FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/10/037566 [Registered on: 26/10/2021] Trial Registered Prospectively
Last Modified On: 26/10/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Dentistry
Other (Specify) [Complications of surgical apporaches in condylar fracutres of Mandible]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two different surgical operation techniques for lower jaw fractures 
Scientific Title of Study   Complications and time required for surgical access with retromandibular transparotid and anteroparotid transmasseteric approaches in management of mandibular condylar fracture: A prospective randomised clinical study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pareeksit Bagchi 
Designation  Resident 
Affiliation  MGM Dental College and Hospital 
Address  Dept of Oral and Maxillofacial Surgery, 4th Floor MGM Dental College and Hospital Sector 1 Kamothe Navi Mumbai

Raigarh
MAHARASHTRA
410209
India 
Phone  9322190927  
Fax    
Email  pareeksitbagchi@yahoo.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sunil Sidana 
Designation  Professor 
Affiliation  MGM Dental College and Hospital 
Address  Dept of Oral and Maxillofacial Surgery 4th Floor MGM Dental College and Hospital Sector 1 Kamothe Navi Mumbai

Raigarh
MAHARASHTRA
410209
India 
Phone  9820798821  
Fax    
Email  drsunilsidana@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sunil Sidana 
Designation  Professor 
Affiliation  MGM Dental College and Hospital 
Address  Dept of Oral and Maxillofacial Surgery 4th Floor MGM Dental College and Hospital Sector 1 Kamothe Navi Mumbai

Raigarh
MAHARASHTRA
410209
India 
Phone  9820798821  
Fax    
Email  drsunilsidana@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi Mission (MGM) dental College and hospital kamothe sector 1 Navi Mumbai 410209 
 
Primary Sponsor  
Name  Dept of Oral and Maxillofacial Surgery 
Address  MGM Dental College and Hospital Sector 1 Kamothe Navi Mumbai 410209 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pareeksit Bagchi  Mahatma Gandhi Mission (MGM)dental College and hospital  Room number 3 fourth floor department of oral and maxillofacial surgry MGM dental college building MGM Campus MGM Dental College and Hospital Sector 1 Kamothe Navi Mumbai 410209
Raigarh
MAHARASHTRA 
9322190927

pareeksitbagchi@yahoo.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Review Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: T888||Other specified complications of surgical and medical care, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Anteroparotid Transmasseteric Appraoch  Group B Comprising of 15 patients with subcondylar fractures of the mandbile will be operated for open reduction and internal fixation with this approach only once intraoperatively. Patient will be followed up for 2 weeks post surgery 
Comparator Agent  Transparotid Approach  Group A Comprising of 15 patients with subcondylar fractures of the mandbile will be operated for open reduction and internal fixation with this approach only once intraoperatively. Patient will be followed up for 2 weeks post surgery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Participants in the age group of 18 – 60 years.
2. Participants with unilateral/bilateral condylar fractures indicated for open reduction.
3. Participants with unilateral/bilateral condylar fractures along with other concomitant fractures of mandible indicated for open reduction.
4. Participants who have sustained fracture in the past two weeks.
5. Subject willingness to participate in the study. 
 
ExclusionCriteria 
Details  1. Participants with history of uncontrolled diabetes mellitus, prolonged steroid therapy, compromised immunity and associated bone
pathology.
2. Intracapsular Condylar fracture.
3. Undisplaced fractures of Mandibular Condylar fracture.
4. Patients with high condylar fractures.
5. Patients who have undergone open reduction and internal fixation for condylar fractures previously.
6. 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. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
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  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/11/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Not applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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 fixation 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 significant shortening of the mandibular ramus on the fractured side though bite forces did not show any significant 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 – 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 fixation of condylar fractures. The parameters evaluated are: time required to expose the condylar fracture site and the occurrence of salivary fistula, 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
 
Close