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CTRI Number  CTRI/2024/08/072898 [Registered on: 22/08/2024] Trial Registered Prospectively
Last Modified On: 20/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Physiotherapy (Not Including YOGA)
Other (Specify) [teaching]  
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Comparison of preclinical surgical skill of residents in mandibular fracture plating by intraoral approach with and without virtual reality training- A Randomized Controlled Trial  
Scientific Title of Study   Comparative evaluation of preclinical surgical performance of mandibular angle fracture plating by intraoral approach with and without virtual reality- 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  Sagar Sanjay Kadadhekar 
Designation  PG Student 
Affiliation  Dr DY Patil Dental College And Hospital Dr DY Patil Vidyapeeth pimpri Pune 
Address  Department of oral and maxillofacial surgery Dr DY patil Dental College And Hospital Dr DY Patil Vidyapeeth pimpri pune

Pune
MAHARASHTRA
411018
India 
Phone  7756060659  
Fax    
Email  sagarkadadhekat123@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Lakshmi Shetty 
Designation  Professor 
Affiliation  Dr DY Patil Dental College And Hospital Pimpri Pune 
Address  Department Of Oral And Maxillofacial Surgery OPD 9 Dr DY patil Dental College And Hospital Dr DY Patil Vidyapeeth pimpri pune

Pune
MAHARASHTRA
411018
India 
Phone  9673006494  
Fax    
Email  drlakshmishetty21@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Lakshmi Shetty 
Designation  Professor 
Affiliation  Dr DY Patil Dental College And Hospital Pimpri Pune 
Address  Deptartment Of Oral And Maxillofacial Surgery OPD 9 Dr DY patil Dental College And Hospital Dr DY Patil Vidyapeeth pimpri pune


MAHARASHTRA
411018
India 
Phone  9673006494  
Fax    
Email  drlakshmishetty21@gmail.com  
 
Source of Monetary or Material Support  
Deptartment Of Oral And Maxillofacial Surgery OPD 9 Dr DY patil Dental College And Hospital Dr DY Patil Vidyapeeth pimpri pune 
 
Primary Sponsor  
Name  Sagar Sanjay Kadadhekar 
Address  Deptartment Of Oral And Maxillofacial Surgery OPD 9 Dr DY patil Dental College And Hospital Dr DY Patil Vidyapeeth pimpri pune 
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 
Sagar Kadadhekar  Dr DY Patil Dental College And Hospital  Deptartment Of Oral And Maxillofacial Surgery OPD 9 Dr DY patil Dental College And Hospital Dr DY Patil Vidyapeeth pimpri pune
Pune
MAHARASHTRA 
7756060659

sagarkadadhekat123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Sub Committee Dr DY Patil Dental College And Hospital Dr. DY Patil Vidyapeeth, Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Residents of Oral and maxillo facial surgery trained with and without Virtual reality 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  conventional training  the residents will be trained conventional by senior professor for mandibular angle fracture plating by intraoral approach 
Intervention  Virtual reality training  Presurgical demonstraction of mandibular angle fracture plating by intraoral approach with the help of virtual realty the training will be done for 1 month 
 
Inclusion Criteria  
Age From  23.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  All the residents in the department of oral and maxillofacial surgery from Dr. D.Y. patil Dental College and Hospital. 
 
ExclusionCriteria 
Details  Residents who have problems related to vision.
Residents who have received training for mandibular angle fracture plating by intraoral approach with the help of oculus virtual reality.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
performance of residents with and without presurgical VR training for mandibular angle fracture plating by intraoral approach  performance will be assessed after 2 months of training at 6 month and 8 month interval 
 
Secondary Outcome  
Outcome  TimePoints 
hand skill, intrumentation, use of assisstance   1 month 
 
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   N/A 
Date of First Enrollment (India)   25/09/2024 
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="1"
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  

Surgical technique demonstration by traditional method is common, but training by virtual reality to trainees has come into trend from last one decade. It is seen that training the trainees by virtual reality demonstrate the procedure or technique in step wise and give complete idea of  procedure. 

Mandibular angle fracture is the most common fracture occurring in mandible and accounts 25% of occurrence. It is the most common region to fracture due to thinner cross sectional area, presence of third molar, and muscular force. Open reduction internal fixation is the standard treatment for the angle fracture of mandible.

Intraoral open reduction and fixation using a single miniplate ventral to oblique line of buccal cortex of mandible was described by Champy et al. Bending the plate and adapting to the ventral surface of oblique line needs good skill and technique. To acquire this skill first demonstration and practice is much important.

The most important goal of any training method is to increase the level of skill and understanding, but to date no studies have established a clear benefit of virtual reality training that transfers to oral and maxilla facial surgeon skill measured in the operating room.

The ultimate aim of this study is to evaluate and compare the preclinical surgical performance of oral maxillofacial surgery residents for intraoral mandibular fracture plating after virtual training.

 
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