CClinicalTrials.gg
CompletedNCT03803150Updated Aug 2, 2022

Evaluation of Preauricular Retromandibular Anteroparotid Versus Retromandibular Through Parotid Approach

An interventional study of PRA approach and RT approach in Subcondylar Process of Mandible Open Fracture and Facial Nerve Injuries, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-02.

Sponsored by Cairo University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Subcondylar Process of Mandible Open Fracture
  • Facial Nerve Injuries

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  1. Intraoral treatment of subcondylar fracture.
  2. Incooperative patients.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    PRA approach

    PRA extends downward in curvilinear fashion in cervicomastoid skin crease

    Procedure: PRA approach

  • Active comparator
    RT approach

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

    Procedure: RT approach

Interventions

  • ProcedurePRA approach

    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.

  • ProcedureRT approach

    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.

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: Concerning the facial injury will be at 6 months

  2. Minimize salivary fistula

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

    Time frame: Salivary fistula at 1 week

Secondary outcomes

  1. 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

    Time frame: at 6 months

06

Study locations

1 site
  • Faculty of dental and oral medicine / Cairo University
    Cairo, 12816, Egypt
07

References and documents

Publications

  • 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. PubMed 19231779 ↗
  • 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. PubMed 20461515 ↗
  • 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. PubMed 12140424 ↗
  • 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. PubMed 21119445 ↗
  • 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. PubMed 15620776 ↗
  • 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. PubMed 2212022 ↗
  • 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. PubMed 14762747 ↗
  • 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. PubMed 10503856 ↗
  • 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. PubMed 23395651 ↗
  • 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. PubMed 17113444 ↗
  • 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. PubMed 269890 ↗
  • 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. PubMed 1527657 ↗
  • 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. PubMed 22440318 ↗

Individual participant data

Plan to share: Undecided — Once I finished the study I will share the data

08

Registry details

Key details

Study ID
NCT03803150
Lead sponsor
Cairo University
Responsible party
Hani Taher Hibatullah Ali (Principle Investigator, Cairo University) — Principal investigator
First posted
Jan 14, 2019
Start date
Feb 1, 2019
Primary completion
Jan 30, 2022
Completion
May 8, 2022
Last update
Aug 2, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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