FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/12/029488 [Registered on: 02/12/2020] Trial Registered Prospectively
Last Modified On: 01/12/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Assessment of incidence of facial nerve functional deficit in open reduction and internal fixation of condylar fractures between transparotid and anterior parotid approach 
Scientific Title of Study   Comparative assessment of facial nerve function in transmassetric anterior parotid approach and transparotid approach for open reduction and internal fixation of Mandibular condylar fractures –A Randomized controlled clinical trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Subham S Agarwal 
Designation  Post graduate resident 
Affiliation  All India Institute of Medical Sciences- Raipur 
Address  Division of oral and maxillofacial surgery, department of Dentistry, C block, main dome, all India institute of medical sciences- Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  9789525733  
Fax    
Email  subhamag.agarwal@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Santhosh Rao 
Designation  Associate professor 
Affiliation  All India Institute of Medical Sciences- Raipur 
Address  Department of Dentistry, c block, main dome ,all India institute of medical sciences- raipur

Raipur
CHHATTISGARH
492099
India 
Phone  9981525599  
Fax    
Email  santhosh@aiimsraipur.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Santhosh Rao 
Designation  Associate professor 
Affiliation  All India Institute of Medical Sciences- Raipur 
Address  Department of Dentistry, c block, main dome, all India institute of medical sciences- raipur

Raipur
CHHATTISGARH
492099
India 
Phone  9981525599  
Fax    
Email  santhosh@aiimsraipur.edu.in  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences- Raipur 
 
Primary Sponsor  
Name  All India Institue of Medical Sciences Raipur 
Address  AIIMS- Raipur, Great Eastern Road, Tatibandh 
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 Santhosh Rao  All India Institute of Medical Sciences  Department of Dentistry, c block, main dome, all India institute of medical sciences- Raipur, Raipur- 492099
Raipur
CHHATTISGARH 		 9981525599

santhosh@aiimsraipur.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee - AIIMS RAIPUR  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Transmassetric Anterior Parotid Approach  A 3–4 cm skin incision will be made 0.5cm below the ear lobule in the retromandibular region. The skin flap will be raised forward to expose the anterior or top edge of the parotid myofascial layer. The subcutaneous tissues superficial to the superficial muscular aponeurotic system (SMAS) will be dissected anterior and superior, aiming to the fracture. Then, the parotid myofascia will be selectively stripped according to the different sites of the condylar fracture to pull the parotid tissue backward and expose the masseter and periosteum attached on the surface of the condylar process. Next, with blunt dissection, the masseter muscular fibers will be gently divided in a fashion that parallels the facial nerve fibers. Through the dissection of the masseter muscle, the mandibular periosteum will be reached, incised, and elevated until the fracture stumps appears 
Comparator Agent  Transparotid approach  A 3–4 cm skin incision will be made 0.5cm below the ear lobule in the retromandibular region. The dissection will be carried out in the sub-dermal fat plane. The parotid capsule, whichappears as a white glistening layer will be incised. The gland will be then blunt dissected in an anteromedial direction towards the posterior border of the mandible. This will be done by inserting a curved haemostat and spreading it open parallel to the expected direction of the branches of the facial nerve. The posterior border of the mandible will be identified and the pterygomasseteric sling incised. The masseter later will be stripped along with the periosteum from the angle of the mandible along the posterior border, as high as possible, exposing the fracture site.  
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  i. Patients above 12 years of age.
ii. Patients with unilateral condylar neck and sub-condylar fractures of jaw.
iii. Patients with bilateral condylar fracture but being surgically treated only on one side.
 
 
ExclusionCriteria 
Details  i. Fractures of the condylar head
ii. Bilateral condylar fractures being surgically reduced on both sides
iii. History of operations in the retromandibular region
iv. Traumatic open lacerations in the condylar region
v. Preoperative injury to the facial nerve or parotid gland
vi. Parotid gland disease
vii. Overt psychological disturbance
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary objective of assessing the facial nerve function will be done both clinically and using a standard procedure. T pre-framed scales like that of House- Brackmann. Procedural assessment is planned to be done by electrophysiological measures like Electromyography (EMG  Data will be collected using EMG at week 1, week 4, week 12 if feasible 
 
Secondary Outcome  
Outcome  TimePoints 
i. Extent of exposure will be reported based on the surgical exposure of the fractured site achieved and the anatomic landmarks of the extent of the exposure. Whether it was adequate or did the surgeon face any particular difficulty with the approach. Linear measurements of the extent of exposure shall be measured on the intraoperative photographs.
ii. Operating time- a stopwatch will be used to measure the time from making an incision to full exposure of the fracture site.
 		 intra- operatively 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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   N/A 
Date of First Enrollment (India)   02/12/2020 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Patient will be recruited only after approval of the study from the institutional ethics committee- AIIMS-Raipur.
Participant will be included into the study only if they fit in the inclusion criteria provided and after availing informed consent in their own language.
The participant will be followed up for a due course of 3 months after recruitment to achieve the primary objective.
Total duration planned to achieve the sample size= 44 is of 2 years but is subjected to change depending upon the reporting of cases

 
Close