| CTRI Number |
CTRI/2025/02/079990 [Registered on: 06/02/2025] Trial Registered Prospectively |
| Last Modified On: |
06/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of gel formulation of Silver diamine fluoride ( a caries arresting agent ) with conventional solution to stop caries in primary teeth . |
|
Scientific Title of Study
|
Comparative evaluation of caries arrest potential of silver diamine fluoride gel with conventional solution form in primary teeth- A randomized controlled trial. |
| 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 Ligam Padu |
| Designation |
Junior Resident (MDS) |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
6th floor Center of Dental Education and Research AIIMS new Delhi
New Delhi
DELHI
110029
India |
| Phone |
9436081691 |
| Fax |
|
| Email |
ligampadu.lp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kalpana Bansal |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room number 604 6th floor Center of Dental Education and Research AIIMS new Delhi
New Delhi
DELHI
110029
India |
| Phone |
9810105132 |
| Fax |
|
| Email |
drkalpanabansal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ligam Padu |
| Designation |
Junior Resident (MDS) |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
6th floor Center of Dental Education and Research AIIMS new Delhi
New Delhi
DELHI
110029
India |
| Phone |
9436081691 |
| Fax |
|
| Email |
ligampadu.lp@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatric dentistry, CDER, Ansari Nagar, New Delhi, Delhi, India. PIN: 110029 |
|
|
Primary Sponsor
|
| Name |
Dr. Ligam Padu |
| Address |
Department of Pediatric dentistry ,CDER, AIIMS ,New Delhi |
| Type of Sponsor |
Other [self] |
|
|
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 Ligam Padu |
AIIMS New Delhi |
Room Number 604 ,6th floor ,Department of Pediatric and Preventive Dentistry, Center of Dental Education and Research New Delhi
New Delhi
DELHI |
9436081691
ligampadu.lp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee-AIIMS NEW DELHI |
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% Silver diamine Fluoride gel with potassium iodide |
it is a caries preventive agent with a gel forming agent that is applied on to carious tooth under cotton pellets isolation to arrest caries progression. This entire procedure of application of intervention will take about 4-5 minutes. |
| Comparator Agent |
38% Silver Diamine Fluoride solution and potassium iodide |
It is a caries preventive agent that is applied on to carious tooth to arrest caries progression and potassium iodide prevents the discoloration caused by Silver Diamine Fluoride. This procedure will be done under cotton pellets isolation and will take approximately 4-5 minutes |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1-Healthy children from the age of 4-8 years
2-Child having at-least one asymptomatic active cavitated lesion in primary tooth
3-Children whose cooperation level is scored as positive or
definitely positive as per Frankl Behaviour Rating Scale |
|
| ExclusionCriteria |
| Details |
1-Teeth with pain, or any other symptoms suggestive of pulpitis
2-Teeth with signs of irreversible of irreversible pulpitis (spontaneous pain, abscess, pathological mobility)
3-Teeth suggesting signs of non-vital pulp.
4-Children having significant chronic systematic condition or taking long term medication that may affect oral health
5-Children whose parents don’t give consent for the SDF application
6-Children with known allergy to silver |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare and evaluate the caries arrest potential of
novel Silver Diamine Fluoride gel and Conventional SDF
solution in cavitated carious lesions in primary teeth |
Baseline, 1 month, 6 month, 12 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1-To compare the taste acceptability of the patient
2-Parental acceptance level |
Taste acceptability will be assessed at the baseline at the time of application of the SDF sol or gel.
Parent acceptance level will be assessed at 6 month follow up visit |
|
|
Target Sample Size
|
Total Sample Size="252"
Sample Size from India="252"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
18/02/2025 |
| 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="1"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Thirty-eight percent silver diamine fluoride (SDF) has been found to arrest carious lesions, but multiple applications are more effective than a single treatment. Although safe, the liquid form of SDF is difficult to control in young children, increasing the possibility of inadvertent exposure of the soft tissues. Moreover, SDF solution is bitter and has a metallic taste, and children who have many teeth to be treated may respond negatively to the taste. A gel version of 38% SDF became available in the United States in early 2023 and in 2022 in India. A few in vitro studies using SDF gel have been reported in the literature. SDF gel has been shown to exhibit less cytotoxic effect compared to Kidz-e and Fagamin and can be considered the best choice for arresting caries in primary and permanent teeth. To date, the clinical studies on dental caries arrest potential of SDF gel are limited. Also, the clinical/in-vivo studies comparing the caries arrest potential of novel silver diamine fluoride gel with conventional solution in primary teeth are scarce. Hence, this study is planned to compare caries arrest potential between the SDF gel and the solution form on the dentinal lesions in primary teeth in children |