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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-45
SponsorDelta University for Science and Technology

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Landmarking Safety-zone

    Procedure/Surgery

    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.

Treatment groups

16 Participants
are divided into 2 treatment groups
Group A: Control Group (No Safety-Zone)No intervention 0 interventions
Group B: Study Group (Safety-Zone)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Secondary outcomes

Other outcomes

Sponsors and contacts

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