Facial Nerve InjuriesNCT07807813
Safety-zone Approach and Facial Nerve Preservation in Transbuccal-accessed Fixation of Mandibular Fractures
A study testing Landmarking Safety-zone in people with Facial Nerve Injuries and Mandibular Fractures, run by Delta University for Science and Technology at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Facial Nerve Injuries, Mandibular Fractures, Surgical Incision
- What is being tested?
- Landmarking Safety-zone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Sep 2026to Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Department of Oral and Maxillofacial Surgery, Faculty of Oral and Dental Medicine, Delta University for Science and Technology
Al Mansurah, Addakahlyia, 35516
Mohammad Abdelhamid, PhD, 00201002285659, hamidsurgeon@gmail.com
About this study
Official title: Validity of Safety-zone Approach on Facial Nerve Preservation During Transbuccal-accessed Fixation of Mandibular Fractures
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.
Read the 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.
- Being tested
- Landmarking Safety-zone
- Keywords
- Facial Nerve Injuries, Mandibular Fractures, Mandibular Angle Fractures, Iatrogenic Injury, Surgical Incision
- Medical subject headings
- Facial Nerve Injuries, Mandibular Fractures, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Landmarking Safety-zoneProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Landmarking Safety-zone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: First postoperative week, and third postoperative week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start5 Sep 2026
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial Nerve InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Delta University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammad Abdelhamid, PhD, Principal investigator, Department of Oral and Maxillofacial Surgery, Faculty of Oral and Dental Medicine, Delta University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07807813
- Sponsor's protocol ID
- DU:0240521007
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No