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CTRI Number  CTRI/2018/09/015596 [Registered on: 05/09/2018] Trial Registered Prospectively
Last Modified On: 31/12/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Comparision of treatment outcomes of two surgical techniques namely transparotid and transmasseteric anterior parotid used for management of fractures below the condyle of lower jaw 
Scientific Title of Study   Randomized controlled trial to evaluate the treatment outcomes of trasparotid and transmasseteric anterior parotid approaches to treat mandibular subcondylar fractures. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jeetendra Mandal 
Designation  Junior Resident  
Affiliation  All India Institute of Medical Sciences 
Address  first floor, Dept of OMFS CDER AIIMS New Delhi 29

South
DELHI
110029
India 
Phone    
Fax    
Email  jeetenmandal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ongkila Bhutia 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Dept of Oral and Maxillofacial Surgery First Floor, CDER AIIMS New Delhi 29

South
DELHI
110029
India 
Phone  9313349564  
Fax    
Email  dr.ongkila@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jeetendra Mandal 
Designation  Junior Resident  
Affiliation  All India Institute of Medical Sciences 
Address  first floor, Dept of OMFS CDER AIIMS New Delhi 29

South
DELHI
110029
India 
Phone    
Fax    
Email  jeetenmandal@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciecnes, New Delhi, India 
 
Primary Sponsor  
Name  All India Institute of medical sciences  
Address  Ansari Nagar new delhi 29 
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 Jeetendra Mandal  All India Institute of Medical Sciences, AIIMS.  Department of Oral and Maxillofacial Surgery, First Floor CDER AIIMS NEW DELHI
South
DELHI 
9871337532

jeetenmandal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH, AIIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  untilateral or bilateral mandibular subcondylar fracture.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  between two surgical technique, anterio parotid and transpaortid  evaluation of facial nerve injury following subcondylar fractures 
Comparator Agent  Facial nerve injury after surgical management of subcondylar fracture  Facial nerve status of operated patients is compared in both the groups 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  unilateral and bilateral subcondylar fracture  
 
ExclusionCriteria 
Details  medically compromised patients
pregnant patient  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Facial nerve injury encountered in both surgical approaches  Post operative day 1, day 7, after 1 month and after 3 month. 
 
Secondary Outcome  
Outcome  TimePoints 
Time taken from incision to exposure of fracture site  During time of surgery 
Suture Site Infection  Post operative day 1, day 7, after 1 month and after 3 months. 
Parotid Fistula  Post operative day 1, day 7 , after 1 month and after 3 months. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "49"
Final Enrollment numbers achieved (India)="49" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/09/2018 
Date of Study Completion (India) 30/07/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  
As reported in literature, mandibular condylar fractures accounts up to 17.5% - 52% of total mandibular fractures. There are various surgical approaches available in literature for ORIF of subcondylar fracture. Among extraoral approaches, retromandibular transparotid approach has been the approach of choice for many surgeons. Recently, retromandibular transmasseteric anterior parotid approach has been associated with less facial nerve palsy reported in literature, though there is paucity. So this study was designed to evaluate the efficacy these two approaches for treatment of subcondylar fractures. 53 cases were included and divided into 2 groups: group A in which 26 cases were treated with retromandibular transmasseteric anterior parotid approach and group B in which 27 patients were treated with retromandibular transparotid approach. Patients were randomized into both groups as per computer generated randomization table provided by Department of Biostatistics, AIIMS. These patients were followed up at postoperative day 1, day 7, 1 month and 3 month. Evaluation of facial nerve status was the primary outcome of the study and time taken for fracture exposure, blood loss during exposure, postoperative sialocele or parotid fistula, surgical site infection, scar and radiographic evaluation of fixation site were secondary outcomes.
The mean age of patients in group A and group B was 26.38 (18-52) and 24.11 (18-36) years respectively. Group A consisted of 22 males and 4 females, whereas, group B consisted of 25 males and 2 females. The most common mode of trauma for enrolled patients was road traffic accident, 65.3% in group A and 74% in group B, followed by assault, fall and sports injury was least. 22 patients in group A and 21 patients in group B had unilateral subcondylar fractures whereas, 4 patients in group A and 6 patients in group B were had bilateral subcondylar fracture. In group A, 11 cases had laterally displaced, 7 cases had medially displaced and 8 cases had non-displaced condyle. Similarly, in group B, 14 patients had laterally displaced, 6 patients medially displaced and 8 patients had non-displaced condyle. 19 cases in group A and 20 cases in group B had non-dislocated condyle whereas, 7 patients in each group had dislocated condyle. The mean deviation of condyle in group A and group B was 23.84 and 31.48 degree respectively. Mean preoperative mouth opening in group A and group B was 15.19mm and 19.18 mm respectively. 21 patients in group A and 23 patients in group B had deranged occlusion, whereas, 5 patients in group A and 4 patients in group 
had acceptable occlusion. The mean interval between trauma and surgery was 8.3 days and 8.1 days in group A and B respectively.
The results of the study showed that the mean exposure time in group A and group B was 19.88 minutes and 14.48 minutes respectively. The mean blood loss in group A and group B was 9.69mL and 8.98mL respectively. None of the patients in group A had any facial nerve paresis, neither transient nor permanent. However, in group B, 2 patients had transient facial nerve injury postoperatively which resolved after 3 months. In both groups, 2 patients developed sialocele and none of them had parotid fistula. 1 patient in group B had surgical site infection postoperatively, other than that no patients enrolled in study showed any sign of surgical site infection. 3 patients in each group was not satisfied with scar after 3 months. In group A, 3 patients showed plate fracture at 3 month follow up. In all of these patients, osteosynthesis was done with 2 non-parallel 2mm miniplates. In our study, facial nerve injury associated with retromandibular transparotid approach was more as compared to retromandibular transmasseteric anterior parotid approach, though statistically not significant. 
It can be concluded that the differences in efficacy of retromandibular transmasseteric anterior parotid and retromandibular transparotid approach are comparable in terms of adequacy of exposure, time taken for exposure, blood loss during exposure, incidence of facial nerve injury postoperatively and other complications like sialocele, parotid fistula, unaesthetic scar and plate fracture postoperatively. Surgical approach for surgical management of condylar fractures should be decided based on level of fracture, anatomic factors of patient, surgical skill of the surgeon and available armamentarium. Further studies with larger sample size can be planned for Comparison of these approaches to further the literature.
 
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