| CTRI Number |
CTRI/2025/11/096961 [Registered on: 06/11/2025] Trial Registered Prospectively |
| Last Modified On: |
05/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to find how much silver is going into body of young children after applying SDF (Silver diamine fluoride), which is a liquid applied on teeth to stop cavities from spreading. |
|
Scientific Title of Study
|
Plasma and Salivary Assessment for Silver Levels Post-Silver Diamine Fluoride (SDF) Application in Children Aged 2-6 Years: A Prospective Cohort Study |
| Trial Acronym |
SDF (Silver Diamine Fluoride) |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sadia Iqbal |
| Designation |
Junior Resident |
| Affiliation |
PGIMER |
| Address |
Room 202 Unit of Pedodontics and Preventive Dentistry
Oral Health Sciences Centre PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9818054483 |
| Fax |
|
| Email |
iqbalsadia07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manojkumar Jaiswal |
| Designation |
Additional Professor |
| Affiliation |
PGIMER |
| Address |
Room 202 Unit of Pedodontics and Preventive Dentistry
Oral Health Sciences Centre PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7888206664 |
| Fax |
|
| Email |
drmanojjaiswal@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manojkumar Jaiswal |
| Designation |
Additional Professor |
| Affiliation |
PGIMER |
| Address |
Room 202 Unit of Pedodontics and Preventive Dentistry
Oral Health Sciences Centre PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7888206664 |
| Fax |
|
| Email |
drmanojjaiswal@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Room 202 Unit of Pedodontics and Preventive Dentistry
Oral Health Sciences Centre
PGIMER |
|
|
Primary Sponsor
|
| Name |
Unit of Pedodontics and Preventive dentistry Oral Health Sciences Centre PGIMER |
| Address |
Oral Health Sciences Centre PGIMER Chandigarh 160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sadia Iqbal |
Unit of Pedodontics and Preventive Dentistry |
Room 202, 2nd floor, Oral Health Sciences Centre, PGIMER
Chandigarh
CHANDIGARH |
9818054483
iqbalsadia07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Intramural |
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 |
38 percent Silver Diamine Fluoride |
38 percent Silver Diamine Fluoride will be applied to carious teeth. 2ml of Blood and saliva samples will be collected at baseline 4 hours and 1 month to assess silver levels and sent to laboratory same day for silver ions concentration analysis. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Children reporting to the Unit of Pedodontics and Preventive Dentistry Oral Health Sciences Centre to receive dental treatment
Multiple carious teeth requiring SDF application
Parental consent obtained to be part of the study
|
|
| ExclusionCriteria |
| Details |
Presence of any known systemic diseases or syndromic cases
Patients with a history of allergic reactions to silver or products
History of any fluoride treatment in the past 3 months
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the levels of silver in plasma serum and saliva at baseline before SDF application at 4 hours and 1 month of SDF application using Inductively coupled plasma mass spectrometry ICPMS |
Baseline before SDF application
4 hours after SDF application
1 month after SDF application |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate arrest of caries post-SDF application using ICDAS-II Criteria and to assess any localized adverse effect of SDF application |
Baseline before SDF application
4 hours after SDF application
1 month after SDF application |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 4 |
|
Date of First Enrollment (India)
|
26/11/2025 |
| 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="0"
Months="1"
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
|
A prospective cohort study to evaluate silver levels in plasma and saliva of children aged 2 to 6 years following application of 38 percent Silver Diamine Fluoride SDF on carious teeth and blood and saliva samples will be collected at baseline 4 hours of application and 1 month post SDF application to assess pharmacokinetic changes of silver ions |