Evaluation of Preauricular Retromandibular Anteroparotid Versus Retromandibular Through Parotid Approach

Not Applicable

Completed

• Conditions: Facial Nerve Injuries; Subcondylar Process of Mandible Open Fracture
• Interventions: Procedure: RT approach; Procedure: PRA approach

• Registration Number: NCT03803150
• Lead Sponsor: Cairo University

Brief Summary

Of all the bones in the maxillofacial area, the condylar process is the most susceptible to fracture. The incidence of condylar fracture accounts for 25% to 50% of all mandibular fractures. Though remained controversial for a long time, surgical treatment of displaced subcondylar fractures appears today as the gold standard.

Although there is a developing preference for open reduction and internal fixation of mandibular condylar fractures, the optimal approach to the ramus condylar unit remains controversial. Various approaches have been proposed, and each has specific shortcomings and disadvantages. Retromandibular, submandibular, transoral, and through parotid approaches are generally performed and sometimes used with an endoscope. Limited access and injury to the facial nerve are the most common problems, while Wilson introduced a new through masseter anteroparotid approach, this technique offers excellent access to the ramus condylar unit, and facial nerve damage risk is reduced.

Detailed Description

Fractures of the mandibular condylar process have been documented to be one of the most common occurring mandibular fractures.

When open treatment is selected, several surgical approaches can be used to expose, reduce, and stabilize the fracture site, each with its own set of advantages and disadvantages. Surgical approaches to the fractured mandibular condyle are broadly classified into intraoral and extraoral approaches. Intraoral approaches can be performed with or without endoscopic assistance. The most common extraoral approaches are submandibular, Risdon, preauricular, retroauricular, and retromandibular through parotid or through masseter approaches.

An intraoral approach is time consuming and requires special instruments such as an endoscope, and additional training. Furthermore, cases of high fractures and/or medially displaced condylar fractures are technically difficult to manage through an intraoral approach, incorrect anatomical reduction, condylar head resorption, myofascial pain, and malocclusions have been reported to be more common complications following the intraoral approach when compared to extraoral approaches.

In contrast, extraoral approaches are commonly used because they produce better visualization of the fracture site and therefore facilitate fracture reduction and fixation. However, extraoral approaches are complicated by the risk of injury to the facial, great auricular, and auriculotemporal nerves, visible scars, sialoceles, Frey syndrome and salivary fistulas.

Study Timeline

• Study First Submitted: 2018-12-24
• Study First Submitted QC: 2019-01-11
• Study First Posted: 2019-01-14
• Study Start: 2019-02-01
• Primary Completion: 2022-01-30
• Study Completion: 2022-05-08
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-29
• Last Update Posted: 2022-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Patients age should be more than 18 year.
2. Patients with subcondylar fracture and need to open reduction and internal fixation using titanium miniplates.
3. Patients should be free from any traumatic injuries to facial nerve or parotid gland.
4. Availability of preoperative and postoperative panoramic radiographs and/or computed tomography (CT) images.
5. Mental status permitting an adequate neuromotor examination.
6. Regular clinical follow-up, documented in our clinical and radiographic evaluation charts, at 1 week, 1 month, 3 months and 6 months postoperatively

Exclusion Criteria

1. Intraoral treatment of subcondylar fracture.
2. Incooperative patients.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RT approach	RT approach	RT begins 5mm below the ear lobe and continues 3 to 3.5cm inferiorly.
PRA approach	PRA approach	PRA extends downward in curvilinear fashion in cervicomastoid skin crease

Primary Outcome Measures

Name	Time	Method
Minimize facial nerve injury	Concerning the facial injury will be at 6 months	Regarding facial nerve injury the measuring device is House- brachmann facial nerve grading system (HBFNGS) while the measuring unit is numerical from (I-VI) I= Normal, II= Mild dysfunction, III= Moderate dysfunction, IV= Moderately severe dysfunction, V= Severe dysfunction, VI= Total paralysis.; I= Better while VI= Worse
Minimize salivary fistula	Salivary fistula at 1 week	Regarding salivary fistula the measuring device is clinical examination while the measuring unit is binary question.

Secondary Outcome Measures

Name	Time	Method
Reduce scar formation	at 6 months	The character of any observed scar was scored as (1) no perceptible scar, (2) visible but thin and linear scar, (3) wide scar, and (4) hypertrophic scar or keloid. while the measuring unit is numerical from (1-4); 1= Better while 4= Worse

Trial Locations

Locations (1)

Faculty of dental and oral medicine / Cairo University; 🇪🇬 Cairo, Egypt