FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/03/083522 [Registered on: 26/03/2025] Trial Registered Prospectively
Last Modified On: 26/03/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Designing of a new fixation device for lower jaw and compare the efficacy with conventional fixation device. 
Scientific Title of Study   Design development,Biomechanical validation and Clinical evaluation of a novel miniplate design for Mandible angle fracture management:Two phase 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 Manju Kurakar 
Designation  Reader PhD student 
Affiliation  Sinhgad Dental college and hospital Pune 
Address  H601 Greens society, Opp Pudumjee paper mill Thergaon pune
Room no 5 Department of Oral and Maxillofacial Surgery Sinhgad Dental college and Hospital ,Vadagaon Budruk Pune
Pune
MAHARASHTRA
411033
India 
Phone  8600633012  
Fax    
Email  makurakar13@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr RK Suryavanshi 
Designation  Professor and Head 
Affiliation  Sinhgad Dental college and hospital Pune 
Address  Department of Oral and Maxillofacial surgery Sinhgad Dental college and Hospital ,Vadagaon Budruk Pune

Pune
MAHARASHTRA
411041
India 
Phone  9922994797  
Fax    
Email  oralsurgery.sdch@sinhgad.edu  
 
Details of Contact Person
Public Query  
Name  Dr RK Suryavanshi 
Designation  Professor and Head 
Affiliation  Sinhgad Dental college and hospital Pune 
Address  Department of Oral and Maxillofacial surgery Sinhgad Dental college and Hospital ,Vadagaon Budruk Pune

Pune
MAHARASHTRA
411041
India 
Phone  9922994797  
Fax    
Email  oralsurgery.sdch@sinhgad.edu  
 
Source of Monetary or Material Support  
Department of Oral and maxillofacial surgery Romm no 5 Sinhgad dental college and hospital Pune India 411033 
 
Primary Sponsor  
Name  sinhgad dental college and hospital Pune 
Address  sinhgad dental college and hospital vadagaon budruk Pune 411033 India 411033 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manju Kurakar  sinhgad dental college  Room no. 5 Department of Oral and Maxillofacial surgery. Sinhgad dental college and hospital Vadagaon Budruk Pune 411033
Pune
MAHARASHTRA 		 8600633012

makurakar13@gmail.com 
Dr RK Suryavanshi  Smt Kashibai Memorial medical college and hospital  Room no 28 Department of Oral and Maxillofacial surery Dental Satellite center. Smt Kashibai Memorial medical college and hospital Narhe Pune 411041
Pune
MAHARASHTRA 		 99229947

makurakar13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitionalethicalcommittee Sinhgad dental college and hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S026||Fracture of mandible,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group A:single straight miniplate fixation.(Conventional plate)  stage 1 conventional miniplate is fixed at mandible angle fracture created on computational mandible models and polyurethrane mandible stage 2(clinical study) Group A is fixed with single straight miniplate at mandible angle fracture patients 
Intervention  Group B New design miniplate fixation group  Stage 1 It will be done using computational mandible models & Polyurethrane mandible. Angle fracture will be fixed with new design miniplate. Stage 2(clinical study) Group B will be fixed with New design miniplate in mandible angle fractures patients. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients with Mandible angle fracture.
2. Patients of age group 18-60yrs
3. Patient under ASA I & ASA II
 
 
ExclusionCriteria 
Details  1.Patients with comminuted fracture at angle region.
2. Patients under ASA III & ASA IV
3. Patients with gross infection.
4.Patients who are not fit for surgery.
5. Oral submucous fibrosis patients(OSMF)
6. Patient who is not willing to participate

 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
evaluate and compare new design miniplate efficacy biomechanically and clinically.  4year 
 
Secondary Outcome  
Outcome  TimePoints 
• To validate and compare the biomechanical behaviour of new miniplate system with conventional system.

stage II
• To evaluate and compare the treatment outcome of new miniplate system with conventional miniplate system.
• To evaluate and compare the functional stability of new miniplate fixation with conventional miniplate system.
 		 2year 
 
Target Sample Size   Total Sample Size="28"
Sample Size from India="28" 
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)   15/04/2025 
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="3"
Months="6"
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  

The angle is one of the most frequent fractured sites after traumatic events involving the mandible.The optimal treatment of angle fractures remains controversial. Biomechanical studies on champy’s technique revealed that single miniplate on superior border has least resistance to lateral displacement and torsional force. Placement of two miniplate needs intraoral and extraoral approach/transbuccal approach. This practice increases periosteal stripping and compromises blood supply. Simultaneous intraoral and extraoral approach/transbuccal approach increases the risk of bacterial contamination , infection, increases operating time, risk of facial nerve injury and hypertrophic scar. The proposed research project aims to develop a novel single miniplate design that can be easily adapt and fix across fracture segments of mandible angle in biplanar fashion by intraoral approach. It shouId have minimal implant volume, but provides optimal biomechanical stability, functional stability and patient tolerance.

Objective To design a new miniplate system for mandible angle fracture management, evaluate and compare its efficacy biomechanically and clinically.

Study design-Two stage study

 

Stage 1: Randomised control trial using Computational mandible models & polyurethane mandible models.

              Evaluation and comparison of biomechanical stability and stress distribution of miniplate, screws and underlying bone using Finite element analysis. Validation of biomechanical characteristics using UTM machine.

 

Stage 2: Randomised control clinical trial

 Patients with Mandible angle fracture are selected into group A and B. Group A: Single straight miniplate fixation group(conventional) Group B: New miniplate design fixation group

Treatment outcome(Plate fixation time, Neurosensory function, Wound healing status) and Functional stability assessment are assessed and compared in both groups.

RESEARCH QUESTION

Is there any difference in biomechanical stability and clinical efficacy between single miniplate and new miniplate design for mandible angle fracture management?

 

 
Close