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CTRI Number  CTRI/2024/03/063408 [Registered on: 01/03/2024] Trial Registered Prospectively
Last Modified On: 29/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry
Other (Specify) [Restorative dentistry]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Caries control using Nano Silver Fluoride application in children 
Scientific Title of Study   NANO SILVER FLUORIDE USED IN CARIES ARREST EVALUATED WITH AND WITHOUT RESTORATION IN CHILDREN - A PROSPECTIVE STUDY 
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 Berin Dhanya N B 
Designation  Post Graduate Student  
Affiliation  Rajarajeswari Dental College and Hospital 
Address  Rajarajeswari Dental College and Hospital Department of Pediatric and Preventive Dentistry No.14, Ramohalli Cross, Mysore Road, Kumbalgodu, Bangalore.

Bangalore
KARNATAKA
560074
India 
Phone  8838882975  
Fax    
Email  berindhanya@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nagarathna C  
Designation  Professor  
Affiliation  Rajarajeswari Dental College and Hospital 
Address  Rajarajeswari Dental College and Hospital Department of Pediatric and Preventive Dentistry No.14, Ramohalli Cross, Mysore Road, Kumbalgodu, Bangalore.

Bangalore
KARNATAKA
560074
India 
Phone  9845581779  
Fax    
Email  shaanrathna@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nagarathna C  
Designation  Professor  
Affiliation  Rajarajeswari Dental College and Hospital 
Address  Rajarajeswari Dental College and Hospital Department of Pediatric and Preventive Dentistry No.14, Ramohalli Cross, Mysore Road, Kumbalgodu, Bangalore.

Bangalore
KARNATAKA
560074
India 
Phone  9845581779  
Fax    
Email  shaanrathna@gmail.com  
 
Source of Monetary or Material Support  
Rajarajeswari Dental College and Hospital, No. 14 Ramohalli Cross, Mysore Road, Kumbalgodu, Karnataka, 560074 
 
Primary Sponsor  
Name  Dr Berin Dhanya N B  
Address  Rajarajeswari Dental College and Hospital, Department of Pediatric and Preventive Dentistry No.14, Ramohalli Cross, Mysore Road, Kumbalgodu, Bengaluru, Karnataka 560074. 
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 Berin Dhanya N B   Rajarajeswari Dental College and Hospital  Department of Pediatric and Preventive Dentistry No.14, Ramohalli Cross, Mysore Road,Kumabalgodu, Karnataka
Bangalore
KARNATAKA 
8838882975

berindhanya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee of 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 
Comparator Agent  Nano Silver Fluoride (single time topical application) without restoration  Recording dmfs index prior to the application of Nano Silver Fluoride without restoration and recording the dmfs index after 6 months 
Intervention  Nano Silver Fluoride (single time topical application), followed by restoration   Recording dmfs index prior to the application of Nano silver fluoride, followed by GIC restoration and recording the dmfs index after 6 months  
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  1. Children of 3-6 years of age from either gender.
2. Atleast one tooth with soft cavitated dentine surfaces received scores 5 (Distinct cavitation with visible dentin, involving less than half of a tooth surface) of the ICDAS criteria.
 
 
ExclusionCriteria 
Details  1. Children who received topical fluoride application during the last 3 months
2. children with special health care needs
3. Tooth with symptoms of irreversible pulpitis
4. Children with known sensitivity to silver or other heavy metal ion
5. Hypoplastic or developmental defects 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine and compare the caries incidence across study arms over time   Baseline and 6 months after the intervention 
 
Secondary Outcome  
Outcome  TimePoints 
To determine and compare the caries pattern across study arms over time   Baseline and 6 months after the intervention 
 
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/ Phase 3 
Date of First Enrollment (India)   12/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  12/02/2024 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   This is a prospective study to determine the compare the caries incidence and caries pattern with and without restoration after the application of Nano silver fluoride(NSF). 

An aseptic protocol will be carried out throughout the procedure. Clinical examination of children will be performed using plain mirror and explorer on the dental chair with optimal light. Activity of cavitated dentinal caries lesion will be assessed by visual inspection and aided by tactile detection using an explorer. Each child will be examined for carious status using International Caries Detection and Assessment System (ICDAS).

After clinical examination, subjects fulfilling the selection criteria will be randomly divided into two groups, Group A (n=20) Group B (n=20). NSF application will be carried out in both groups & GIC restoration of treated occlusal lesions in group B, dietary and oral hygiene instructions will be given to all children.

NSF application procedure is as follows:

All the study participants will be subjected to thorough oral prophylaxis, no effort would be done to remove the caries or unsupported enamel followed by cotton roll isolation and  initial cleaning of the cavity to be performed by using small cotton pellet, tooth with active caries lesion will receive two drops of NSF with an applicator tip and the same tip is applied across all the tooth surfaces & discarded after single use. Application time is 2 minutes. Excess NSF is to be removed with cotton pellet to minimize systemic ingestion.

Clinical examination of all the subject subjects will be done over a period of 6 months to ascertain any change in the dmfs index, caries pattern, retention of GIC cement, any adverse events.

 
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