| CTRI Number |
CTRI/2024/03/063982 [Registered on: 12/03/2024] Trial Registered Prospectively |
| Last Modified On: |
30/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To know the effect of placing Silver Diamine fluoride (a caries arresting agent) either alone or in combination with potassium iodide solution on the retention of composite resin filling material used for restoring cavitated primary molars in clinical setting. |
|
Scientific Title of Study
|
Effect of Application of Silver Diamine Fluoride (SDF) Alone Compared to SDF with Potassium Iodide on Retention of Composite Resin Restorations in Carious Primary Molars- A Randomized Clinical 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 Amna Afrin Kidwai |
| Designation |
Junior Resident (MDS) |
| Affiliation |
AIIMS, New Delhi |
| Address |
6th floor, Center of Dental Education and Research,AIIMS, New Delhi
New Delhi DELHI 110029 India |
| Phone |
8800637254 |
| Fax |
|
| Email |
amnakidwai97@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Kalpana Bansal |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences New Delhi |
| 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 Amna Afrin Kidwai |
| Designation |
Junior Resident (MDS) |
| Affiliation |
AIl India Institute of Medical Sciences, New Delhi n |
| Address |
6th Floor, Center of Dental Education and Research, AIIMS, New Delhi
New Delhi DELHI 110025 India |
| Phone |
8800637254 |
| Fax |
|
| Email |
amnakidwai97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of preventive and pediatric dentistry , CDER, AIIMS, New Delhi |
|
|
Primary Sponsor
|
| Name |
Dr Amna Afrin Kidwai |
| Address |
Department of Pediatric and Preventive Dentistry, All India Institute of Medical Sciences, Ansari Nagar East, 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 Amna Afrin Kidwai |
AIIMS, New Delhi. |
Room Number 604, 6th floor, Department of Pediatric and Preventive Dentistry, Center of Dental Education & Research New Delhi DELHI |
8800637254
amnakidwai97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for post graduate research, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K025||Dental caries on pit and fissure surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Composite Resin Restoration |
Composite resin restoration to be done as usual restorative technique. |
| Intervention |
Silver Diamine Fluoride and Potassium Iodide with Composite Resin Restoration |
Addition of potassium iodide prevents the discoloration caused by Silver Diamine Fluoride. This procedure will take 5-6 minutes. |
| Intervention |
Silver Diamine Fluoride with Composite Resin Restoration |
It is a caries preventive agent that is applied on to the carious tooth surface beneath restoration to arrest caries progression. This procedure will take 4-5 minutes. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1. Sytemically healthy children in the age group of 4-9 years.
2. Children with Frankl behavior rating scale of positive or definitely positive
3. Asymptomatic dentinal cavitated lesions on occlusal or proximal surface in atleast one primary molars.
|
|
| ExclusionCriteria |
| Details |
1. Teeth with signs of pulpal and periapical pathology
2. Teeth with physiological mobility due to root resorption
3. Teeth with developmental defect and hypoplasia
4. Teeth having deep carious lesions with close proximity to pulp
5. 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 evaluate and compare the effect of Silver Diamine fluoride alone and Silver diamine fluoride with Potassium iodide on the retention of composite resin restoration in primary molars. |
At 6 months and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of Silver Diamine Fluoride with and without Potassium Iodide on arrest of secondary caries. |
at 6 months and 12 months |
| To assess the discoloration on the composite resin restoration after application of Silver diamine fluoride with and without potassium iodide. |
at 6 months and 12 months. |
|
|
Target Sample Size
|
Total Sample Size="150" Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="150" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
21/03/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="9" Days="0" |
|
Recruitment Status of Trial (Global)
|
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
Modification(s)
|
| Recently, the use of silver modified atraumatic restorative treatment (SMART) has proved to be an effective restoration strategy for carious teeth in pediatric dentistry. This technique involves an application of Silver Diamine Fluoride (SDF) after caries excavation and restoration with a Glass Ionomer Cement (GIC). Though effective, it is not a durable option in “load bearing" molar teeth where the predominant functions are biting and chewing. The composite restorations have largely replaced GIC as the material of choice in permanent teeth. Hence, it may also be assumed that they can be a better alternative to GIC in SMART in primary molars in clinical settings. Further, composite resin is more workable and allows the operator to adapt, shape, and finish the restoration closer to its original form and function. A roadblock in complete replacement of GIC by composite in SMART is due to the micromechanical bonding of the latter to enamel and dentin which can be a concern when the carious dentin has been treated with SDF application. The inherent disadvantage of SDF is also due to its discoloration of teeth and margins of an esthetic restorative material. Several researchers have tried to counter this by applying a super saturated solution of potassium iodide to reduce the dark color of the dentin. This has been efficacious but can alter the properties of the dentin and bonding potential of the restorative materials. Several in vitro studies have evaluated the effect of SDF on the bond strength of composite restorations and showed conflicting evidence. To the best of our knowledge, no clinical study has evaluated this aspect. Hence, this study has been planned to evaluate the retention of composite resin-restoration in carious primary molars after application of SDF alone and with Potassium iodide after caries excavation, in a randomised controlled trial setting. | |