CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
PRA approach +1 moreprocedure
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03803150
NCT03803150N/ACompleted

A Comparative Study Between Preauricular Retromandibular Anteroparotid Approach and Retromandibular Transparotid Approach in Internal Fixation of Subcondylar Fracture on Facial Nerve Injury and Parotid Fistula

Cairo University·interventional·Posted Jan 14, 2019·Updated Aug 2, 2022

In Brief

A clinical study evaluating PRA approach and RT approach for Subcondylar Process of Mandible Open Fracture and Facial Nerve Injuries. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesEgypt
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJan 14, 2019
Enrollment StartFeb 1, 2019
Primary CompletionJan 30, 2022
Study CompletionMay 8, 2022
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 7.5 years ago

Interventions

PRA approachprocedure

A preauricular incision will be made that extends downwards in a curvilinear fashion in the cervicomastoid skin crease, though any variation in this incision will suffice. The great auricular nerve will be preserved and the flap raised in the subdermal fat plane, superficial to the superficial musculoaponeurotic layer to allow access to the masseter adjacent to the anteroinferior edge of the parotid gland, just below the parotid duct. Branches of the facial nerve will be readily identified and avoided with or without loupe magnification, on the surface of the masseter muscle.

RT approachprocedure

The incision for the retromandibular approach begins 5mm below ear lobe and continues 3 to 3.5cm inferiorly. Initial incision begins through skin and subcutaneous tissues,platysma muscle ,(SMAS), parotid capsule Dissection is continued until the only tissue remaining on the posterior border of the mandible will be the periosteum of pterygomassetric sling,then the fracture site will exposed and reduced.