An interventional study of ORIF using Pin Buckle bone plate and ORIF using conventional two miniplates in Posterior Mandibular Fractures Involving the Body or Angle Region, sponsored by Suez Canal University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Suez Canal University · Not applicable, Interventional, and Treatment
comparing new design of 3D titanium bone plate with less number of screws with conventional two miniplates in the treatment of posterior mandibular fractures involving the body or angle region
91 studies on the registry are indexed under Mandibular Fractures; 24 are open to participants now.
This study's enrollment of 20 is close to the median of 21 across 72 interventional studies indexed under Mandibular Fractures.
Browse Mandibular Fractures studies →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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ten patients with posterior mandibular fractures involving the body or angle region, were treated with pin buckle bone plate
Procedure: ORIF using Pin Buckle bone plate
ten patients with posterior mandibular fractures involving the body or angle region, were treated with conventional two miniplates
Procedure: ORIF using conventional two miniplates
open reduction and internal fixation
Open Reduction and Internal Fixation
Change in Radiographic Fracture-Line Width
The width of the fracture line will be measured in millimeters using DIGORA image analysis software on standardized digital panoramic radiographs. Measurements will be performed at three standardized points (superior, middle, and inferior) along the visible fracture line, and the mean value will be calculated. Changes from baseline will be assessed at 3 and 6 months postoperatively and compared between the study and control groups.
Time frame: Immediately postoperatively (baseline), 3 months, and 6 months postoperatively.
Change in Radiographic Bone Density at the Fracture Site
Radiographic bone healing will be assessed by measuring the mean grayscale value at the fracture site using DIGORA image analysis software on standardized digital panoramic radiographs. Measurements will be performed using a standardized region of interest (ROI) at the immediate postoperative baseline, 3 months, and 6 months postoperatively. The change in mean grayscale values from baseline to 3 and 6 months will be evaluated and compared between the study and control groups.
Time frame: Immediately postoperatively (baseline), 3 months, and 6 months postoperatively.
Postoperative Pain Intensity
Postoperative pain intensity will be evaluated using a 10-cm Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst pain imaginable). Patients will be asked to indicate their pain intensity at each follow-up assessment. Pain scores will be compared between the study and control groups.
Time frame: Postoperative days 1, 7, and 14.
Postoperative Facial Edema
Facial edema will be assessed using standardized tape measurements between two anatomical landmarks: the tragus and corner of the mouth, and the lateral canthus and gonion. The sum of the two measurements will be calculated. Changes in the summed measurements relative to the preoperative baseline will be used to evaluate postoperative facial edema and compared between the study and control groups.
Time frame: Preoperatively (baseline) and postoperative days 1, 7, and 14.
Postoperative Wound Healing
Wound healing will be evaluated clinically using a structured scoring system consisting of five parameters: wound size reduction, tissue appearance, wound exudate, pain and inflammatory response, and mucosal integrity. Each parameter will be scored from 0 (poor) to 2 (good), resulting in a total score ranging from 0 to 10, with higher scores indicating better wound healing. Total wound healing scores will be compared between the study and control groups.
Time frame: Postoperative days 1, 7, and 14.
Clinical Stability of Fracture Segments
Fracture stability will be assessed by bimanual digital palpation to detect mobility between fracture segments during functional mandibular movements and manual manipulation. Fractures will be classified as stable (absence of detectable movement) or unstable (presence of detectable movement). The proportion of stable fractures will be compared between the study and control groups.
Time frame: Immediately postoperatively and 6 months postoperatively.
Plan to share: No
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Ran from Jul 2025 to primary completion in Mar 2026, 7 months.
Of 38 non-industry interventional studies with no phase under Mandibular Fractures, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 24. This study's 7 months is below that.
Counting every sponsor, half of 38 studies reached it within 13 months; a quarter within 9 and three quarters within 24.
How these figures are worked out, and which studies are left out of them.
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 completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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