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Evaluation of Preauricular Retromandibular Anteroparotid Versus Retromandibular Through Parotid Approach

Primary Purpose

Subcondylar Process of Mandible Open Fracture, Facial Nerve Injuries

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
PRA approach
RT approach
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Subcondylar Process of Mandible Open Fracture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Faculty of dental and oral medicine / Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PRA approach

RT approach

Arm Description

PRA extends downward in curvilinear fashion in cervicomastoid skin crease

RT begins 5mm below the ear lobe and continues 3 to 3.5cm inferiorly.

Outcomes

Primary Outcome Measures

Minimize facial nerve injury
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
Regarding salivary fistula the measuring device is clinical examination while the measuring unit is binary question.

Secondary Outcome Measures

Reduce scar formation
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

Full Information

First Posted
December 24, 2018
Last Updated
July 29, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03803150
Brief Title
Evaluation of Preauricular Retromandibular Anteroparotid Versus Retromandibular Through Parotid Approach
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
January 30, 2022 (Actual)
Study Completion Date
May 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subcondylar Process of Mandible Open Fracture, Facial Nerve Injuries

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Block, consecutive, 1:1 Consecutive because patients with subcondylar fracture need immediate surgical intervention, that is why investigators can not wait to collect the whole sample size and make computer generated randomization .
Masking
None (Open Label)
Masking Description
Senior supervisor Prof. Dr. Hairy El mossy will generate the allocation sequence.
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRA approach
Arm Type
Experimental
Arm Description
PRA extends downward in curvilinear fashion in cervicomastoid skin crease
Arm Title
RT approach
Arm Type
Active Comparator
Arm Description
RT begins 5mm below the ear lobe and continues 3 to 3.5cm inferiorly.
Intervention Type
Procedure
Intervention Name(s)
PRA approach
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
RT approach
Intervention Description
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.
Primary Outcome Measure Information:
Title
Minimize facial nerve injury
Description
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
Time Frame
Concerning the facial injury will be at 6 months
Title
Minimize salivary fistula
Description
Regarding salivary fistula the measuring device is clinical examination while the measuring unit is binary question.
Time Frame
Salivary fistula at 1 week
Secondary Outcome Measure Information:
Title
Reduce scar formation
Description
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
Time Frame
at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients age should be more than 18 year. Patients with subcondylar fracture and need to open reduction and internal fixation using titanium miniplates. Patients should be free from any traumatic injuries to facial nerve or parotid gland. Availability of preoperative and postoperative panoramic radiographs and/or computed tomography (CT) images. Mental status permitting an adequate neuromotor examination. 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: Intraoral treatment of subcondylar fracture. Incooperative patients.
Facility Information:
Facility Name
Faculty of dental and oral medicine / Cairo University
City
Cairo
ZIP/Postal Code
12816
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Once I finished the study I will share the data
Citations:
PubMed Identifier
19231779
Citation
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Results Reference
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Citation
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Citation
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Citation
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Results Reference
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PubMed Identifier
15620776
Citation
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Citation
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Evaluation of Preauricular Retromandibular Anteroparotid Versus Retromandibular Through Parotid Approach

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