| 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
|
|
|
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
|
|
|
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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