Comparison of two different surgical operation techniques for lower jaw fractures

Phase 4

Recruiting

Conditions: Medical and Surgical, (2) ICD-10 Condition: T888||Other specified complications of surgical and medical care, not elsewhere classified,

Registration Number: CTRI/2021/10/037566

Lead Sponsor: Dept of Oral and Maxillofacial Surgery

Brief Summary: 25 to 45% of all the mandibular fractures are mandibular condylar fractures. The reason for the high incidence of condylar fractures is the peculiar anatomy of the mandible which ensures dissipation of forces along the bone allowing the weakest part of the condylar neck to fracture, thus preventing transfer of forces to the Cranium. Optimal osteosynthesis of such a fracture can be attained only by rigid internal ï¬xation after anatomic reduction. Studies by Ellis and Throckmorton published in 2000 conclude that patients who had ORIF had better restitution of condyle position and reinforcement of their fractured condylar processes. Patients who underwent closed reduction had displacement of the condylar process in the coronal plane, which persisted for up to 1 year, and had a signiï¬cant shortening of the mandibular ramus on the fractured side though bite forces did not show any signiï¬cant difference. To get direct vision of the fractured ends and mobilization of the displaced segments it is essential to gain complete exposure of the surgical field. Distance between the incision line and fracture level often necessitates excessive retraction of tissues resulting in nerve injuries and tissue damage. Appropriate choice of surgical approach gains importance in reducing the post operative complications especially while dealing with less accessible fracture sites like the sub-condylar region. Conventional exposure techniques like preauricular, submandibular, intraoral, and retromandibular incisions are the most commonly used access routes for the ORIF of a subcondylar fracture as endoscopes are yet to gain popularity in India. The intraoral route although desirable as it avoids facial scarring provides limited exposure for manipulation and fixation of the fracture site. Therefore the extra oral route is the most commonly selected one. However, each of these incision have varying degrees of complications reported due to the proximity to two vital structures namely the facial nerve and the parotid gland. The retro-mandibular approach described by Hinds and Girroti in1967 has been the most popular, as it involves a minimal working distance between the incision and the fracture. While using a retromandibular incision, the approach to the fracture site can be either through the parotid gland, as in the retromandibular transparotid approach, or the parotid maybe bypassed by use of the retromandibular transmasseteric anterior parotid (TMAP) approach. Here, we will try to compare two most popular variations of retromandibular approach that is â€“ retromandibular transparotid approach; retromandibular anteroparotid transmasseteric approach. The purpose of this study will be to compare the time required to expose the condylar fracture site and also the rate of complications encountered on using different incisions to access the fracture site for the open reduction and internal ï¬xation of condylar fractures. The parameters evaluated are: time required to expose the condylar fracture site and the occurrence of salivary ï¬stula, infection, and injuries to the seventh cranial nerve.

Clinical Significance of the Study:

This study will help in decision making regarding the choice of approach between the Retromandibular Transparotid and Anteroparotid Transmasseteric approach based on the ease of surgical access and incidence of complications

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 30

Inclusion Criteria

Participants in the age group of 18 â€“ 60 years.
Participants with unilateral/bilateral condylar fractures indicated for open reduction.
Participants with unilateral/bilateral condylar fractures along with other concomitant fractures of mandible indicated for open reduction.
Participants who have sustained fracture in the past two weeks.
Subject willingness to participate in the study.

Exclusion Criteria

Participants with history of uncontrolled diabetes mellitus, prolonged steroid therapy, compromised immunity and associated bone pathology.
Intracapsular Condylar fracture.
Undisplaced fractures of Mandibular Condylar fracture.
Patients with high condylar fractures.
Patients who have undergone open reduction and internal fixation for condylar fractures previously.
Participants with tendency for keloid formation and those with contused lacerated wounds, abrasions or Avulsive soft tissue injuries around the area of extraoral incision.
(pre existing scar) 7.
Presence of preinjury Facial nerve palsy.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complications and time required for each approach	Complications will be evaluated at post operative day 1 day 7 1 month and 2 months

Secondary Outcome Measures

Name	Time	Method
time required for each approach	Intraoperatively after incision till exposure of fracture
Post operative swelling	At 1 weeks and 2 weeks postoperatively
Parotid fistula	At 1 week and 2 weeks

Trial Locations

Locations (1): Mahatma Gandhi Mission (MGM)dental College and hospital
🇮🇳
Raigarh, MAHARASHTRA, India
Mahatma Gandhi Mission (MGM)dental College and hospital
🇮🇳Raigarh, MAHARASHTRA, India
Dr Pareeksit Bagchi
Principal investigator
9322190927
pareeksitbagchi@yahoo.in