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CTRI Number  CTRI/2025/04/085422 [Registered on: 23/04/2025] Trial Registered Prospectively
Last Modified On: 22/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparision between 5 hole strut plate and 4 hole delta plate for treatment of fractures of the head of the lower jaw. 
Scientific Title of Study   3D Strut plate versus delta plate in management of mandibular condylar fracture- a prospective randomised clinicoradiographic comparative study 
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 Ayushi Jha 
Designation  PG Resident 
Affiliation  Sardar Patel Post Graduate Institute of Dental and Medical Sciences 
Address  02, Department of Oral and Maxillofacial Surgery, Sardar Patel Post Graduate Institute of Dental and Medical Sciences Chaudhary Vihar Utrathia Raebareily Road Lucknow 226025 Uttar Pradesh

Lucknow
UTTAR PRADESH
226025
India 
Phone  9643280799  
Fax    
Email  ayushi80799@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gaurav Singh 
Designation  Professor and Head 
Affiliation  Sardar Patel Post Graduate Institute of Dental and Medical Sciences 
Address  02, Department of Oral and Maxillofacial Surgery, Sardar Patel Post Graduate Institute of Dental and Medical Sciences Chaudhary Vihar Utrathia Raebareily Road Lucknow 226025 Uttar Pradesh

Lucknow
UTTAR PRADESH
226025
India 
Phone  9415086536  
Fax    
Email  dr.gaurav1502@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Gaurav Singh 
Designation  Professor and Head 
Affiliation  Sardar Patel Post Graduate Institute of Dental and Medical Sciences 
Address  02, Department of Oral and Maxillofacial Surgery, Sardar Patel Post Graduate Institute of Dental and Medical Sciences Chaudhary Vihar Utrathia Raebareily Road Lucknow 226025 Uttar Pradesh

Lucknow
UTTAR PRADESH
226025
India 
Phone  9415086536  
Fax    
Email  dr.gaurav1502@gmail.com  
 
Source of Monetary or Material Support  
Department of Oral and Maxillofacial Surgery, Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Lucknow, Uttar Pradesh, India Pin code- 226025 
 
Primary Sponsor  
Name  Sardar Patel Post Graduate Institute of Dental and Medical Sciences 
Address  Raebareily road Lucknow- 226025 
Type of Sponsor  Research institution 
 
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 Ayushi Jha  Out Patient Department of Oral and Maxillofacial Surgery  Department of Oral and Maxillofacial Surgery Sardar Patel Post graduate institute of Dental and Medical Sciences, Lucknow
Lucknow
UTTAR PRADESH 
9643280799

ayushi80799@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Intitutional Ethical Committee  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  3D Strut Plate  Using a conventional retromandibular incision, the fracture site is exposed. The Langenbeck retractor, which is positioned at the sigmoid notch, will be used for the reduction. Next, a 2 mm system 5-hole Strut subcondylar plate made of titanium will be positioned at the fractured site, with its short arm situated slightly below the sigmoid notch and its long arm parallel to the posterior border of the ramus of the mandible. The plate will be secured in place by five 8 mm titanium screws. After fixing the plates, Maxillomandibular Fixation will be released and occlusion will be checked. The extraoral incision will be sealed with 4-0 prolene on the skin and 3-0 vicryl in the deep layers. Along with Maxillo-Mandibular Fixation training elastics will also be placed on all the patients since second post-operative day for 2 weeks. Patients will be evaluated immediately following surgery, as well as 1, 2, 3, and 6 weeks later. 2 weeks following surgery, Maxillo Mandibular Fixation will be released, and following the fourth post-operative week, arch bars will be taken out. All the patients to be given a high dose of antibiotics and analgesics post-operatively. Patients will receive strict instructions regarding oral hygiene. 
Comparator Agent  Delta Plate  Using a conventional retromandibular incision, the fracture site is exposed. The Langenbeck retractor, which is positioned at the sigmoid notch, will be used for the reduction. The fracture site will have a delta plate placement, with the base of the plate pointing in the direction of the angle of mandible. The plate will be secured in place by four 8 mm titanium screws. After fixing the plates, Maxillomandibular Fixation will be released and occlusion will be checked. The extraoral incision will be sealed with 4-0 prolene on the skin and 3-0 vicryl in the deep layers. Along with Maxillo-mandibular Fixation training elastics will also be placed on all the patients since second post-operative day for 2 weeks. Patients will be evaluated immediately following surgery, as well as 1, 2, 3, and 6 weeks later. 2 weeks following surgery, Maxillo-Mandibular Fixation will be released, and following the fourth post-operative week, arch bars will be taken out. All the patients to be given a high dose of antibiotics and analgesics post-operatively. Patients will receive strict instructions regarding oral hygiene. 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Condylar fractures with or without occlusal discrepancy.
Displaced and undisplaced both types of condylar fracture.
American Society of Anaesthesiologist Classification (ASA) I and II patient.
Condylar fractures: unilateral or bilateral
 
 
ExclusionCriteria 
Details  Edentulous mandible fracture.
Pre-existing discrepancies in skeleton
Pathological problems that were present in the temporomandibular joints before.
Condylar head fracture
Condylar fracture associated with any other mid-face fracture.
Severely comminuted along with infected fracture.
Patients who are not fit to undergo procedure under general anaesthesia.
Previous history of irradiation of head and neck area 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary Outcome is to compare the clinical and radiological outcomes of 3D strut plate with delta plate in the treatment for condylar fractures of mandible and to asses occlusal discrepancy, Maximum interincisal opening, bite force, fracture stability, restoration of ramus height and post operative complications  The estimated time may range upto 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcome is to assess pain, facial nerve funtion, post operative complications  The estimated time may range upto 6 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   03/05/2025 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

The data for this study will be collected from the patients with fractures of condyle of mandible who visit the Out Patient Department (OPD) of Oral and Maxillofacial Surgery, Sardar Patel Post Graduate Institute of Dental and Medical Sciences, and Dr. O.P. Chaudhary Hospital and Research Centre, Lucknow, will be the subjects of the study. Each patient will be asked for written informed consent after being fully informed about the procedure’s nature, expected results, and potential side effects. Patient will be selected irrespective of caste, creed, sex, religion or socio-economic status. Each patient will be randomly allocated to group A and group B using lottery method. Surgical procedure will be performed under General Anaesthesia. Patient will be laid on the operating table and Intravenous line will be secured. Anaesthesia will be induced by Propofol and maintained by Halothane and O+ N2O. Nasotracheal intubation will be done. Surgical site preparation, draping, and maxillomandibular fixation will be done. Local infiltration will be given. Following the preparation of the surgical sterile field, surface markings will be made and the zygomatic arch, mandibular condyle, and ramus up to the angle will be identified. After that, the fracture end will be described. There will be a conventional retromandibular incision made. The periosteum is raised and the fracture is located once the surface of the bone is reached. The Langenbeck retractor, which is positioned at the sigmoid notch, will be used for the reduction. Next, a 2 mm system 5-hole Strut subcondylar plate made of titanium will be positioned at the fractured site, with its short arm situated slightly below the sigmoid notch and its long arm parallel to the ramus’s posterior border. The plate will be secured in place by five 8 mm titanium screws, or the fracture site will have a delta plate placement using four 8mm screws, with the base of the plate pointing in the mandibular angle’s direction. After fixing the plates, Maxillo-mandibular Fixation will be released and occlusion will be checked. The extraoral incision will be sealed with 4-0 Prolene on the skin and 3-0 Vicryl in the deep layers. Along with Maxillo-mandibular Fixation training elastics will also be placed on all the patients since second post-operative day for 2 weeks. Patients will be evaluated immediately following surgery, as well as one, two, three, and six weeks later. Two weeks following surgery, Maxillo-mandibular Fixation will be released, and following the fourth post-operative week, arch bars will be taken out. All the patients to be given a high dose of antibiotics and analgesics post-operatively. Patients will receive strict instructions regarding oral hygiene.

 
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