Safety-zone for cheek-access mandibular fracture fixation to protect facial nerve

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study investigates a landmarked safety-zone triangle to guide cheek incisions during transbuccal access for open reduction and internal fixation of mandibular fractures. The approach combines transoral fracture reduction with transbuccal drilling and plating, using a small extraoral cheek incision. The trial assesses whether following these predefined landmarks reduces postoperative facial nerve injury compared with standard techniques. Eligible participants have non-comminuted mandibular fractures requiring miniplate fixation and meet general anesthesia fitness criteria. Exclusion criteria include neurological disorders, recent nerve-supporting supplements, facial lacerations, and infected fractures.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Healthy patients (American Society of Anesthesiologists Class I)
* Patients with mandibular fracture that require open reduction and internal fixation with miniplates and screws.
* Mandibular fractures that couldn't be accessed transorally only.
* Non-comminuted fractures

Exclusion Criteria:

* Patients with neurological disorders.
* Patients who take nerve-supporting supplements (such as Vitamin B12 or Vitamin B complex) prior to surgery.
* Presence of facial laceration.
* Infected fractures

Where it's running

• Department of Oral and Maxillofacial Surgery, Faculty of Oral and Dental Medicine, Delta University for Science and Technology
  Al Mansurah, Addakahlyia, Egypt Recruiting

Study contacts

• Principal investigator: Mohammad Abdelhamid, PhD — Department of Oral and Maxillofacial Surgery, Faculty of Oral and Dental Medicine, Delta University for Science and Technology
• Study coordinator: Mohammad Abdelhamid, PhD
• Email: hamidsurgeon@gmail.com
• Phone: 00201002285659

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.