| 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
|
|
|
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
|
|
|
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 |