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CTRI Number  CTRI/2025/08/092606 [Registered on: 07/08/2025] Trial Registered Prospectively
Last Modified On: 16/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes
Behavioral
Other (Specify) [Educational intervention]  
Study Design  Cluster Randomized Trial 
Public Title of Study   The best method to educate about First aid management regarding dental trauma for Non-dental Health Professionals 
Scientific Title of Study   Effectiveness and acceptability of First aid dental trauma educational intervention for Non-dental Health Professionals 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Hitesh Chander Mittal 
Designation  Associate professor and Incharge 
Affiliation  ESIC dental college and hospital  
Address  Department of Pediatric and Preventive dentistry, Sedam Road, Kalaburagi, Karnataka

Gulbarga
KARNATAKA
585101
India 
Phone  08607707755  
Fax    
Email  dr.hiteshmittal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Hitesh Chander Mittal 
Designation  Associate professor and Incharge 
Affiliation  ESIC dental college and hospital  
Address  Department of Pediatric and Preventive dentistry, Sedam Road, Kalaburagi, Karnataka

Gulbarga
KARNATAKA
585101
India 
Phone  08607707755  
Fax    
Email  dr.hiteshmittal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Hitesh Chander Mittal 
Designation  Associate professor and Incharge 
Affiliation  ESIC dental college and hospital  
Address  Department of Pediatric and Preventive dentistry, Sedam Road, Kalaburagi, Karnataka

Gulbarga
KARNATAKA
585101
India 
Phone  08607707755  
Fax    
Email  dr.hiteshmittal@gmail.com  
 
Source of Monetary or Material Support  
ESIC Dental College and Hospital , Kalaburagi 
 
Primary Sponsor  
Name  ESIC dental College and Hospital 
Address  ESIC Dental College and Hospital ,Sedam Road, Kalaburagi, Karnataka, India Pincode-585106 
Type of Sponsor  Other [Government Dental College and Hospital] 
 
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 Hitesh Chander Mittal  ESIC Dental college   Department of Pediatric and Preventive dentistry, Sedam Road, Kalaburagi, Karnataka
Gulbarga
KARNATAKA 
08607707755

dr.hiteshmittal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-ESIC DENTAL COLLEGE, KALABURAGI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  healthy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Brochure for dental trauma information   Participants will be provided with Brochure with colored images for first Aid related to dental trauma. The educational brochure will contain information about tooth fracture, and tooth avulsion, and their management. These materials will be prepared in English language with coloured pictures. The pre and post intervention effectiveness will be evaluated using Knowledge Attitude and practice- selfadministered questionnaire tool. 
Intervention  Simulated demonstration  Participants will be briefly described and video will be played to demonstrate how to act for dental trauma or first Aid related to dental trauma.The educational workshop with video simulated demonstration will contain information about tooth fracture, and tooth avulsion, and their management. These materials will be prepared in English language with coloured pictures. The pre and post intervention effectiveness will be evaluated using Knowledge Attitude and practice- selfadministered questionnaire tool. Data collection tool regarding the emergency management of avulsed teeth will be collected using a self-administered questionnaire having questions that are close-ended. The questionnaire will be prepared in consultation with the pre-existing literature for KAP for medical professionals or school teachers. The questionnaire has been developed by adapting the works of previous studies. The developed questionnaire will be further validated by a group of experts in dental traumatology.  
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Non-dental health professionals 
 
ExclusionCriteria 
Details  dental professionals 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Centralized 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1To access the baseline KAP for dental trauma among non-dental health professionals
2. Change in knowledge after different training exercise at immediate post-intervention, and 03 months
 
Immediate post-intervention, and 03 months
 
 
Secondary Outcome  
Outcome  TimePoints 
2 Acceptability of the two different training programs
 
Immediate post-intervention, 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   Phase 4 
Date of First Enrollment (India)   25/08/2025 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 first aid/emergency management for traumatic dental injuries is crucial for preserving the natural smile. It is well documented that up to 66% of all emergency hospital visits for dental issues are related to traumatic dental injuries. Thus, medical professionals are typically responsible for managing the initial phase of dental trauma . However, studies have indicated that medical professionals’, and nursing professionals’ knowledge of dental trauma management is often lacking.  

Despite the importance of first aid for dental trauma, the provision of oral health education in undergraduate medical programs is reported to be minimal, and traumatic dental injury management is often non-existent.3 For instance, a study conducted among medical students in Melaka, Malaysia, found that 98.4% had low knowledge of the emergency management of tooth avulsion.

This gap in knowledge underscores the need for more comprehensive education on dental trauma management in medical curricula. This highlights the need for improved education and training in dental trauma management within the medical field. 

Worldwide, a lot of work has been conducted among school teachers, and efforts have been made to train school teachers in the emergency management of dental trauma. However, medical doctors would benefit from having more basic knowledge of dental anatomy, including the structure of the tooth and surrounding tissues, if they were trained for first aid treatment of tooth avulsion injury. There have been limited studies on the knowledge of medical professionals related to tooth avulsion in the Indian scenario.  thus, this study has been planned with aim to evaluate the effectiveness of ‘First aid dental trauma educational intervention’ for Non-     dental Health Professionals

 
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