| 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
|
|
|
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. |