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
|
|
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
|
|
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.
|