An interventional study of Landmarking Safety-zone in Facial Nerve Injuries, Mandibular Fractures and Surgical Incision, sponsored by Delta University for Science and Technology. Recruiting at 1 site in Egypt. Open to participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Delta University for Science and Technology · Not applicable, Interventional, and Prevention
The goal of this study is to investigate the efficacy of a safety-zone that is anatomically landmarked on the face of patients with mandibular fractures that are approached transbuccally (through cheek) on postoperative intactness of facial nerve.
Mandibular fractures, in particular mandibular angle fractures, can be fixed with various techniques. Of all, open reduction and internal fixation (with titanium plates and screws) stands as one of the most commonly used techniques for mandibular angle fracture management.
Different approaches could be followed to access the mandibular angle. Transbuccal approach is considered one of the most conservative approaches for such goal. Conjoined with a transoral access for fracture reduction and plates adaptation, a small incision is made extraorally on the cheek opposite to the fracture line to facilitate application of a transbuccal trocar, through which drilling and screws fixation can be done into the plates.
A reported risk of facial nerve injury raises fears towards this extraoral cheek incision, even being considerably small. That's why a safety-zone was proposed as a triangle between three lines drawn cross each other. The first is drawn from the ear tragus to the facial notch. The second is drawn from the outer eye canthus to the mandibular angle. The third is on the lower mandibular border. This safety-zone triangle was suggested beforehand in a cadeveric study to be a safe land for cheek incisions without endangering the facial nerve branches, in particular buccal and marginal mandibular branches.
This study aims at testing whether the implementation of this safety-zone may decrease the risk of facial nerve affection among patients in whom these landmarks were followed, or there may not be such difference between these patients and other patients who underwent same fracture pattern management with the same approach but without implementing these safety-zone landmarks.
91 studies on the registry are indexed under Mandibular Fractures; 24 are open to participants now.
This study's planned enrollment of 16 is below the median of 21 across 72 interventional studies indexed under Mandibular Fractures.
Browse Mandibular Fractures studies →Delta University for Science and Technology is the lead sponsor of 86 studies on the registry; 16 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.
Patients with mandibular angle fractures undergoing open reduction and internal fixation (ORIF) will be approached transbuccally without landmarking extraoral safety-zone for cheek incision
Patients with mandibular angle fractures undergoing open reduction and internal fixation (ORIF) will be approached transbuccally after landmarking extraoral safety-zone for cheek incision
Procedure: Landmarking Safety-zone
A safety-zone triangle for transbuccal incision is encased between three lines: the first is a line drawn from the ear tragus to the facial notch. The second is drawn from the outer eye canthus to the mandibular angle. The third is on the lower mandibular border.
Postoperative Facial Nerve Affection Using Sunnybrook Facial Grading System (in numbers from 0 to 100)
Facial nerve function is tested after surgery through subjective facial expressions by the patient and judged by two different investigators grading them on Sunnybrook Facial Grading System
Time frame: First postoperative week, and third postoperative week.
Started Sep 2026 (actual). Primary completion is estimated for Nov 2026, 2 months after the start.
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 planned 2 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.
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Delta University for Science and Technology