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CTRI Number  CTRI/2019/01/017199 [Registered on: 22/01/2019] Trial Registered Prospectively
Last Modified On: 21/01/2019
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Tooth fracture 
Scientific Title of Study   Knowledge, attitude and practice of management of dental trauma among medical professionals in Hassan, India. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Girish Babu KL 
Designation  Professor and Head 
Affiliation  Hassan Institiute of Medical Sciences 
Address  Department of Dentistry, Hassan Institute of Medical Sciences, Hassan

Hassan
KARNATAKA
573201
India 
Phone  9845340753  
Fax    
Email  docgirish77@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Girish Babu KL 
Designation  Professor and Head 
Affiliation  Hassan Institiute of Medical Sciences 
Address  Department of Dentistry, Hassan Institute of Medical Sciences, Hassan

Hassan
KARNATAKA
573201
India 
Phone  9845340753  
Fax    
Email  docgirish77@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Girish Babu KL 
Designation  Professor and Head 
Affiliation  Hassan Institiute of Medical Sciences 
Address  Department of Dentistry, Hassan Institute of Medical Sciences, Hassan

Hassan
KARNATAKA
573201
India 
Phone  9845340753  
Fax    
Email  docgirish77@gmail.com  
 
Source of Monetary or Material Support  
THERE ARE NO ANY MONETORY OR MATERIAL SUPPORT 
 
Primary Sponsor  
Name  Self 
Address  Department of Dentistry Hassan Institute of Medical Sciences Hassan 
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 Girish Babu KL  Hassan Institute of Medical Sciences  Department of Dentistry, Hassan Institute of Medical Sciences, Hassan
Hassan
KARNATAKA 
9845340753

docgirish77@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 
Healthy Human Volunteers  Healthy persons 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Medical professionals working in Hassan city  
 
ExclusionCriteria 
Details  Medical professionals not working in Hassan city
Medical professionals not willing to participate 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
At the end of study we will know the knowledge of medical doctors about emergency management of dental trauma  At the end of 1 year we will be able assess the knowledge of medical doctor about dental trauma management 
 
Secondary Outcome  
Outcome  TimePoints 
This helps for better patient care during the oro-facial trauma but interdisciplinary approach  Improves the prognosis of traumatized tooth 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
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)   31/01/2019 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   1. Díaz J, Bustos L, Herrera S, Sepulveda J. Knowledge of the management of paediatric dental traumas by non dental professionals in emergency rooms in South Araucanía, Temuco, Chile. Dent Traumatol 2009;25:611 9. 2. Holan G, Shmueli Y. Knowledge of physicians in hospital emergency rooms in Israel on their role in cases of avulsion of permanent incisors. Int J Paediatr Dent. 2003;13(1):13-9. 3. Addo ME, Parekh S, Moles DR, Roberts GJ.Knowledge of dental trauma first aid (DTFA): the example of avulsed incisors in casualty departments and schools in London. Br Dent J. 2007:202(10):1-6. 4. Subhashraj K. Awareness of management of dental trauma among medical professionals in Pondicherry, India. Dent Traumatol. 2009;25(1):92-4.  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

A cross-sectional study will be conducted among medical professionals working in Hassan city. The tool for data collection will be a questionnaire. The questionnaire will be developed by adapting the works of previous studies.

Procedure of the study will be explained to all medical professionals . Four hundred medical professionals willing to voluntarily participate in the study will be included. Written informed consent will be taken from them. On a specific day and time scheduled as per the convenience of them, the investigators will distribute the questionnaires personally to all the participants. They will be given 20 minutes to complete the questionnaire. Following they will be explained their role in emergency management of dental trauma. 

The data obtained from the study will be subjected to statistical analysis

 
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