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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  
Name  Address 
NIL  NIL  
 
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  
Status 
Not Applicable 
 
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.

 
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