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CTRI Number  CTRI/2025/04/085549 [Registered on: 24/04/2025] Trial Registered Prospectively
Last Modified On: 22/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparison of success of composite resin and glass ionomer cement restorative materials after silver diamine fluoride application in Class I cavities of primary molars 
Scientific Title of Study   Clinical and radiographical evaluation of the effectiveness of silver diamine fluoride on the success of composite resin and glass ionomer cement in class I restorations in deciduous molars: A randomized clinical study 
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 Malayka Shah 
Designation  Post graduate student  
Affiliation  Karnavati School of Dentistry 
Address  A-907,Karnavati University, Department of Pediatric and Preventive Dentistry, Adalaj-Uvarsad road, Gandhinagar

Gandhinagar
GUJARAT
382422
India 
Phone  8238382150  
Fax    
Email  malaykashah1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Megha Patel 
Designation  Head of Department  
Affiliation  Karnavati School of Dentistry 
Address  A-907, Karnavati University, Department of Pediatric and Preventive Dentistry, Adalaj-Uvarsad road, Gandhinagar

Gandhinagar
GUJARAT
382422
India 
Phone  9824400464  
Fax    
Email  meghapatel@karnavatiuniversity.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Megha Patel 
Designation  Head of Department  
Affiliation  Karnavati School of Dentistry 
Address  A-907,Karnavati University, Department of Pediatric and Preventive Dentistry, Adalaj-Uvarsad road, Gandhinagar


GUJARAT
382422
India 
Phone  9824400464  
Fax    
Email  meghapatel@karnavatiuniversity.edu.in  
 
Source of Monetary or Material Support  
Department of Pediatric and Preventive Dentistry, Karnavati School Of Dentistry, A/907 Karnavati University, Adalaj-Uvarsad Road, Gandhinagar - 382422 Gujarat, India 
 
Primary Sponsor  
Name  Dr Malayka Shah 
Address  Department of Pediatric and Preventive Dentistry, Karnavati School Of Dentistry, A/907 Karnavati University, Adalaj-Uvarsad Road, Gandhinagar - 382422 Gujarat, India 
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 Malayka Shah  Karnavati School of Dentistry  A-907, Karnavati University, Department of Pediatric and Preventive Dentistry, Adalaj-Uvarsad road - 382422
Gandhinagar
GUJARAT 		 8238382150

malaykashah1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Karnavati school of dentistry ethics committee (KSDEC)  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 
Intervention  Silver Diamine Fluoride and Composite restorative material   Complete caries excavation from the walls of the cavity and selective caries excavation to be done from the floor of Class 1 cavities of carious primary molars followed by Silver Diamine Fluoride application on the cavity floor and light curing it.After which the cavity is to be restored with composite resin. 
Comparator Agent  Silver Diamine Fluoride and Glass Ionomer Cement   Complete caries excavation from the walls of the cavity and selective caries excavation to be done from the floor of Class 1 cavities of carious primary molars followed by Silver Diamine Fluoride application on the cavity floor and light curing it.After which the cavity is to be restored with glass ionomer cement. 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  1. Patients aged 4 to 9 years
2. Primary molars requiring new Class I (ICDAS 3 TO ICDAS 5)
3. Vital teeth with normal appearance and morphology
4. Teeth to be restored should be in occlusion
5. Normal periodontal status
6. Absence of radiographic pulpal involvement of dental caries.
7. Absence of any periapical pathology
8. Absence of furcal involvement
9. Good oral hygiene
10. A good likelihood of recall availability 
 
ExclusionCriteria 
Details  1. Child below 4 years and above 9 years of age
2. Patients not signing consent.
3. Children lacking understanding ability
4. Children with physical & psychological disabilities
5. Children with underlying systemic diseases.
6. Unable to return for follow-ups;
7. Patients with partially erupted molars.
8. History of allergy to latex Children with silver allergy, oral ulcerations, or canker sores
9. Children with advanced gum disease
10. Physiological root resorption more than Apical 1/3rd of the root surface.
11. Signs of internal resorption/ external resorption.
12. Caries involving pulp
13.Periapical pathology
14. Signs of furcation involvement 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
CLINICAL SUCCESS
Color match, Marginal discoloration, Secondary caries, Marginal Adaptation, Anatomic form, Surface Texture, Gross fracture, Post-operative Sensitivity 		 Baseline, 3 months, 6 months, 9 months 
 
Secondary Outcome  
Outcome  TimePoints 
Marginal integrity  Baseline, 3 months, 6 months, 9 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   09/05/2025 
Date of Study Completion (India) 18/02/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 18/02/2026 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 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  

Dental caries remains one of the most common dental diseases globally and is a leading cause of toothache and tooth loss. Defined by Fejerskov and Kidd as the localized destruction of dental hard tissues by acidic by-products from bacterial fermentation of dietary carbohydrates, it is particularly concerning in the form of Early Childhood Caries (ECC). ECC is a severe and rapidly progressing form of caries affecting the primary teeth of infants and toddlers, often beginning on anterior surfaces and potentially affecting molars. It starts as a white spot lesion and can lead to complete crown destruction and cavitation.

Early intervention is critical for maintaining the overall health and development of a child. Healthy primary teeth are vital for chewing, speech, aesthetics, and maintaining proper space for permanent teeth. Untimely loss of primary teeth can lead to complications in oral and facial development. Timely restorative care also minimizes the need for local anesthesia and supports better behavior management during dental visits.

Modern caries management emphasizes early detection, prevention, and minimally invasive treatments. Current practices favor conservative removal of caries followed by restoration using materials such as glass ionomer cement (GIC) or composite resins, with a move away from amalgam restorations. Non-invasive strategies include the use of fissure sealants, resin infiltration, topical silver diamine fluoride (SDF), and the Hall technique. Techniques like atraumatic restorative treatment (ART) and stepwise caries removal also focus on preserving pulp vitality by avoiding unnecessary exposure.

Silver diamine fluoride (38% SDF) has emerged as an effective agent in arresting carious lesions, especially in primary molars. Compared to no treatment or fluoride varnish, SDF is more effective at preventing caries progression and has shown comparable results to GIC restorations. Its effectiveness increases with repeated applications, offering a non-invasive, child-friendly approach to caries management.

 
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