| 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
|
|
|
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
|
|
|
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.
|