| CTRI Number |
CTRI/2018/01/011407 [Registered on: 18/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
23/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Educational intervention] |
| Study Design |
Other |
|
Public Title of Study
|
Oral health curriculum for school children |
|
Scientific Title of Study
|
Effectiveness of an oral health curriculum in improving the oral health knowledge, attitude and practice among school children in Ernakulam: An intervention study
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vineetha K |
| Designation |
post graduate trainee |
| Affiliation |
Amrita school of dentistry |
| Address |
Department of Public Health Dentistry,
Amrita School of Dentistry, AIMS,
Ponekkara P.O., Kochi
Ernakulam
KERALA
682041
India |
| Phone |
8289959380 |
| Fax |
|
| Email |
kvineetha2016@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandrashekar J |
| Designation |
Professor |
| Affiliation |
Amrita school of dentistry |
| Address |
Department of Public Health Dentistry,
Amrita School of Dentistry, AIMS,
Ponekkara P.O., Kochi
Ernakulam
KERALA
682041
India |
| Phone |
9481789572 |
| Fax |
|
| Email |
sekarcandra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijay kumar S |
| Designation |
Reader |
| Affiliation |
Amrita School of Dentistry |
| Address |
Department of Public Health Dentistry,
Amrita School of Dentistry, AIMS,
Ponekkara P.O., Kochi
Ernakulam
KERALA
682041
India |
| Phone |
8086089492 |
| Fax |
|
| Email |
vijaykumars@aims.amrita.edu |
|
|
Source of Monetary or Material Support
|
| Amrita School of Dentistry,
Ponekkara, Kochi -682041 |
|
|
Primary Sponsor
|
| Name |
Amrita School of Dentistry |
| Address |
Amrita School of Dentistry, AIMS,
Ponekkara P.O., Kochi
|
| Type of Sponsor |
Private medical college |
|
|
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 |
| Vineetha K |
Amrita Vidyalayam |
Senior Secondary School, Kunnumpuram, Edapally North P.O., Kochi, Kerala 682024.
Ernakulam
KERALA |
8289959380
kvineetha2016@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Amrita Institute of Medical Sciences. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Dental Caries |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oral health curriculum imparted by a dentist |
Oral health curriculum developed by investigators to be imparted by a dentist to the school children |
| Comparator Agent |
Oral health curriculum imparted by a school teacher |
Oral health curriculum developed by investigators to be imparted by a school teacher to the school children
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Students who are willing to participate in the study and who has given the informed consent. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The difference in knowledge, attitude and practice of oral health before and after incorporating an oral health curriculum in school children. |
1) Baseline
2) After 6 months
3) After 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The difference in knowledge, attitude and practice among school children before and after incorporation of school curriculum by a dental health professional and a school teacher |
1) Baseline
2) After 6 months
3) After 1 year |
|
|
Target Sample Size
|
Total Sample Size="900"
Sample Size from India="900"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="900" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2017 |
| Date of Study Completion (India) |
22/03/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study will be carried out in a private school following CBSE
board. An oral health curriculum customized for upper primary, lower primary
and high school children will be developed and this curriculum will be tested
for a period of one year. A cluster of one division from each standard from 1-
10th will be taken as the study arm. The other division of the same class will
be taken as the control arm.
After obtaining an informed consent from the selected children a
baseline data will be collected using a Knowledge, Attitude and Practices
questionnaire followed by oral examination from all the divisions.
The study arm will receive lectures , demonstration and activities according
to the developed oral health curriculum by a dentist. The control arm will be receiving the same education from a school teacher. The teaching programme will be carried once in every two
months by a student dentist and the class teacher.
The KAP questionnaire will be
administered to the participants after 6 months and I year from the start of
the study.
|