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CTRI Number  CTRI/2021/01/030479 [Registered on: 14/01/2021] Trial Registered Prospectively
Last Modified On: 28/12/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Partial caries removal with and without SDF (caries arresting agent) and restoration in children 
Scientific Title of Study   Comparison of success of partial excavation and RMGIC restoration with and without SDF application in primary molars in 3-6-year-old children: A randomized controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Harsh Sachdev 
Designation  Post Graduate Student 
Affiliation  Y.M.T DENTAL COLLEGE AND HOSPITAL 
Address  Room number 21, Second Floor Department of Pediatric and Preventive Dentistry, Y.M.T Dental College and Hospital, Sector 4,Kharghar Navi Mumbai

Raigarh
MAHARASHTRA
410210
India 
Phone  9167720233  
Fax    
Email  harsh.sachdev9@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Amar Katre 
Designation  Professor and Head of the Department 
Affiliation  Y.M.T DENTAL COLLEGE AND HOSPITAL 
Address  Room number 21, Second Floor Department of Pediatric and Preventive Dentistry, Y.M.T Dental College and Hospital, Sector 4,Kharghar Navi Mumbai

Raigarh
MAHARASHTRA
410210
India 
Phone  9821540186  
Fax    
Email  amar_katre@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Harsh Sachdev 
Designation  Post Graduate Student 
Affiliation  Y.M.T DENTAL COLLEGE AND HOSPITAL 
Address  Room number 21, Second Floor Department of Pediatric and Preventive Dentistry, Y.M.T Dental College and Hospital, Sector 4,Kharghar Navi Mumbai

Raigarh
MAHARASHTRA
410210
India 
Phone  9167720233  
Fax    
Email  harsh.sachdev9@gmail.com  
 
Source of Monetary or Material Support  
Monetary support Self-support Dr Harsh Sachdev Infrastructural support Room number 21, Second Floor Department of Pediatric and Preventive Dentistry, Y.M.T Dental College and Hospital, Sector 4,Kharghar Navi Mumbai 
 
Primary Sponsor  
Name  Dr Harsh Sachdev 
Address  Room number 21, Second Floor Department of Pediatric and Preventive Dentistry, Y.M.T Dental College and Hospital, Sector 4,Kharghar Navi Mumbai 
Type of Sponsor  Other [self support] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Amar Katre  Y.M.T dental college and hospital kharghar navi mumbai 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Harsh Sachdev  Y.M.T dental college and hospital  Room number 21, Second Floor Department of Pediatric and Preventive Dentistry, Y.M.T Dental College and Hospital, Sector 4,Kharghar Navi Mumbai
Raigarh
MAHARASHTRA 		 9167720233

harsh.sachdev9@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee YMT dental college and hospital kharghar navi mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Resin modified glass inomer cement (RMGIC)  In the control group the caries from the walls will be excavated using a sharp spoon excavator, leaving the soft dentinal caries on the floor intact. a solution of distilled water will be applied and kept in contact with tooth surface for 3 minutes. Patient will be asked to rinse and a definitive restoration will be done using RMGIC  
Intervention  silver diamine flouride (SDF)  The caries from the walls will be excavated using a sharp spoon excavator, leaving the soft dentinal caries on the floor intact. In the intervention group, a solution of 38% SDF will be applied and kept in contact with tooth surface for 3 minutes. Patient will be asked to rinse and a definitive restoration will be done using RMGIC  
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  1.Primary molars with dentinal caries in otherwise healthy children.
2.Children whose parents give consent for the application of SDF.
 
 
ExclusionCriteria 
Details  1.Tooth with history, clinical or radiographic signs indicative of pulpal and peri-radicular pathology.
2.Children suffering from any systemic condition that may hinder with their participation in the study.
3. Children with known allergy to any material used in the study.
4.Children who cannot co-operate while performing the procedure.
5.Children whose parents refuse to give consent for the study.
 
 
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 
Survival of Restoration and Marginal Integrity of the Restoration.  After the intervention survival of restoration will be checked at 1 month, 6 months, 12 months respectively.
After the intervention Marginal Integrity of restoration will be checked at 1 month, 6 months, 12 months respectively. 
 
Secondary Outcome  
Outcome  TimePoints 
Parents acceptance of application of silver diamine flouride  After application of SDF parents acceptance of black staining for the silver diamine flouride 
 
Target Sample Size   Total Sample Size="222"
Sample Size from India="222" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="107" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   15/01/2021 
Date of Study Completion (India) 10/05/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [harsh.sachdev9@gmail.com].

  6. For how long will this data be available start date provided 01-01-2022 and end date provided 01-01-2027?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  

Silver diamine fluoride (SDF) is widely used for dental caries management in arresting caries and promotes remineralization. Studies have reported a good success rate with partial excavation and restoration with RMGIC. A total of 222 patients will be recruited for the intervention and will be randomly allocated into both the group the intervention group (SDF) and control group.

In both the groups, the caries from the walls will be excavated using a sharp spoon excavator, leaving the soft dentinal caries on the floor intact. In the test group, a solution of 38% SDF will be applied and kept in contact with tooth surface for 3 minutes. In the control group a solution of distilled water will be applied and kept in contact with tooth surface for 3 minutes. Patient will be asked to rinse and a definitive restoration will be done using RMGIC in both the groups. Both groups will be assessed for survival of restoration, marginal integrity and clinical signs of caries progression at 1, 6 and 12 months and radiographic assessment of caries progression at 6 and 12 months. Success rate of intervention will be assessed as survival rate of the restoration (intact or dislodged) and marginal integrity of restoration and will be recorded as a binary categorical variable. Clinical signs of caries progression will be assessed as the presence or absence of pain, swelling, fistula, mobility or abscess and recorded as a binary categorical variable.

 
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