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CTRI Number  CTRI/2025/09/093999 [Registered on: 01/09/2025] Trial Registered Prospectively
Last Modified On: 29/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluation of Streptococcus mutans post Silver Diamine Fluoride treatment. 
Scientific Title of Study   Comparative evaluation of salivary Streptococcus mutans count after Silver Diamine Fluoride treatment with Glass Ionomer Cement versus Stainless Steel Crown -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 Manisha 
Designation  Post Graduate Student 
Affiliation  MAIDS, NEW DELHI 
Address  5th floor, Department of Pediatric and Preventive Dentistry, Maulana Azad Institute of Dental Sciences, BSZ Marg

Central
DELHI
110002
India 
Phone  8168000175  
Fax    
Email  manisha290697@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mridula Goswami 
Designation  Professor(SAG) and Head of Department, Maulana Azad Institute of Dental Sciences 
Affiliation  MAIDS, NEW DELHI 
Address  Department of Pediatric and Preventive Dentistry, Maulana Azad Institute of Dental Sciences, BSZ Marg

Central
DELHI
110002
India 
Phone  9654700977  
Fax    
Email  mm_goswami@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Manisha 
Designation  Post Graduate Student 
Affiliation  MAIDS, NEW DELHI 
Address  5th floor, Department of Pediatric and Preventive Dentistry, Maulana Azad Institute of Dental Sciences, BSZ Marg

Central
DELHI
110002
India 
Phone  8168000175  
Fax    
Email  manisha290697@gmail.com  
 
Source of Monetary or Material Support  
Department of Pediatric and Preventive Dentistry, Maulana Azad Institute of Dental Sciences,BSZ Marg, New Delhi, Delhi, India, 110002 
 
Primary Sponsor  
Name  none 
Address  none 
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 Manisha  Maulana Azad Institute of Dental Sciences  5th floor, Department of Pediatric and Preventive Dentistry, Maulana Azad Institute of Dental Sciences, BSZ Marg, New Delhi. Central DELHI
New Delhi
DELHI 		 08168000175

manisha290697@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Maulana Azad Institute of Dental Sciences  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  NIL  NIL 
Intervention  SDF application followed by Glass Ionomer Cement  Salivary Streptococcus mutans count in saliva is measured after SDF application followed by Glass Ionomer Cement restoration in Group 1 at baseline, 24 hours, 72 hours and 1 month post intervention 
Intervention  SDF application followed by Stainless Steel Crown  Salivary Streptococcus mutans count is measured before and after SDF application followed by Stainless Steel Crown in Group 2 at 24 hours, 72 hours and 1 month post intervention  
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  1. Cooperative children in the age group of 4-8 years.
2. Children with carious primary molar with ICDAS II score 4, 5 and 6, without involving pulp, indicated for SDF and SSC.
 
 
ExclusionCriteria 
Details  1. Clinical and radiographic signs of periapical pathology.
2. Children with any Special Health Care Needs or any systemic disease.
3. Children with any dental developmental anomalies or tooth fracture.
4. Children with silver and nickel allergy.
5. Primary molar close to exfoliation (more than 2/3rd root resorption).
6. Children who have received antibiotics two week prior to microbial sampling.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Any change in salivary Streptococcus mutans count after restoration with Glass Ionomer Cement or Stainless Steel Crown in SDF treated primary molars is expected  At baseline, 24 hours, 72 hours and 1 month post intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="22"
Sample Size from India="22" 
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 
Date of First Enrollment (India)   09/09/2025 
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="0"
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  

This study is a randomized, single-blinded, single-centre trial comparing the salivary Streptococcus mutans count after Silver Diamine Fluoride treatment with Glass Ionomer Cement versus Stainless Steel Crown  in 22 children aged 4–8 years, presenting to the Outpatient Department of Pediatric and Preventive Dentistry, MAIDS, New Delhi. Participants will be randomly allocated into two equal groups (n=11) using a single-blinded, simple randomization technique via lottery method. Group 1 will receive SDF application followed by GIC restoration, while Group 2 will receive SDF application followed by SSC restoration. saliva samples will be collected using the drooling technique before, 24 hours, 72 hours and one month post intervention. The need for this study arises from the lack of studies that evaluated the effect of SDF in conjunction with different restorations on S. mutans level in saliva which can provide valuable insights into improving preventive and restorative dental care using SDF.

 
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