| CTRI Number |
CTRI/2020/11/028914 [Registered on: 05/11/2020] Trial Registered Prospectively |
| Last Modified On: |
27/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Silver diamine fluoride to understand the caries status in children |
|
Scientific Title of Study
|
EFFECT OF SILVER DIAMINE FLUORIDE ON STREPTOCOCCUS MUTANS COLONIZATION IN CHILDREN WITH EARLY CHILDHOOD CARIES – A REAL TIME PCR STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rahul C |
| Designation |
Post Graduate |
| Affiliation |
Rajarajeswari Dental College and Hospital |
| Address |
Department Of Pediatric and Preventive Dentistry
No.14, Ramohalli Cross, Mysore Road, Kumbalgodu,
Bangalore
KARNATAKA
560074
India |
| Phone |
9535383738 |
| Fax |
|
| Email |
nayakrahul444@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rahul C |
| Designation |
Post Graduate |
| Affiliation |
Rajarajeswari Dental College and Hospital |
| Address |
Department Of Pediatric and Preventive Dentistry
No.14, Ramohalli Cross, Mysore Road, Kumbalgodu,
Bangalore
KARNATAKA
560074
India |
| Phone |
9535383738 |
| Fax |
|
| Email |
nayakrahul444@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rahul C |
| Designation |
Post Graduate |
| Affiliation |
Rajarajeswari Dental College and Hospital |
| Address |
Department Of Pediatric and Preventive Dentistry
No.14, Ramohalli Cross, Mysore Road, Kumbalgodu,
Bangalore
KARNATAKA
560074
India |
| Phone |
9535383738 |
| Fax |
|
| Email |
nayakrahul444@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajarajeswari Dental College and Hospital |
|
|
Primary Sponsor
|
| Name |
Dr RAHUL C |
| Address |
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 Nagarathna C |
Rajarajeswari Dental College and Hospital |
Department Of Pediatric and Preventive Dentistry
No.14, Ramohalli Cross, Mysore Road, Kumbalgodu,
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
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Silver diamine fluoride 38% as topical agent |
Base line sample - pre treatment
follow up sample - after 1 day and 1 month
|
| Comparator Agent |
TOPICAL APPLICATION (SINGLE TIME) |
SILVER DIAMINE FLUORIDE 38%
Base line sample - taken during pre treatment
follow up sample - after 1 day and 1 month. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1) Children aged between 3-6 years from either
gender.
2) Early Childhood Caries with active dentinal
carious lesion in children.
3) At least one tooth with soft cavitated dentine surfaces received scores 5 (Distinct cavitation with visible dentin, involving less than half of a tooth surface) or 6 (Extensive cavitation with visible dentin, where the cavity is wide involving more than half of a tooth surface) of the ICDAS criteria. |
|
| ExclusionCriteria |
| Details |
1)Children who received fluoride topical
application during last 48 hours.
2)Children with special health care needs.
3)Tooth with an abscess, symptoms of irreversible pulpitis, or a mobile tooth.
4)Children who were on antibiotic therapy within past 3 months.
5)Children with known sensitivity to silver or other heavy-metal ion were excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Black stains on the SDF applied tooth surface, This hardened surface indicates of arrest of caries |
After one month SDF applied tooth surface is checked for black stains, this hardened surface indicates of arrest of caries |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| EFFECT OF SDF ON INHIBITION OF STREPTOCOCCUS MUTANS COLONIZATION USING REAL TIME PCR STUDY |
1 day and 1 MONTH |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
13/11/2020 |
| 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="2"
Months="1"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is randomized parallel group trial comparing the effect of silver diamine fluoride on streptococcus mutans in saliva sample of children with early childhood caries in 1 month period of time. 30 patients with early childhood caries are taken. Each child will be examined for carious status using international caries detection and assessment system. Teeth which received ICDAS score 5 or 6 are selected. Pre treatment unstimulated saliva samples are taken as follows paper point is dipped in saliva for 30 seconds in the floor of the mouth. Silver diamine fluoride procedure will be carried out as per manufacture instruction, post treatment unstimulated saliva samples will be collected at 24hrs and during follow up at 1 month. All the above samples will be transferred aseptically and sent for microbial analysis. The primary outcome will be change of SDF treated tooth color to black stain which indicates of hardened dentin surface. The secondary outcome will be the effect of SDF on inhibition of streptococcus mutans colonization using real time PCR study |