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CTRI Number  CTRI/2025/04/084693 [Registered on: 13/04/2025] Trial Registered Prospectively
Last Modified On: 09/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of Two non-drilling Cavity Filling Methods for treatment of Decayed Teeth in children: Cost, long lasting and benefit 
Scientific Title of Study   Comparison of survivability, cost effectiveness, and oral health quality of life of SMART & ART in restoration of primary molars-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 Dharmashree Satyarup 
Designation  Professor and HOD 
Affiliation  Institute of Dental Sciences, Siksha O Anusandhan(deemed to be university), Bhubaneswar 
Address  Department of Public Health Dentistry, Room no.-9, Institute of Dental Sciences, Siksha O Anusandhan(deemed to be university), Bhubaneswar

Khordha
ORISSA
751003
India 
Phone  8008610999  
Fax    
Email  dharmashree_s@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dharmashree Satyarup 
Designation  Professor and HOD 
Affiliation  Institute of Dental Sciences, Soa(deemed to be university), Bhubaneswar 
Address  Department of Public Health Dentistry, Room no.-9, Institute of Dental Sciences, Siksha O Anusandhan(deemed to be university), Bhubaneswar

Khordha
ORISSA
751003
India 
Phone  8008610999  
Fax    
Email  dharmashree_s@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Dharmashree Satyarup 
Designation  Professor and HOD 
Affiliation  Institute of Dental Sciences, Soa(deemed to be university), Bhubaneswar 
Address  Department of Public Health Dentistry, Room no.-9, Institute of Dental Sciences, Siksha O Anusandhan (deemed to be university), Bhubaneswar

Khordha
ORISSA
751003
India 
Phone  8008610999  
Fax    
Email  dharmashree_s@yahoo.com  
 
Source of Monetary or Material Support  
Institute of Dental Sciences, Siksha O Anusandhan(Deemed to be university),Bhubaneswar Pin-751003, Odisha, India 
 
Primary Sponsor  
Name  Silpa Dash 
Address  Department of Public Health Dentistry, Institute of Dental Sciences, SOA university 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Silpa Dash  Institute of Dental Sciences, Siksha O Anusandhan (deemed to be university)  Department of Public Health Dentistry, Room no.-9, Institute of Dental Sciences, Siksha O Anusandhan (deemed to be university), Bhubaneswar, Pin-751003
Khordha
ORISSA 		 7978202172

silpadash98@gmail.com 
Dr Dharmashree Satyarup  Institute of Dental Sciences, Siksha O Anusandhan (deemed to be university)  Department of Public Health Dentistry, Room no.-9, Institute of Dental Sciences, Siksha O Anusandhan (deemed to be university), Bhubaneswar, Pin-751003
Khordha
ORISSA 		 8008610999

dharmashree_s@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC- 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  Atraumatic Restorative Treatment(ART)   Carious dentin removed by using spoon excavator (ART). The prepared cavity is conditioned using dentin conditioner which is usually 10% solution of polyacrylic acid. Mixing of glass ionomer and restoration Excess glass-ionomer material (GIC) will be displaced by using press-finger technique towards the slopes of cusps using petroleum jelly Excess GIC will be removed & parents will be instructed to prohibit the child not eat or drink till one hour.  
Intervention  Silver Modified Atraumatic Restoration Treatment(SMART)  Isolate the tooth by using cotton rolls. Petroleum jelly will be applied to the adjacent teeth and mucosa. Followed by 38% of SDF. Silver Diamine Fluoride (SDF) is a topical dental solution composed of Silver and high concentration of fluoride that is used to prevent and arrest tooth decay. The SDF will be applied directly to the lesion with micro-brush and is left 2 minutes and cleaned with cotton pellet. Lesion on treated tooth will be restored with Glass Ionomer Cement and excess will be removed. Parents will be instructed to prohibit the child not eat or drink till one hour.  
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  11.00 Year(s)
Gender  Both 
Details  Children with at least one carious lesion as defined by the Nyvad’s caries criteria 3 without pulp involvement for caries lesion activity and severity assessment.
Children with informed consent from parents.
 
 
ExclusionCriteria 
Details  Children younger than 6 years and older than 11 years.
Children whose parents denied consent.
Uncooperative children.
Medically compromised patients
Children with spontaneous or elicited pain from caries, tooth mobility or signs of pulpal infections
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Survival rates: compare the effectiveness of Silver Modified Atraumatic Restorative Treatment and Atraumatic Restorative Treatment in treatment of dental caries in a school setting.
Cost-effectiveness: assess the cost effectiveness of Silver Modified Atraumatic Restorative Treatment and Atraumatic Restorative Treatment restorations in primary molars.
 
9 months
 
 
Secondary Outcome  
Outcome  TimePoints 
Time duration of procedure
Oral Health Quality of Life 		 During procedure
Baseline and 9 months  
 
Target Sample Size   Total Sample Size="130"
Sample Size from India="130" 
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   N/A 
Date of First Enrollment (India)   02/06/2025 
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   The  title of the study "Comparison of Survival, Cost Effectiveness, and Oral Health Quality of Life of Silver Modified Atraumatic Restoration Treatment & Atraumatic Restorative Treatment in Restoration of Primary Molars—A Randomized Controlled Trial"  focuses on evaluating two minimally invasive dental treatments: Silver Modified Atraumatic Restorative Treatment (SMART) and Atraumatic Restorative Treatment (ART). The study aims to compare their effectiveness, cost-efficiency, and impact on Oral Health-Related Quality of Life (OHRQoL) in children aged 6 to 11 with carious primary molars. It employs a randomized controlled trial involving 130 lesions, assessing outcomes like survival rates of restorations, treatment costs, and the time required for each procedure. The results are intended to inform more cost-effective and patient-friendly approaches to managing childhood dental caries, with a particular focus on outreach settings to reduce healthcare costs while improving oral health outcomes. 
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