| 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
|
|
|
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
|
|
|
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. |