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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.


 
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