| 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
|
|
|
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
|
|
|
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. |