CTRI Number |
CTRI/2012/07/002786 [Registered on: 11/07/2012] Trial Registered Retrospectively |
Last Modified On: |
10/07/2012 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Preventive Screening Dentistry |
Study Design |
Cluster Randomized Trial |
Public Title of Study
|
Impact of oral health training to Anganwadi workers on Oral Health Status of Preschool Children of Chandigarh. |
Scientific Title of Study
|
Improving the Oral Health Status of Preschool Children in Anganwadi Settings of Chandigarh. |
Trial Acronym |
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Secondary IDs if Any
|
Secondary ID |
Identifier |
Micro/2011/5961 dated 4/3/2011 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Sonu Goel |
Designation |
Assistant Professor |
Affiliation |
PGIMER |
Address |
School of Public Health
PGIMER
Chandigarh
Chandigarh CHANDIGARH 160014 India |
Phone |
|
Fax |
|
Email |
sonugoel007@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
Name |
Sonu Goel |
Designation |
Assistant Professor |
Affiliation |
PGIMER |
Address |
School of Public Health
PGIMER
Chandigarh
Chandigarh CHANDIGARH 160014 India |
Phone |
|
Fax |
|
Email |
sonugoel007@yahoo.co.in |
|
Details of Contact Person Public Query
|
Name |
Sonika |
Designation |
Research Scholar |
Affiliation |
Panjab University, Chandigarh |
Address |
Centre for Public Health,
Deptt. of IEAST
Panjab University, Chandigarh
Chandigarh CHANDIGARH 160014 India |
Phone |
9878933725 |
Fax |
|
Email |
sonikagoel007@yahoo.com |
|
Source of Monetary or Material Support
|
National Rural Health Mission, U.T Chandigarh |
|
Primary Sponsor
|
Name |
National Rural Health MissionUT Chandigarh |
Address |
NRHM
Sector 22
Chandigarh |
Type of Sponsor |
Government funding agency |
|
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 Sonu Goel |
Anganwadi centres of Chandigarh |
Department of Social Welfare,
U.T Chandigarh Chandigarh CHANDIGARH |
9914208027
sonugoel007@yahoo.co.in |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institute Ethics Committee, PGIMER, Chandigarh |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Oral health Status |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Oral Health Training Package-1 (Knowledge Based)
|
Cluster-1 (project-1 of Anganwadi Workers)was provided with Oral Health training package-1 i.e. power-point presentation on oral hygiene. Also, provided with a story on oral health and a poster for each anganwadi centre.
Cluster-2 (project-2 of Anganwadi Workers)- Oral Health training package-2 (power-point presentation on oral hygiene plus demonstration of skills. |
Comparator Agent |
Oral Health Training Package-2 (Knowledge and skill based) |
Cluster-2 (project-2 of Anganwadi Workers)was provided with Oral Health training package-2 which contained power-point presentation on oral hygiene plus demonstration of skills like correct toothbrushing technique, plaque disclosure, flossing etc. Also, provided with a story on oral health and a poster for each anganwadi centre. |
|
Inclusion Criteria
|
Age From |
3.00 Year(s) |
Age To |
6.00 Year(s) |
Gender |
Both |
Details |
1. All the children aged 3-6 years attending the AWC (Anganwadi Centre) on the date of visit, whose parents consented for the study.
2. All the Anganwadi Workers (AWW) present on the day of training
|
|
ExclusionCriteria |
Details |
1. The children absent on the day of visit
2. Children less than 3 years or more than 6 years
3. Parents of children who denied consent. |
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Pre-numbered or coded identical Containers |
Blinding/Masking
|
Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
1. Change in knowledge of Anganwadi workers in oral health
2. Change in oral habits and practices (thumb sucking, tooth brushing frequency, mouth rinsing) of children after imparting oral health training packages to AWW.
|
6 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
1. Prevalence of dental caries amongst children
2. Change in caries activity by means of Snyder test |
6 months |
|
Target Sample Size
|
Total Sample Size="495" Sample Size from India="495"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
01/10/2010 |
Date of Study Completion (India) |
Date Missing |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
Unpublished |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
The present study was conducted to estimate the prevalence of dental caries and gingival disease among preschool children attending anganwadi centers and to compare the impact of two oral health training packages on knowledge and skills of anganwadi workers (AWW) and on oral health status and habits of preschool children attending anganwadi centers (AWC). The sample size was determined taking alpha error as 0.05 (likelihood of association by chance alone as less that 5%), beta error 0.20 (i.e. statistical power of the study as 80%), and assuming baseline poor dental hygiene of the children as 40% and expected decrease in poor dental hygiene by intervention (oral health training package) to be approximately 15% (effect size) and drop-out rate as 10%. Thus a minimum sample size of 495 children was estimated. Assuming that an anganwadi will contain around 20-25 children in age group of 3-6 years, a total of 21 anganwadis were selected for the study by lottery method.
Baseline oral health examination of children present on the day of visit was done in their respective anganwadis using plain mouth mirror and probe in the broad day-light. Caries was recorded based on dmft index as per WHO criteria .The mothers were also interviewed regarding oral habits of their children .A total of 534 anganwadi children in 3-6 year age group from 21 AWC were examined. Samples of saliva (0.2 ml) of children of AWC were taken in tubes with Snyder media to detect caries susceptibility and incubated at 37 degrees C. The readings were taken at 24, 48, 72 & 96 hrs to detect the colour change in media.
After the survey, the anganwadi workers of Project-1 (n=112) were provided with oral health training package-1 (knowledge only) by means of a power-point presentation on oral health care and hygiene practices. The anganwadi workers of Project-2 (n=98) were provided with oral health training package-2 ( knowledge plus skills) by means practical on the spot demonstration for detection of dental morbidity, brushing and flossing techniques and disclosing dental plaque. The anganwadi workers of intervention groups were distributed a story on oral hygiene. They were told to recite the story to children in their anganwadi centres every day. A poster was also designed with pictorial presentation of dental plaque, dental caries, nursing bottle caries and cariogenic food for putting up in their respective anganwadi centres. Their knowledge and skills were also assessed before and after imparting training. These were then made responsible to impart oral health education to the parents and children during their day to day activities. After 2 months the AWC were visited again for reexamination of children for dental morbidity. The mothers were also interviewed similar to pre-intervention visit regarding change in oral habits of their children. Saliva was also collected in tubes to detect caries susceptibility.
Prevalence of caries in children aged 3-6 years in anganwadis of Chandigarh was found to be 48.3%.It was highest in the age group of 5-6 years (63.2%) and in males (51.2%).The prevalence was highest in urban area (48.3%) and in lower socio-economic group (77.7%). There were no cases of filled teeth in any of the children examined. Out of the total teeth examined for caries, mandibular second molar was most affected. Mean dmft (decayed, missing, filled teeth) score in the population was 2.1± 3.20. The knowledge of anganwadi workers increased significantly post-intervention about brushing habits (reason, duration, frequency of brushing; type of toothbrush, when to change toothbrush), use of toothpaste (amount of toothpaste, level of fluoride required), mouth rinsing habit, primary and secondary dentition, gingival hygiene and flossing. The overall knowledge score of AWWs in both the projects increased significantly after the intervention, but the increase in score was more in Project-2 as compared to Project-1. AWW of project-2 demonstrated better skills in brushing and flossing techniques as compared to project-1 after their respective training.
There was significant increase in brushing habits (twice or more daily) from 4.2% to 9.9%, and rinsing of mouth after meals from 39.5% to 52.2% post-intervention. Caries activity (Snyder test) among children decreased from 48.2% pre-intervention to 31.2% post- intervention. It is therefore justified to say that imparting knowledge and skills to anganwadi workers brings about a desired change in the oral habits and dental morbidity among preschool children.
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