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CTRI Number  CTRI/2023/04/051542 [Registered on: 12/04/2023] Trial Registered Prospectively
Last Modified On: 11/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluation of dexterity with mirror neuron therapy. 
Scientific Title of Study   Efficacy of Mirror Neuron Therapy on dexterity in bilateral cleft lip Surgical simulator Model.A Randomized Controlled Trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gauri Camblay 
Designation  MDS 1 
Affiliation  Dr D Y Patil Dental College and Hospital Dr D Y Patil Vidyapeeth  
Address  Department of Oral and Maxillofacial Surgery Dr D Y Patil Dental College and Hospital Dr D Y Patil Vidyapeeth Sant Tukaram Nagar Pimpri Pune 411018
Aster 3 Sukhwani Campus Sant Tukaram Nagar Pimpri Pune 411018
Pune
MAHARASHTRA
411018
India 
Phone  9767098428  
Fax    
Email  gauricamblay@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Lakshmi Shetty  
Designation  Professor 
Affiliation  Dr D Y Patil Dental College and Hospital Dr D Y Patil Vidyapeeth  
Address  Department of Oral and Maxillofacial Surgery Dr D Y Patil Dental College and Hospital Dr D Y Patil Vidyapeeth Sant Tukaram Nagar Pimpri Pune 411018
H 605 Mahindra Royale Sant Tukaram Nagar near Lotus Court Pune 411018
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 D Y Patil Dental College and Hospital Dr D Y Patil Vidyapeeth  
Address  Department of Oral and Maxillofacial Surgery Dr D Y Patil Dental College and Hospital Dr D Y Patil Vidyapeeth Sant Tukaram Nagar Pimpri Pune 411018
H 605 Mahindra Royale Sant Tukaram Nagar near Lotus Court Pune 411018
Pune
MAHARASHTRA
411018
India 
Phone  9673006494  
Fax    
Email  drlakshmishetty21@gmail.com  
 
Source of Monetary or Material Support  
Dr D Y Patil Dental College Dr D Y Patil vidyapeeth Sant Tukaram Nagar Pune-411018 
 
Primary Sponsor  
Name  Dr Gauri Camblay 
Address  Dr D Y Patil Dental College and Hospital Sant Tukaram Nagar 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 
Dr Gauri Camblay  Dr D Y Patil dental colege and hospital  Department of Oral and Maxillofacial Surgery Room no 9 Third floor Dr D Y Patil Dental College and Hospital Dr D Y Patil Vidyapeeth Sant Tukaram Nagar Pune Pimpri Maharashtra
Pune
MAHARASHTRA 		 9767098428

gauricamblay@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Suturing on a cleft lip surgical simulator model with mirror neuron therapy  Suturing excercises without the help of mirror neuron therapy and ball excercises for hand grip strength 
Comparator Agent  Suturing on a cleft lip surgical simulator model without mirror neuron therapy  Suturing excercises without the help of mirror neuron therapy and ball excercises for hand grip strength 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  All the residents and newly joined assistant professors in the department of oral and maxillofacial surgery from Dr D Y Patil Dental College And Hospital 
 
ExclusionCriteria 
Details  Residents and newly joined assistant professors who have diabetes mellitus
Residents and newly joined assistant professors who had recent upper limb trauma
Residents and newly joined assistant professors who have problems related to vision
Residents and newly joined assistant professors who have neurological disorders 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Mirror neurons get activated when we observe your own actions. For example: Suturing on a bilateral cleft lip simulator and squeezing ball excercises by using an optical mirror. In a cleft lip surgery, through a cleft lip simulator there is an improved surgical performance, the simulator has led to a significance improvement in surgical knowledge, procedural confidence, performance and it is well received as an educational tool. Mirror neuron therapy with cleft lip excercises on a simulator increases the skills and training needed for a good practice.  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   17/04/2023 
Date of Study Completion (India) 02/10/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Dexterity is important to investigate the efficacy of the hand strength and hand eye co-ordination of the person.For Oral and Maxillofacial Surgery dexterity is needed to increase the surgical performance of the surgeons.Neural changes called as neuroplasticity allows the brain to modify its organisation with the connection of new neurons called as mirror neurons.Mirror neuron therapy on a  surgical simulator to  increase the skills and training for a good practice. 
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