Evaluation of Preauricular Retromandibular Anteroparotid Versus Retromandibular Through Parotid Approach

NCT03803150 | Completed DMC

• 1 other identifier: TMAP in subcondylar fracture
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Subcondylar Process of Mandible Open Fracture; Facial Nerve Injuries

Outcome Measures

Primary Outcomes (2)

• 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

  Concerning the facial injury will be at 6 months

• Minimize salivary fistula

  Regarding salivary fistula the measuring device is clinical examination while the measuring unit is binary question.

  Salivary fistula at 1 week

Secondary Outcomes (1)

• Reduce scar formation

  at 6 months

Study Arms (2)

PRA approach

EXPERIMENTAL

PRA extends downward in curvilinear fashion in cervicomastoid skin crease

Procedure: PRA approach

RT approach

ACTIVE COMPARATOR

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

Procedure: RT approach

Interventions

PRA approach PROCEDURE

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.

PRA approach

RT approach PROCEDURE

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.

RT approach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Intraoral treatment of subcondylar fracture.
• Incooperative patients.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of dental and oral medicine / Cairo University

Cairo, 12816, Egypt

Location

Related Publications (13)

• Tang W, Gao C, Long J, Lin Y, Wang H, Liu L, Tian W. Application of modified retromandibular approach indirectly from the anterior edge of the parotid gland in the surgical treatment of condylar fracture. J Oral Maxillofac Surg. 2009 Mar;67(3):552-8. doi: 10.1016/j.joms.2008.06.066.

  PMID: 19231779 RESULT

• Lutz JC, Clavert P, Wolfram-Gabel R, Wilk A, Kahn JL. Is the high submandibular transmasseteric approach to the mandibular condyle safe for the inferior buccal branch? Surg Radiol Anat. 2010 Dec;32(10):963-9. doi: 10.1007/s00276-010-0663-z. Epub 2010 May 12.

  PMID: 20461515 RESULT

• Guerrissi JO. A transparotid transcutaneous approach for internal rigid fixation in condylar fractures. J Craniofac Surg. 2002 Jul;13(4):568-71. doi: 10.1097/00001665-200207000-00018.

  PMID: 12140424 RESULT

• Ozkan HS, Sahin B, Gorgu M, Melikoglu C. Results of transmasseteric anteroparotid approach for mandibular condylar fractures. J Craniofac Surg. 2010 Nov;21(6):1882-3. doi: 10.1097/SCS.0b013e3181f4aef7.

  PMID: 21119445 RESULT

• Wilson AW, Ethunandan M, Brennan PA. Transmasseteric antero-parotid approach for open reduction and internal fixation of condylar fractures. Br J Oral Maxillofac Surg. 2005 Feb;43(1):57-60. doi: 10.1016/j.bjoms.2004.09.011.

  PMID: 15620776 RESULT

• Zachariades N, Papavassiliou D. The pattern and aetiology of maxillofacial injuries in Greece. A retrospective study of 25 years and a comparison with other countries. J Craniomaxillofac Surg. 1990 Aug;18(6):251-4. doi: 10.1016/s1010-5182(05)80425-1.

  PMID: 2212022 RESULT

• Villarreal PM, Monje F, Junquera LM, Mateo J, Morillo AJ, Gonzalez C. Mandibular condyle fractures: determinants of treatment and outcome. J Oral Maxillofac Surg. 2004 Feb;62(2):155-63. doi: 10.1016/j.joms.2003.08.010.

  PMID: 14762747 RESULT

• Choi BH, Yoo JH. Open reduction of condylar neck fractures with exposure of the facial nerve. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1999 Sep;88(3):292-6. doi: 10.1016/s1079-2104(99)70030-2.

  PMID: 10503856 RESULT

• Salgarelli AC, Anesi A, Bellini P, Pollastri G, Tanza D, Barberini S, Chiarini L. How to improve retromandibular transmasseteric anteroparotid approach for mandibular condylar fractures: our clinical experience. Int J Oral Maxillofac Surg. 2013 Apr;42(4):464-9. doi: 10.1016/j.ijom.2012.12.012. Epub 2013 Feb 8.

  PMID: 23395651 RESULT

• Jensen T, Jensen J, Norholt SE, Dahl M, Lenk-Hansen L, Svensson P. Open reduction and rigid internal fixation of mandibular condylar fractures by an intraoral approach: a long-term follow-up study of 15 patients. J Oral Maxillofac Surg. 2006 Dec;64(12):1771-9. doi: 10.1016/j.joms.2005.12.069.

  PMID: 17113444 RESULT

• Schmidseder R, Scheunemann H. Nerve injury in fractures of the condylar neck. J Maxillofac Surg. 1977 Sep;5(3):186-90. doi: 10.1016/s0301-0503(77)80103-3.

  PMID: 269890 RESULT

• Weinberg S, Kryshtalskyj B. Facial nerve function following temporomandibular joint surgery using the preauricular approach. J Oral Maxillofac Surg. 1992 Oct;50(10):1048-51. doi: 10.1016/0278-2391(92)90488-l.

  PMID: 1527657 RESULT

• Handschel J, Ruggeberg T, Depprich R, Schwarz F, Meyer U, Kubler NR, Naujoks C. Comparison of various approaches for the treatment of fractures of the mandibular condylar process. J Craniomaxillofac Surg. 2012 Dec;40(8):e397-401. doi: 10.1016/j.jcms.2012.02.012. Epub 2012 Mar 21.

  PMID: 22440318 RESULT

MeSH Terms

Conditions

Facial Nerve Injuries

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Senior supervisor Prof. Dr. Hairy El mossy will generate the allocation sequence.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: 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 .

Study Record Dates

• First Submitted: December 24, 2018
• First Posted: January 14, 2019
• Study Start: February 1, 2019
• Primary Completion: January 30, 2022
• Study Completion: May 8, 2022
• Last Updated: August 2, 2022

Record last verified: 2022-07

Locations

EG (1)