| CTRI Number |
CTRI/2022/12/048304 [Registered on: 20/12/2022] Trial Registered Prospectively |
| Last Modified On: |
13/12/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry
Behavioral
Other (Specify) [Educational intervention] |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Oral health curriculum for school children |
|
Scientific Title of Study
|
Development and validation of oral health curriculum for schools in Kerala: A cluster-randomized controlled 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 Parvathy B |
| Designation |
Senior Research Fellow |
| Affiliation |
Amrita School of Dentistry |
| Address |
Department of Public Health Dentistry
Amrita School of Dentistry
Kochi
Kerala 682041
Ernakulam
KERALA
682041
India |
| Phone |
08129153947 |
| Fax |
|
| Email |
parvathysree7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandrashekar Janakiram |
| Designation |
Professor and Head of Department |
| Affiliation |
Amrita School of Dentistry |
| Address |
Department of Public Health Dentistry
Amrita School of Dentistry
Kochi
Kerala 682041
Ernakulam
KERALA
682041
India |
| Phone |
9481789572 |
| Fax |
|
| Email |
sekarcandra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hindol Das |
| Designation |
Clinical scientist |
| Affiliation |
Amrita School of Dentistry |
| Address |
Department of Public Health Dentistry
Amrita School of Dentistry
Kochi
Kerala 682041
Ernakulam
KERALA
682041.
India |
| Phone |
|
| Fax |
|
| Email |
drhindolforu@gmail.com |
|
|
Source of Monetary or Material Support
|
|
Amrita School of Dentistry, Amrita Institute of Medical Sciences campus, Kochi, Kerala-682041
|
| 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 |
Amrita Institute of Medical Sciences campus, Kochi,Kerala- 682041 |
|
|
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 |
Amrita School of Dentistry |
Department of Public Health Dentistry,
Amrita Institute of Medical Sciences campus
Ponekkara Kochi Kerala 682041
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K02||Dental caries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No intervention |
School children will follow the already existing health curriculum of their respective schools (grades1-7) |
| Intervention |
Oral Health Curriculum delivered by Dental Professional
|
For group A, dental professional will impart the oral health curriculum to the school children (grades 1-7).
|
| Intervention |
Oral health curriculum delivered by the school teacher |
For group B, volunteering school teacher will provide the oral health curriculum to the school children (grades 1-7) |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
i. Students of standards 1 to 7 in schools at Ernakulam and Kollam districts of Kerala
ii. Students who are willing to participate in the study and whose parents/ guardians have given the consent
|
|
| ExclusionCriteria |
| Details |
i. Students who are not willing to participate in the study.
ii. Students whose parents/ guardians do not give consent for participating in the study.
|
|
|
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 practices regarding oral hygiene
post-intervention
|
- Baseline
- After 1 year
- After 2 years
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Index and KAB Score comparison |
2 |
|
|
Target Sample Size
|
Total Sample Size="6000"
Sample Size from India="6000"
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)
|
27/12/2022 |
| 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 Applicable |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [parvathysree7@gmail.com].
- For how long will this data be available start date provided 01-01-2026 and end date provided 01-01-2029?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This is a cluster-randomized trial with the intervention arm receiving the developed oral health curriculum and the control arm continuing with the existing school health curriculum. The intervention arm is subdivided into two groups - group 1 where the curriculum will be administered by the dental professional and group 2 where the school teacher will administer the curriculum. The target population is children from grades 1-7 in CBSE, ICSE, and state syllabus schools in Ernakulam and Kollam districts in Kerala. Both English and Malayalam medium schools will be selected. Each school will be considered a cluster. The minimum cluster size is 20 students per school.
Selected schools are randomized using the lottery method. The total sample size is 6000. Data will be collected at baseline, after 1 year (mid-term), and after 2 years (final). The outcome measures are DMFT (Decayed Missing and Filled Teeth index), OHI-S (Oral Hygiene Index -simplified), and KAB (Knowledge, Attitude and Behaviour). Data collection will be carried out by clinical oral examination and KAB questionnaire.
The developed oral health curriculum will comprise oral hygiene instructions and demonstrations for oral health promotion which will be implemented to the schoolchildren for a period of two years. One session will be conducted every four months. The curriculum will be divided into modules with age-appropriate instructions for students. Lesson plans with instructions, hands-on demonstrations, handouts, or master copy will also be provided.
Change in index scores (DMFT, OHI-S) and difference in knowledge, attitude, and behaviour regarding oral hygiene post-intervention will be measured and a comparison of scores between intervention and control groups will be done. We will also compare and calculate the scores of the intervention group between participants taught by dentist and school teacher |