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

NCT07807813 | Recruiting

• 1 other identifier: DU:0240521007
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Facial Nerve Injuries; Mandibular Fractures; Surgical Incision

Keywords

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

Outcome Measures

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

  First postoperative week, and third postoperative week.

Study Arms (2)

Control Group (No Safety-Zone)

NO INTERVENTION

Patients with mandibular angle fractures undergoing open reduction and internal fixation (ORIF) will be approached transbuccally without landmarking extraoral safety-zone for cheek incision

Study Group (Safety-Zone)

ACTIVE COMPARATOR

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

Interventions

Landmarking Safety-zone PROCEDURE

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.

Study Group (Safety-Zone)

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Delta University for Science and Technology: lead

Study Sites (1)

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

Al Mansurah, Addakahlyia, 35516, Egypt

RECRUITING

MeSH Terms

Conditions

Facial Nerve Injuries; Mandibular Fractures; Surgical Wound

Condition Hierarchy (Ancestors)

Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Injuries; Cranial Nerve Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Skull Fractures; Fractures, Bone

Study Officials

• Mohammad Abdelhamid, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammad Abdelhamid, PhD

CONTACT

00201002285659; hamidsurgeon@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 8, 2026
• Study Start: September 5, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 9, 2026

Record last verified: 2026-09

Locations

EG (1)