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CTRI Number  CTRI/2024/04/066461 [Registered on: 29/04/2024] Trial Registered Prospectively
Last Modified On: 26/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effectiveness of fluoride varnish in prevention of dental caries in rural school children 
Scientific Title of Study   Dental caries status and effectiveness of fluoride varnish in caries prevention in school children of Rural area of Namkum , Ranchi: Randomised control trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Swati Sharma 
Designation  Associate Professor 
Affiliation  Dental Institute, Rajendra institute of Medical Sciences, Ranchi 
Address  Dept. of Pedodontics & Preventive Dentistry, Dental Institute, Rajendra institute of Medical Sciences, Ranchi

Ranchi
JHARKHAND
834009
India 
Phone  7562048287  
Fax    
Email  drswati.sharma8@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Swati Sharma 
Designation  Associate Professor 
Affiliation  Dental Institute, Rajendra Institute Of Medical Sciences, Ranchi 
Address  Dept. of Pedodontics & Preventive Dentistry, Dental Institute, Rajendra Institute Of Medical Sciences, Ranchi

Ranchi
JHARKHAND
834009
India 
Phone  7562048287  
Fax    
Email  drswati.sharma8@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Swati Sharma 
Designation  Associate Professor 
Affiliation  Dental Institute, Rajendra Institute Of Medical Sciences, Ranchi 
Address  Dept. of Pedodontics & Preventive Dentistry, Dental Institute, Rajendra Institute Of Medical Sciences, Ranchi

Ranchi
JHARKHAND
834009
India 
Phone  7562048287  
Fax    
Email  drswati.sharma8@gmail.com  
 
Source of Monetary or Material Support  
Model Rural Health Research Unit, Academic Building, Institute of Public Health, Namkum, Ranchi, Jharkhand, India, P.O.- 834010 
 
Primary Sponsor  
Name  Model Rural Health Research Unit 
Address  Academic Building, Institute of Public Health, Namkum, Ranchi, Jharkhand, India, P.O.- 834010 
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 Swati Sharma  Dental Institute, Rajendra Institute of Medical Sciences  Dept. of Pedodontics and Preventive Dentistry, Room No. 3, 1st Floor
Ranchi
JHARKHAND 
7562048287

drswati.sharma8@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICS COMMITTEE,RIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Dental Caries 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Drug:Fluoride varnish 22600 ppm  Topical application on erupted first permanent molar every 6 months for a total period of 2 years and oral hygiene instructions. other name - Voco Profluorid varnish 
Comparator Agent  Oral hygiene instructions  No intervention 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  7.00 Year(s)
Gender  Both 
Details  1. Healthy child 6–7 years old with no acute or chronic systematic disorders.
2. Presence of partially or completely erupted first permanent molar. 
 
ExclusionCriteria 
Details  1. Children without signed consent
2. Children under any type of medication, or asthmatic or allergic history.
3. Children with hypoplastic defects, fluorosis or pit & fissure sealed first molars
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduced incidence of caries in varnish group is expected as compared to non-varnish group
 
6,12,18,24 months
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Improved oral hygiene behaviour.
2. Reduced incidence of loss of teeth due to caries. 
6,12,18,24 months 
 
Target Sample Size   Total Sample Size="600"
Sample Size from India="600" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

INTRODUCTION
Dental caries is one of the most common microbiological infectious diseases found in children and even adults worldwide. The World Health Organization (WHO) estimated that 60% to 90% of all children of school age have experienced dental caries.1 Changing diet pattern of refined carbohydrates and improper oral hygiene practice are the main culprits. Fluorides play a central role in the prevention of dental caries and are also used therapeutically for the inactivation of incipient carious lesions. The effect of fluoride is mainly achieved when applied topically, which is further enhanced when accompanied by good oral hygiene.2 Fluoride varnish application twice a year reduces the incidence of caries by 37% in primary teeth and 43% in permanent teeth.3 Topical fluorides increase the availability of fluoride ions in saliva and enhance the formation of fluorapatite. Fluorapatite is strongly resistant to acid attacks and demineralization. Varnish is a professional topically applied fluoride system. Varnish has been used extensively as a caries prevention strategy for over 3 decades. Despite their high concentration of fluoride, fluoride varnishes are considered safe. This may be due to the fast setting of the varnish, which reduces the amount of ingested fluoride. 4,5

 Namkum CD block is located on the Ranchi plateau. Namkum CD block had a total population of 145,841 out of which about 60% are tribal and out of the total population, 118,002 were rural and 27,839 were urban. There are 92 inhabited villages in Namkum CD block. Namkum CD block had 11 villages with pre-primary schools, 77 villages with primary schools, 35 villages with middle schools, 11 villages with secondary schools. 6

The tribal population Namkum CD block usually have low literacy rate and they follow their traditional custom for health treatment. Besides the facilities of dental health services are poor in rural and tribal location.

 NEED FOR STUDY

This research will help in prevention of dental caries as soon as the permanent tooth start erupting and guide children of rural area about importance of proper brushing and diet which can be implemented by the community department for further implementing this model for all the schools.

 
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