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CTRI Number  CTRI/2024/04/066524 [Registered on: 30/04/2024] Trial Registered Prospectively
Last Modified On: 10/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   Evaluation and comparision of s-IgA in children with and without recurrent respiratory infections before and after application of nanosilver fluoride on carious teeth 
Scientific Title of Study   EVALUATION AND COMPARISION OF s-IgA LEVELS BEFORE AND AFTER NANO SILVER FLUORIDE APPLICATION ON CARIOUS PRIMARY TEETH IN CHILDREN WITH & WITHOUT RECURRENT RESPIRATORY INFECTIONS - AN INVIVO 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 K. Swetha 
Designation  POST GRADUATE STUDENT 
Affiliation  RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL 
Address  DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL, NO. 14, RAMOHALLI CROSS, MYSORE ROAD, BENGALURU.
Rajarajeshwari dental college and hospital
Bangalore
KARNATAKA
560074
India 
Phone  08008587368  
Fax    
Email  saiswethasankar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jaya A R 
Designation  Professor 
Affiliation  RAJARAJESHWARI DENTAL COLLEGE AND HOSPITAL 
Address  DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL, NO. 14, RAMOHALLI CROSS, MYSORE ROAD, BENGALURU.

Bangalore
KARNATAKA
560074
India 
Phone  9880038038  
Fax    
Email  jaya.vrushabh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jaya A R 
Designation  Professor 
Affiliation  RAJARAJESHWARI DENTAL COLLEGE AND HOSPITAL 
Address  DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL, NO. 14, RAMOHALLI CROSS, MYSORE ROAD, BENGALURU.

Bangalore
KARNATAKA
560074
India 
Phone  9880038038  
Fax    
Email  jaya.vrushabh@gmail.com  
 
Source of Monetary or Material Support  
Rajarajeswari Dental College and Hospital, No. 14, Ramohalli Cross, Mysore Road, Bengaluru,karnataka, India, 560074 
 
Primary Sponsor  
Name  K.SWETHA  
Address  DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL, NO. 14, RAMOHALLI CROSS, MYSORE ROAD, 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 K Swetha  Rajarajeswari dental college  Room no: 05, Department of paediatric and preventive dentistry
Bangalore
KARNATAKA 
08008587368

saiswethasankar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Rajarajeswari Dental College  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  Nanosilver fluoride  5% Nanosilver fluoride applied topically on primary carious teeth. 
Comparator Agent  s-IgA levels   Evaluation and comparision of s-IgA before and after application of Nanosilver fluoride on 14th day between healthy and children with recurrent respiratory infections  
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  Healthy Children with dental caries.
Children with recurrent respiratory infections and dental caries

 
 
ExclusionCriteria 
Details  Children who recieved topical fluoride in last 1 month.
Children with special health care needs
Pulpally involved and grossly decayed teeth 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Evaluate salivary s-IgA levels before and after application of Nanosilver fluoride using ELISA  Baseline
14 th day 
 
Secondary Outcome  
Outcome  TimePoints 
Evaluation and comparision of
s-IgA levels before and after application of Nanosilver fluoride application on carious primary teeth in children with and wuthout recurrent respiratory infections  
Baseline
14th day 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "25"
Final Enrollment numbers achieved (India)="25" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   15/05/2024 
Date of Study Completion (India) 20/05/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 20/05/2025 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

Recurrent respiratory infections are one of the commonly seen clinical conditions in children. Studies shows that immunity of these children is less compared to healthy children and is said to further reduce as they are subjected to chronic medication such as steroids and antibiotics. s-IgA  plays a major role in first line of host defense against pathogenic microorganisms by inhibiting bacterial adhesion to teeth surfaces, counteracting enzymes like glucoyltransferase, toxins released by streptococcus mutans. Nanosilver fluoride has shown to succesfully arrest caries progression without staining teeth. To our knowledge no studies in literature reported the effect of remineralising agents on s-IgA Levels. Hence the aim of the study is to evaluate and correlate the levels of s-IgA before and after application of Nano silver Fluoride on primary carious teeth in children with and without recurrent respiratory infections.

 


 
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