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CTRI Number  CTRI/2025/06/089229 [Registered on: 20/06/2025] Trial Registered Prospectively
Last Modified On: 19/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluate and compare bite force and chewing efficiency in patients with unilateral subcondyle fractures treated either surgically or non-surgically using bite scan and jaw tracker  
Scientific Title of Study   A Randomized control trial to compare comprehensive kinematic outcome of unilateral subcondyle fracture patient treated with either - conservative or surgical method 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rudramurthe G 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Division of Oral and Maxillofacial surgery, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi(South).

South West
DELHI
110029
India 
Phone  9597109605  
Fax    
Email  rudramurthe@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ongkila Bhutia 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Division of Oral and Maxillofacial surgery, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi(South).

South West
DELHI
110029
India 
Phone  9313349564  
Fax    
Email  dr.ongkila@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ongkila Bhutia 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Division of Oral and Maxillofacial surgery, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi(South).

South West
DELHI
110029
India 
Phone  9313349564  
Fax    
Email  dr.ongkila@gmail.com  
 
Source of Monetary or Material Support  
Department of Oral and Maxillofacial surgery,Center for Dental Education and research All India Institute of Medical Sciences New Delhi - 110029 
 
Primary Sponsor  
Name  Rudramurthe.G 
Address  Department of Oral and Maxillofacial surgery,Center for Dental Education and research All India Institute of Medical Sciences New Delhi - 110029 
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 Rudramurthe G  All India Institute of Medical Sciences, New Delhi  Division of Oral and Maxillofacial surgery, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi(South).
South West
DELHI 
09597109605

rudramurthe@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, All India Institute of Medical Sciences  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  Conservative method(MMF)  Intermaxillary fixation with an arch bar and wires for a time period of (2-3 weeks) Followed by aggressive physiotherapy (maximum mouth-opening exercise, excursive movements)  
Comparator Agent  Open reduction internal fixation (ORIF) method  Condylar fractures will be manually reduced and fixed with 2mm two mini plates using retromandibular approach.MMF with light elastics if required will be done for 3 to 5 days. Postoperative instructions regarding mouth opening exercises and physiotherapy regimen will be advised to the patients.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients having unilateral sub-condyle fracture of the mandible
Patients who give informed written consent.
 
 
ExclusionCriteria 
Details  1.Panfacial fractures patients
2.Pregnant patient.
3.Immunocompromised patient.
4.Patients with active or chronic infection with respect to preauricular region
5.Patients with metabolic diseases
6.The patient with  TMJ dysfunction.
7.Patient with connective tissue disorders. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Bite force- computerized occlusion analysis system.
Mandibular movements - jaw tracker  
Baseline (Pre-op), 1 month, 3 months, and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Functional occulsion -Yes/No
Temporomandibular joint pain- Yes/No
Dehiscence – Yes/No
Surgical site infection (SSI) – Yes/No
Hardware Failure-Yes /No
Facial nerve palsy - Yes / No 
Baseline (Pre-op), 1 month, 3 months, & 6 months 
 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   01/07/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/07/2025 
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 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 - NO
Brief Summary  

Mandibular fracture is one of the most common fractures in maxillofacial trauma. They account for around 45% of maxillofacial injuries, of which condylar fractures form a large proportion, contributing to between 17.5% and 52% of mandibular fractures .  Subcondylar fractures comprise 25% – 35% of all mandibular fractures The most common cause of mandibular condylar fracture is road traffic accidents followed by assault, stumbling, sports injuries, falls from height, and industrial accidents and sports injuries . Individuals sustaining condylar fractures present with a wide variety of clinical symptoms. In unilateral condylar fracture, there is ipsilateral gagging of occlusion, contralateral side open bite, midline deviation to the ipsilateral side while opening the mouth, pain, and tenderness on the preauricular region on the same side. In bilateral condylar fracture, loss of vertical height results in an anterior open bite with posterior gagging and pain in the preauricular region bilaterally. Limited mandibular movements such as maximal mouth opening, laterotrusive movement, and protrusive movement .

Bite force in patients with symptoms of dysfunction of the masticatory system is lower than in healthy people and increases as the symptoms disappear . The mainstay in diagnosis includes clinical symptoms followed by two-dimensional radiographs such as Orthopantomogram and Postero-anterior skull view. However, the gold standard in diagnosis and deciding treatment modality is computed tomography .

The treatment modalities advocated for the sub-condyle fracture are the non-operative treatment and operative treatment. Non-operative or conservative treatment aims to produce a bony union where there are no displacement or minimally displaced fracture segments, in case of dislocation of fracture condyle, to produce an acceptable functional pseudoarthrosis by re-education of neuromuscular pathways. The patient is treated by conservative intermaxillary for 2 to 3 weeks followed by active jaw movement exercises. Operative treatment is done by open reduction and internal fixation of the fracture with mini bone plates and screws.

Efficient evaluation of dental occlusion and masticatory function can bring relevant information to decide on the type of treatment to be performed/indicated . Closed treatment relies on the plasticity of the condyle head during recovery, whereas open treatment is challenging and risks facial nerve injury. Based on what has been previously exposed, there is the need to search, specifically, for muscle functioning standards and bite force of the oral-motor system of patients with mandibular unilateral sub-condyle fracture, aiming to guide the therapeutic approach and establish parameters to determine the Functional pathology prognosis.

 The objective of the present study is to measure and compare the bite force using T-scan and  3D mandibular border movements using jaw tracker after the management of unilateral subcondyle fracture of the mandible with either ORIF or conservative management.

 

 

 

 

 

 

 

 

 

 

 

 

 

 


 

 

 

 

 

 
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