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CTRI Number  CTRI/2022/09/045410 [Registered on: 12/09/2022] Trial Registered Prospectively
Last Modified On: 15/08/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Dentistry
Behavioral
Other (Specify) [Educational Intervention Trial]  
Study Design  Cluster Randomized Trial 
Public Title of Study   Oral health curriculum for high school children 
Scientific Title of Study   Effectiveness of an oral health curriculum in reducing dental caries increment and improving oral hygiene behaviour among school children of Ernakulam: A cluster-randomized 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 Hindol Das 
Designation  Ph.D. Scholar & ICMR Nurturing Clinical Scientist 
Affiliation  Amrita School of Dentistry 
Address  Department of Public Health Dentistry Amrita School of Dentistry Kochi 682041 Kerala

Ernakulam
KERALA
682041
India 
Phone  8910066125  
Fax    
Email  drhindolforu@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Chandrashekar Janakiram 
Designation  Professor & Head of Department 
Affiliation  Amrita School of Dentistry 
Address  Department of Public Health Dentistry Amrita School of Dentistry Kochi 682041 Kerala

Ernakulam
KERALA
682041
India 
Phone  9481789572  
Fax    
Email  sekarcandra@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Venkitachalam R 
Designation  Reader 
Affiliation  Amrita School of Dentistry 
Address  Department of Public Health Dentistry Amrita School of Dentistry Kochi 682041 Kerala

Ernakulam
KERALA
682041
India 
Phone  9895741775  
Fax    
Email  venkitr2006@gmail.com  
 
Source of Monetary or Material Support  
Amrita School of Dentistry, Amrita Institute of Medical Sciences, Kochi-682041, Kerala, India 
Indian Council of Medical Research (ICMR), V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi - 110029, India 
 
Primary Sponsor  
Name  Indian Council of Medical Research ICMR 
Address  V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi - 110029, India 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
Amrita School of Dentistry and Amrita Institute of Medical Sciences  Kochi-682041, Kerala, India 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Chandrashekar Janakiram  CBSE English Medium Schools  High Schools (CBSE) of Ernakulam district, Kerala, India.
Ernakulam
KERALA 
9481789572

sekarcandra@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Amrita Institute of Medical Sciences and Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Dental Caries (ICD-10 code K02) 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Oral Health Curriculum delivered by Dental Professional.  For group A, dental professional will impart the oral health curriculum to the school children. 
Intervention  Oral Health Curriculum delivered by Schoolteacher.  For group B, school teacher will impart the oral health curriculum to the school children. 
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  • High school students belonging to the age group of 13-15 years (from 8 to 10 standard/grade) will be selected.
• Students who are willing to participate in the study and who have given the informed consent (parental consent/assent).
 
 
ExclusionCriteria 
Details  • Students who are not willing to participate in the study and who do not provide the informed consent (parental consent/assent). 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in index scores (DMFT, OHI-S) and difference in knowledge, attitudes, and behaviours regarding oral hygiene post-intervention.  - Baseline
- After 1 year
- After 2 years 
 
Secondary Outcome  
Outcome  TimePoints 
Comparing index scores (DMFT, OHI-S) and knowledge, attitude, and behaviour scores between Dental professional & School teacher  - After 1 year
- After 2 years 
 
Target Sample Size   Total Sample Size="2000"
Sample Size from India="2000" 
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 3/ Phase 4 
Date of First Enrollment (India)   15/09/2022 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This study is a cluster-randomized trial design. The target population will be high school children from standard 8 to 10 of the age group 13-15 years. It is a parallel-group comparative trial with two arms having 1:1 distribution- group A and B with oral health curriculum intervention from Dental Professional and School teacher respectively. CBSE English medium high schools of Ernakulam district, Kerala is selected as clusters for the trial. Minimum cluster size is 20 students per school. The selected schools are randomized using lottery method. Total sample size is 2000 high school children. Data will be collected at baseline, after 1 year (mid-term) and 2 years (final) respectively. The outcome measures are DMFT (Decayed, Missing and Filled Teeth index), OHI-S (Oral Hygiene Index-Simplified, and KAB (Knowledge, Attitude & Behaviour). Data collection will be done by clinical oral examination and KAB questionnaire.

School oral health education programme delivered through an oral health curriculum intervention with oral hygiene instructions and demonstrations for oral health promotion will be implemented to the school children for a period of two years. One session will be conducted every four months. Curriculum will be divided into modules with age-appropriate instructions for the students. Lesson plans with instructor instructions, hands-on demonstrations, hand-outs or master copies for each child will be included in each module. The curriculum will include oral health topics.

We will measure the change in index scores (DMFT, OHI-S) and difference in knowledge, attitudes, and behaviours regarding oral hygiene post-intervention, i.e., after incorporation of oral health curriculum from the dental professional and schoolteacher. We will also compare and calculate the difference in effectiveness of the intervention between the dental professional and the school teacher.


 
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