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CTRI Number  CTRI/2025/07/090300 [Registered on: 07/07/2025] Trial Registered Prospectively
Last Modified On: 08/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   "Teaching children in Mannerwarlu communities in India about oral hygiene by using traditional rhymes as a fun and effective way to promote good dental care. 
Scientific Title of Study   Oral hygiene promotion among children in tribal(mannerwarlu) communitie in india using traditional rhyme (folk song) as a tool for oral hygiene promotion :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  Reshma Rameshrao Ghaytidak 
Designation  postgraduate student 
Affiliation  Dr. dy Patil dental college pimpri pune 
Address  Dr. dy Patil dental college department of public health dentistry 1st floor room no 5 pimpri pune

Pune
MAHARASHTRA
411018
India 
Phone  940303781  
Fax    
Email  ghaytidak.reshma@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Reshma Rameshrao Ghaytidak 
Designation  postgraduate student 
Affiliation  Dr. dy Patil dental college pimpri pune 
Address  Dr. dy Patil dental college department of public health dentistry 1st floor room no 5 pimpri pune


MAHARASHTRA
411018
India 
Phone  940303781  
Fax    
Email  ghaytidak.reshma@gmail.com  
 
Details of Contact Person
Public Query  
Name  Reshma Rameshrao Ghaytidak 
Designation  postgraduate student 
Affiliation  Dr. dy Patil dental college pimpri pune 
Address  Dr. dy Patil dental college department of public health dentistry 1st floor room no 5 pimpri pune


MAHARASHTRA
411018
India 
Phone  940303781  
Fax    
Email  ghaytidak.reshma@gmail.com  
 
Source of Monetary or Material Support  
Dr. dy Patil dental college department of public health dentistry 1st floor room no 5 pimpri pune 411018 
 
Primary Sponsor  
Name  DrDYPatil Dental College And Hospital Pimpri Pune 
Address  Dr. dy Patil dental college department of public health dentistry 1st floor room no 5 pimpri pune 411018 
Type of Sponsor  Research institution 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 
DrReshma Rameshrao Ghaytidak  Dr.D.Y.Patil Dental College And Hospital Pimpri Pune  Dr. dy Patil dental college department of public health dentistry 1st floor room no 5 pimpri pune 411018
Pune
MAHARASHTRA 		 940303781

ghaytidak.reshma@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr.D.Y.Patil Dental College And Hopital Pimpri Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy human volunteers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Traditional folk song   The content of the song will be a questionnaire. The song created will undergo pretesting regarding its fulfillment of the content by back translation of the song.  
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  Those children who are enrolled in Ashram Shala will be included. 
 
ExclusionCriteria 
Details  children who do not understand the Mannerwarlu language will be excluded. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Improvement in oral hygiene practices among Mannerwarlu tribal children, specifically measured through changes in toothbrushing habits. Reduction in debris index scores and increase in oral hygiene knowledge scores post-intervention compared to baseline.  basline 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison between intervention (folk song group) and control group in terms of Knowledge improvement, brushing habits  basline 
 
Target Sample Size   Total Sample Size="210"
Sample Size from India="210" 
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 1 
Date of First Enrollment (India)   18/07/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Not Applicable 
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
Modification(s)  
There is an urgent need for educational interventions among Nigerian children with several reports stating that many of them have poor oral hygiene knowledge and behavior . These interventions are particularly useful when they are carried out among children who are just forming behaviors that affect their health .
Efforts to improve oral hygiene awareness among tribal populations require a holistic approach that addresses socioeconomic factors, cultural sensitivities, educational background, and ease of understanding.
The effectiveness of songs, traditional melodies can be adapted to include lyrics that reinforce key oral hygiene concepts, leveraging the power of music to teach children the importance of brushing and maintaining good oral hygiene.
 
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