluate H-shaped bone plates in mandibular fracture management clinically and radiographically.
Suez Canal University is the lead sponsor of 164 studies on the registry; 38 are open to participants now.
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Exclusion Criteria:
Patients with body or angle mandibular fracture will receive H shape plate for fixation
Procedure: open reduction and fixation of the fracture
paitents with body or angle mandiblar fracture will recive conventional plates for fixation
Procedure: open reduction and fixation of body and angle mandible fracture
the use of H shape plate in fixation of body and angle mandibular fracture
the use of conventional plate in fixation of body and angle mandibular fracture
Postoperative Pain Intensity as Assessed by a Visual Analogue Scale (VAS) at 1 and 7 Days Postoperatively
The Visual Analogue Scale (VAS) consists of a 10-centimeter (cm) line, with two endpoints representing a minimum value of 0 ("no pain") and a maximum value of 10 ("pain as bad as it could possibly be"). Patients rate their current level of pain by placing a mark on the line. Higher scores indicate a worse outcome (increased pain intensity).
Time frame: one to seven days after operation
Postoperative Facial Edema as Measured by the Tape Measuring Test at 1 and 7 Days Postoperatively
Facial swelling is quantified using a flexible tape measure while the patient is seated upright with teeth in occlusion. Measurements are recorded in centimeters (cm) as the sum of two lines connecting four predetermined facial reference points: ear tragus to the corner of the mouth, and gonion to the external canthus of the eye. Changes occurring between the follow-up intervals and baseline will be reported. An increase in the sum of these measurements indicates a worse outcome (increased swelling).
Time frame: one to seven days after operation
Proportion of Participants with Stable Fracture Segments as Assessed by Bimanual Digital Manipulation at 1 and 7 Days Postoperatively
Bimanual digital manipulation is performed clinically by the investigator to evaluate the mobility of the bone fracture segments. Fracture segment stability is recorded as a categorical outcome: 1) "Stable" (indicating no movement of fragments, representing a successful/better outcome) or 2) "Nonstable" (indicating the presence of movement, representing a worse outcome).
Time frame: one to seven days
Change from Baseline in Radiographic Bone Density at the Fracture Line at 1 and 4 Months Postoperatively
Panoramic radiographs are performed using a digital panoramic machine to evaluate progressive bone healing. Bone density is quantified by measuring the radiographic gray-scale values at the site of the plate over the fracture line using OnDemand software. An increase in gray-scale value over time relative to the immediate postoperative baseline indicates progressive bone healing and successful bone union, representing a better outcome.
Time frame: Immediate postoperatively (baseline), 1 month, and 4 months postoperative
No study locations are listed for this record.
Plan to share: Yes
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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