| CTRI Number |
CTRI/2018/01/011493 [Registered on: 23/01/2018] Trial Registered Prospectively |
| Last Modified On: |
16/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening
Dentistry
Behavioral |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Dental health education classes for school children |
|
Scientific Title of Study
|
Effectiveness of a school oral health education intervention among 6-12 year old children in Thiruvananthapuram educational district: 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 Neethu Suresh |
| Designation |
Ph.D Scholar |
| Affiliation |
Sree Chitra Tirunal Institute for Medical Sciences and Technology |
| Address |
PhD room 1, PhD Division, Third floor, Department of public health, Achutha Menon Centre for Health Science Studies,
Sree Chitra Tirunal Institute for Medical Sciences and Technology,
Trivandrum.
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9895471757 |
| Fax |
|
| Email |
neethusuresh@ymail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Raman Kutty |
| Designation |
Professor and Head |
| Affiliation |
Sree Chitra Tirunal Institute for Medical Sciences and Technology |
| Address |
HOD room, First floor, Department of Public Health, Achutha Menon Centre for Health Science Studies,
Sree Chitra Tirunal Institute for Medical Sciences and Technology,
Trivandrum.
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9847060199 |
| Fax |
|
| Email |
kuttyr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neethu Suresh |
| Designation |
Ph.D Scholar |
| Affiliation |
Sree Chitra Tirunal Institute for Medical Sciences and Technology |
| Address |
PhD room 1, PhD Division, Third floor, Department of Public Health, Achutha Menon Centre for Health Science Studies,
Sree Chitra Tirunal Institute for Medical Sciences and Technology,
Trivandrum.
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9895471757 |
| Fax |
|
| Email |
neethusuresh@ymail.com |
|
|
Source of Monetary or Material Support
|
| PhD Division, Department of Public Health, Achutha Menon Centre for Health Science Studies,
Sree Chitra Tirunal Institute for Medical Sciences and Technology,
Trivandrum,
Kerala.
695011 |
|
|
Primary Sponsor
|
| Name |
Sree Chitra Tirunal Institute for Medical Sciences and Technology |
| Address |
PhD room 1, PhD division, Department of Public Health,
Achutha Menon Centre for Health Science Studies, Sree Chitra Tirunal Institute for Medical Sciences and Technology,
Trivandrum,
Kerala.
695011 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Neethu Suresh |
Sree Chitra Tirunal Institute Of Medical Sciences and Technology |
PhD room 1, PhD division, Department of Public Health, Achutha Menon Centre for Health Science Studies,
Trivandrum,
Kerala.
695011
Thiruvananthapuram
KERALA |
9895471757
neethusuresh@ymail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
K02 Dental caries and
K05 Gingivitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
One session of oral health education class and leaflets on oral hygiene status improvement. |
All the children in the control group will receive one session of oral health education class and leaflets describing the importance of oral hygiene, how to improve oral hygiene status. |
| Intervention |
School oral health education intervention. |
School oral health education classes will be taken by a dentist over a period of 3 months. Classes will focus on the importance of oral hygiene, how to maintain oral hygiene, tooth brushing technique, importance of regular dental checkup, consequences of poor oral hygiene. Children in the intervention group will also receive leaflets describing the importance of oral hygiene and how to improve oral hygiene. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
6-12-year-old children studying in government or government-aided schools in Thiruvananthapuram educational district. |
|
| ExclusionCriteria |
| Details |
Children above 12 years and below 6 years, children studying in private schools. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of 6-12 year old school children whose oral hygiene status has improved significantly. |
Three months after intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in the prevalence of gingivitis among 6-12 year old school children.
Proportion of 6-12 year old school children whose oral health related knowledge, attitude and practices has improved significantly. |
Three months after intervention. |
|
|
Target Sample Size
|
Total Sample Size="450"
Sample Size from India="450"
Final Enrollment numbers achieved (Total)= "453"
Final Enrollment numbers achieved (India)="453" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/01/2018 |
| Date of Study Completion (India) |
21/02/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Oral diseases are a major public health problem for children and oral health education (OHE) is an important method of preventive approach to address this problem. OHE intervention could be more beneficial for participants if it is guided by health behaviour theories. The most appropriate time to provide OHE to children is 6-12 years because it is the time of mixed dentition; first permanent teeth erupt by the age of 6 years. Schools are considered to provide the most favourable environment to impart oral health education to children because they provide an efficient and effective way to reach out to children. In India, there is a lack of studies to evaluate the effectiveness of health behaviour theory-based school OHE interventions.Major objective
1. To find out the effect of a school oral health education intervention on the oral hygiene status among 6-12-year-old school children in Thiruvananthapuram educational district.
Minor objectives
1. To estimate the prevalence of dental caries among 6-12-year-old school children in Thiruvananthapuram educational district.
2. To estimate the prevalence of gingivitis among 6-12-year-old school children in Thiruvananthapuram educational district.
3. To find out the effect of a school oral health education intervention on the prevalence of gingivitis among 6-12-year-old school children in Thiruvananthapuram educational district.
4. To find out the effect of a school oral health education intervention on oral health-related knowledge, attitude and practices among 6-12-year-old school children in Thiruvananthapuram educational district.The study participants will be 6-12-year-old school children studying in government and government-aided schools in Thiruvananthapuram educational district. The study will be conducted in three phases.Phase 1: Development of a school oral health education intervention plan for 6-12-year-old children.Phase 2: Implementation of the school oral health education intervention for 6-12-year-old children.Phase 3: Implementation of the school oral health education intervention for 6-12-year-old children.
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