CTRI Number |
CTRI/2018/01/011366 [Registered on: 16/01/2018] Trial Registered Prospectively |
Last Modified On: |
29/11/2019 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Preventive Screening Dentistry Behavioral |
Study Design |
Cluster Randomized Trial |
Public Title of Study
|
School oral health program implemented by school health nurses and teachers in Kottayam, Kerala. |
Scientific Title of Study
|
Evaluation of a school oral health program among 12-14 year old children implemented by school health nurses and teachers in Kottayam – A Community 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 Vivek Narayan |
Designation |
Lecturer |
Affiliation |
Government Dental College Kottayam |
Address |
Department of Public Health Dentistry,
Government Dental College,
Gandhinagar P O,
Kottayam, Kerala
Kottayam KERALA 686008 India |
Phone |
|
Fax |
|
Email |
drviveknarayan@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Susan Thomas |
Designation |
Professor and HOD |
Affiliation |
Government Dental College Kottayam |
Address |
Department of Public Health Dentistry,
Government Dental College,
Gandhinagar P O,
Kottayam, Kerala
Kottayam KERALA 686008 India |
Phone |
|
Fax |
|
Email |
drsusanalex@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Vivek Narayan |
Designation |
Lecturer |
Affiliation |
Government Dental College, Kottayam |
Address |
Department of Public Health Dentistry,
Government Dental College,
Gandhinagar P O,
Kottayam, Kerala
Kottayam KERALA 686008 India |
Phone |
|
Fax |
|
Email |
drviveknarayan@gmail.com |
|
Source of Monetary or Material Support
|
Government Dental College
Gandhinagar P O
Kottayam Kerala
686008 |
|
Primary Sponsor
|
Name |
Government Dental College |
Address |
Government Dental College
Gandhinagar P O
Kottayam, Kerala
686008 |
Type of Sponsor |
Government 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 |
Dr Vivek Narayan |
Government Dental College Kottayam |
Government Dental College
Gandhinagar P O
Kottayam
Kerala Kottayam KERALA |
9895319384
drviveknarayan@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Instiutional Ethics Committee Government Dental College Kottayam |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Oral Health Problems
Dental Caries
Gingivitis |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Control Group |
Annual Screening |
Intervention |
Oral Health Education,Screening,
Prevention |
repeated Oral health education provided by School teachers,Screening performed by School health nurses once in 3 months,School based weekly topical fluoride mouth rinse |
|
Inclusion Criteria
|
Age From |
12.00 Year(s) |
Age To |
14.00 Year(s) |
Gender |
Both |
Details |
1.School children aged 12-14 years at baseline from Govt/ Govt. aided schools in Ettumanoor & Athirampuzha, Kottayam, Kerala.
2.Written informed consent from Parent/ Guardian and Principal of school.
|
|
ExclusionCriteria |
Details |
1. Children undergoing orthodontic treatment
2. Physically & mentally challenged children
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To compare the changes in Oral health determinant, knowledge, attitude and practices among beneficiaries of this program as compared to a control group |
6 months
1 year |
|
Secondary Outcome
|
Outcome |
TimePoints |
Proportion of untreated caries
caries increment |
6 months
1 year |
|
Target Sample Size
|
Total Sample Size="700" Sample Size from India="700"
Final Enrollment numbers achieved (Total)= "770"
Final Enrollment numbers achieved (India)="770" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
01/02/2018 |
Date of Study Completion (India) |
23/10/2019 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
23/10/2019 |
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Background
and Objectives
Low
oral health priority and poor access to dental care have contributed to large
unmet oral health needs in rural communities in developing nations such as India.
The role of school based oral health promotion delivered by teachers and school
health nurses has not been evaluated so far. This study compared the changes in
oral health knowledge, attitude, practices (KAP) and oral health indicators
among 12-14 year old children who received a school based oral health promotion
to age matched controls from a different panchayat.
Methods
A
school based cluster randomized design was used. The intervention, provided by
school teachers and school health nurses appointed by National Health Mission, consisted
of oral health education (once in 3 months), weekly classroom based sodium
fluoride mouth rinsing for one year and biannual oral health screening/
referral by school health nurses. The control arm did not receive these
interventions. Oral health indicators and KAP were evaluated at baseline and
one-year follow-up. KAP was assessed
using a self-administered questionnaire in Malayalam. Oral health indicators
included oral hygiene index simplified, net caries increments using DMFT/DMFS, prevented
fraction, number of sites with gingival bleeding, changes in care index,
restorative index, treatment index and dental attendance.
Results
The percentage
improvement in total KAP score, oral hygiene and gingival bleeding from
baseline to follow up was higher in the intervention group (p <0.05). Though the net caries
increment in DMFT and DMFS was higher in the control group, the difference was
not statistically significant. The prevented fraction for net caries increment
were 23.33% and 20.51% for DMFT and DMFS respectively. Students in the
intervention group had a higher proportion of dental attendance (OR 2.92, p <0.001). The changes in treatment
index, restorative index and care index were 20.5%, 14.5% and 5.6% respectively
in the intervention group. These were significantly higher than that observed
in the control group (p <0.001).
Conclusions
Inclusion
of available primary care auxiliaries like school health nurses and teachers in
oral health promotion is an effective and sustainable strategy to improve oral
health indicators and utilization in rural areas in Kerala. The adoption of
this school oral health policy will enable us to address the problems in oral
health and achieve progress at par with the excellent general health indicators
of Kerala. |