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CTRI Number  CTRI/2025/04/084140 [Registered on: 04/04/2025] Trial Registered Prospectively
Last Modified On: 07/02/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study on usefulness of silver diamine fluoride in arresting caries in deciduous teeth of child in age group 3-6 years. 
Scientific Title of Study   Effectiveness of silver diamine fluoride (SDF) in arresting caries in 3-6 years old children - a community based randomised control 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 Ajoy Kumar Shahi 
Designation  Additional Professor 
Affiliation  Rajendra institute of medical sciences 
Address  Department of oral and maxillofacial Surgery, Dental Institute, Rajendra Institute of medical sciences, Bariatu

Ranchi
JHARKHAND
834009
India 
Phone  99553610910  
Fax    
Email  drajoyshahi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ajoy Kumar Shahi 
Designation  Additional Professor 
Affiliation  Rajendra institute of medical sciences 
Address  Department of oral and maxillofacial Surgery, Dental Institute, Rajendra Institute of medical sciences, Bariatu

Ranchi
JHARKHAND
834009
India 
Phone  99553610910  
Fax    
Email  drajoyshahi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ajoy Kumar Shahi 
Designation  Additional Professor 
Affiliation  Rajendra institute of medical sciences 
Address  Department of oral and maxillofacial Surgery, Dental Institute, Rajendra Institute of medical sciences, Bariatu

Ranchi
JHARKHAND
834009
India 
Phone  99553610910  
Fax    
Email  drajoyshahi@gmail.com  
 
Source of Monetary or Material Support  
Model rural health research unit, Community Health Centre, Angara, Ranchi-835103, Jharkhand, India 
 
Primary Sponsor  
Name  Model rural health research unit 
Address  Model rural health research unit, Community Health Centre, Angara, Ranchi-835103, Jharkhand, India 
Type of Sponsor  Government funding agency 
 
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 Ajoy Kumar Shahi  Anganwadi kendras  Anganwadi kendras od Anagara block, Angara, Ranchi
Ranchi
JHARKHAND 
9955361090

drajoyshahi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee, RIMS, Ranchi  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  glass ionomer cement (GIC)  carious tooth treated with glass ionomer cement (GIC) and followed up periodically at interval of 6 months, 12 months, 18 months and 24 months. 
Intervention  silver diamine fluoride (SDF) varnish  carious tooth treated with SDF varnish and followed up periodically at interval of 6 months, 12 months, 18 months and 24 months. 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  At least one soft caries lesion, i.e, cavitated active caries lesion that is small in size (less than half of the mesial or distal or less than one-third of the buccal, lingual, or occlusal surfaces).
 
 
ExclusionCriteria 
Details  Pulpal exposure, history of pain, nonvital teeth, swelling or fistula, silver allergy, arrested caries or inactive lesions, teeth at the period of shedding, restored teeth, secondary caries, fluorosis, enamel hypoplasia, uncooperative behavior, physical or mental disability, and a lack of signed informed consent
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
caries arrest in both experimental and control group  6 months,12 months,18 months,24 months 
 
Secondary Outcome  
Outcome  TimePoints 
complications associated with treatment  6 months,12 months,18 months,24 months 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
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 4 
Date of First Enrollment (India)   01/05/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Rationale-- Traditional treatment approach of drill-and-fill", is associated with pain and fear for small age children. Traditionally, dental caries treatment requires surgical restorative approach, with sophisticated dental equipment and well-trained operators, and is relatively expensive.  SDF offers an alternative innovative treatment option for caries. It is a practical, affordable, and acceptable option for caries treatment, eliminating the need for fear related dental treatment in young children, and can improve long-term oral health outcomes even at community level. 

Novelty- This study is probably the first one to investigate the effectiveness of SDF 38% and GIC in arresting caries of young children of rural area at community level program. Due to the under-developed oral health care system at rural level, most of the decayed teeth in children remain untreated. Untreated dental caries in children can lead to problems with food intake, sleep, daily activities, and self-esteem. Caries arrest treatment with SDF is a non- invasive acceptable and affordable treatment option. Evidence that SDF is comparable in the treatment of dental caries in a school setting may substantially improve the reach and effectiveness of caries prevention as a dental public health intervention 

 
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