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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   
Secondary IDs if Any  
Secondary ID  Identifier 
Micro/2011/5961 dated 4/3/2011  Protocol Number 
 
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  
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 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  
Status 
Not Applicable 
 
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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