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CTRI Number  CTRI/2026/01/102150 [Registered on: 27/01/2026] Trial Registered Prospectively
Last Modified On: 22/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   "Transparotid versus Anteroparotid Transmasseteric Techniques in management of Condylar fractures"- A Randomized Controlled Trial. 
Scientific Title of Study   "Comparative analysis of Retromandibular approaches to the Condyle: Transparotid versus Anteroparotid Transmasseteric Techniques"- A Randomized Controlled Trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Nishant Rathi 
Designation  Junior Resident 
Affiliation  Subharti Dental College and Hospital 
Address  Subharti Dental College, Swami Vivekanand Subharti University, Subharti Puram, NH-58, Delhi-Haridwar ByPass Road, Meerut.

Meerut
UTTAR PRADESH
250005
India 
Phone  9971765803  
Fax  0121-3058030  
Email  nishantrathi803@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Prajesh Dubey 
Designation  Professor 
Affiliation  SUBHARTI DENTAL COLLEGE AND HOSPITAL 
Address  Subharti Dental College, Swami Vivekanand Subharti University, Subharti Puram, NH-58, Delhi-Haridwar ByPass Road, Meerut.

Meerut
UTTAR PRADESH
250005
India 
Phone  8923288468  
Fax  0121-3058030  
Email  drprajeshdubey@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Nishant Rathi 
Designation  Junior Resident 
Affiliation  Subharti Dental College and Hospital 
Address  Subharti Dental College, Swami Vivekanand Subharti University, Subharti Puram, NH-58, Delhi-Haridwar ByPass Road, Meerut.

Meerut
UTTAR PRADESH
250005
India 
Phone  9971765803  
Fax  0121-3058030  
Email  nishantrathi803@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Self 
Address  Subharti Dental College, Swami Vivekanand Subharti University Subhartipuram, Meerut, Uttar Pradesh 
Type of Sponsor  Other [Self] 
 
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 Nishant Rathi  Subharti Dental College  Department of Oral and Maxillofacial Surgery, Subharti Dental College, Swami Vivekanand Subharti University, Subharti Puram, NH-58, Delhi-Haridwar ByPass Road, Meerut.
Meerut
UTTAR PRADESH 		 09971765803

nishantrathi803@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
University Ethics Committee Medical, Swami Vivekanand Subharti University Subhartipuram, Meerut, Uttar Pradesh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Retromandibular Anteroparotid Transmasseteric Approach in Management of Condylar fracture  Open reduction internal fixation of condylar fractures via retromandibular anteroparotid transmasseteric approach 
Comparator Agent  Retromandibular Transparotid Approach in management of condylar fractures  Open reduction internal fixation of condylar fractures via retromandibular transparotid approach 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients above 16 years of age.
Condylar fractures indicated for open reduction and internal fixation on clinical as well as radiological basis.
Dentulous or partially edentulous patients .
Mental status permitting on adequate neuromotor examination. 
 
ExclusionCriteria 
Details  Patients below 16 years of age.
Patients with bleeding disorders, eg. Haemophilia.
Patients with preoperative facial nerve paralysis.
Completely edentulous patients.
Patients not fit for surgery under General anesthesia. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Facial nerve weakness  1st day, 1st week, 1 month, 3 month 
 
Secondary Outcome  
Outcome  TimePoints 
Status of occlusion  1st day, 1st week, 1 month, 3 month 
Maximal interincisal opening  1st day, 1st week, 1 month, 3 month 
Fracture site exposure time  Intraoperatively 
Wound dehiscence  1st week, 1 month, 3 month 
Parotid fistula  1st week, 1 month, 3 month 
Scar  1 month, 3 month 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   09/02/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  09/02/2026 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="6"
Days="1" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [nishantrathi803@gmail.com].

  6. For how long will this data be available start date provided 15-05-2027 and end date provided 19-12-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
This randomized controlled trial includes 20 patients (10 patients for each approach) with mandibular condylar fractures, who will undergo open reduction and internal fixation. In case of bilateral condylar fractures considering 1 fracture site as 1 patient. In all these patients, pre-operative diagnostic radiographs- 3D-CT (3 dimensional computed tomography) of the face, chest X-ray, ECG (electrocardiograph), and laboratory investigations including hematological investigations followed by post- operative OPG (orthopantomogram) scan will be done. Patients will be followed up and specified parameters will be recorded postoperatively on 1st day, 1st week, 1st month and 3rd month.
The study is designed to compare the time taken for exposing the fracture site intra-operatively and compairing post-operative complications – maximal interincisal opening, facial nerve weakness using House - Brackman Scale, infection and wound dehiscence using visual description of WUWHS SWD grading system according to tissue layers involved in the dehiscence (WUWHS, 2018), parotid fistula formation and scar using Stony Brook’s Scar evaluation scale among the two approaches. Any complications encountered during or after the surgery will be managed in accordance with standard medical protocols.
 
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