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CTRI Number  CTRI/2021/10/037395 [Registered on: 20/10/2021] Trial Registered Prospectively
Last Modified On:
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Preventing the spread of tooth decay in preschool children by applying various fluoride varnishes  
Scientific Title of Study   EFFECTIVENESS OF VARIOUS FLUORIDE VARNISHES IN ARRESTING CAVITATED DENTINAL LESION IN PRESCHOOL CHILDREN - A CLINICAL TRAIL 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mounashree N 
Designation  Post graduate student  
Affiliation  Rajarajeswari Dental College and Hospital 
Address  Department of Pediatric and Preventive Dentistry No.14, Ramohalli cross, Mysore road, kumbalgodu, Bengaluru.

Bangalore
KARNATAKA
560074
India 
Phone  7019662344  
Fax    
Email  mounagowda88@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mounashree N 
Designation  Post graduate student  
Affiliation  Rajarajeswari Dental College and Hospital 
Address  Department of Pediatric and Preventive Dentistry No.14, Ramohalli cross, Mysore road, kumbalgodu, Bengaluru.

Bangalore
KARNATAKA
560074
India 
Phone  7019662344  
Fax    
Email  mounagowda88@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mounashree N 
Designation  Post graduate student  
Affiliation  Rajarajeswari Dental College and Hospital 
Address  Department of Pediatric and Preventive Dentistry No.14, Ramohalli cross, Mysore road, kumbalgodu, Bengaluru.

Bangalore
KARNATAKA
560074
India 
Phone  7019662344  
Fax    
Email  mounagowda88@gmail.com  
 
Source of Monetary or Material Support  
Rajarajeswari Dental College and Hospital  
 
Primary Sponsor  
Name  Dr Mounashree N 
Address  Department of Pediatric and Preventive Dentistry No.14, Ramohalli cross, Mysore Road, Kumbalgodu, Bengaluru. 
Type of Sponsor  Other [Self funded] 
 
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 Nagarathna C  Rajarajeswari Dental College and Hospital  Department of Pediatric and Preventive Dentistry, No.14 Ramohalli cross, Kumbalgodu Bengaluru, 560074
Bangalore
KARNATAKA 		 9845581779

shaanrathna@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Rajarajeswari Dental College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  38% Silver diamine fluoride   Initial cleaning of cavity was performed by using small cotton pellet under good isolation. Silver diamine fluoride 38% solution were dispensed into a mixing well, then applied directly on to the primary teeth dentin using a disposable micro applicator tip and it was allowed to absorb for up to 1min. Oral hygiene instructions given and parents are instructed that the child should not drink water or eat food for 45min after application.  
Comparator Agent  Bifluorid 10 varnish   Initial cleaning of cavity was performed by using small cotton pellet under good isolation. Bifluorid10 varnish were dispensed into a mixing well, then applied directly on to the primary teeth dentin using a disposable micro applicator tip for and it was allowed to absorb for up to 2mins. Oral hygiene instructions given and parents are instructed that the child should not drink water or eat food for atleast 45mins after application  
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  5.00 Year(s)
Gender  Both 
Details  •Children aged between 3-5 years from either gender.
•Dental Caries with active dentinal carious lesion in children.
•Parents giving consent for the study.
•At least 1 carious lesion as defined by the International Caries Detection and Assessment System (ICDAS). Using ICDAS, lesions were categorized as active (soft) cavitated carious lesions in the primary dentition, extending into the dentin (ICDAS 5 or 6)
 
 
ExclusionCriteria 
Details  •Children who received fluoride topical application during last 48 hours.
•Children with special health care needs.
•Tooth with an abscess, symptoms of irreversible pulpitis, or a mobile tooth.
•Children who were on antibiotic therapy within past 3 months.
•Children with known sensitivity to silver or other heavy-metal ion were excluded.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Decrease in caries activity  1week 
 
Secondary Outcome  
Outcome  TimePoints 
Arrest of Caries lesion  1week 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   20/10/2021 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This is a Randomized Clinical Trail to be done to compare the effectiveness various fluoride varnishes in arresting cavitated dentinal lesions in preschool children with uncooperative behaviour. Twenty dentinal carious lesions of primary teeth selected for 38% SDF application and then Twenty dentinal carious lesions of primary teeth selected for sodium fluoride varnish application(bifluorid10 varnish).Baseline data to collected before fluoride application. Clinical assessment to be done after the fluoride application at 1 week follow up using WHO CPI probe, if carious lesion is soft on probing it indicated active carious lesion, if its hard on probing it indicates caries arrest, and then the data is collected. If the caries activity is present further treatment of caries excavation and restoration is advised. In case of caries arrest cavitated lesion to be restored with glass ionomer cement. 
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