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Safety-zone Approach and Facial Nerve Preservation in Transbuccal-accessed Fixation of Mandibular Fractures

Validity of Safety-zone Approach on Facial Nerve Preservation During Transbuccal-accessed Fixation of Mandibular Fractures

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07807813
Enrollment
16
Registered
2026-09-08
Start date
2026-09-05
Completion date
2026-12-01
Last updated
2026-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Facial Nerve Injuries, Mandibular Fractures, Surgical Incision

Keywords

Facial Nerve Injuries, Mandibular Fractures, Mandibular Angle Fractures, Iatrogenic Injury, Surgical Incision

Brief summary

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.

Detailed description

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.

Interventions

PROCEDURELandmarking 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.

Sponsors

Delta University for Science and Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Facial Nerve Affection Using Sunnybrook Facial Grading System (in numbers from 0 to 100)First postoperative week, and third postoperative week.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

Countries

Egypt

Contacts

CONTACTMohammad Abdelhamid, PhD
hamidsurgeon@gmail.com00201002285659
PRINCIPAL_INVESTIGATORMohammad Abdelhamid, PhD

Department of Oral and Maxillofacial Surgery, Faculty of Oral and Dental Medicine, Delta University for Science and Technology

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026