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CTRI Number  CTRI/2026/01/100676 [Registered on: 09/01/2026] Trial Registered Prospectively
Last Modified On: 09/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparative Clinical Evaluation of Three Different Glass Ionomer Restorative Cements in Carious Primary Teeth 
Scientific Title of Study   Comparative Clinical Evaluation of Three Different Commercially Available Glass Ionomer Restorative Cements in Carious Primary Teeth : An In Vivo 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 Varinder Goyal 
Designation  Professor and Head of Department 
Affiliation  Guru Nanak Dev Dental College and Research Institute Sunam 
Address  Room no 5, Department of Paediatric and Preventive Dentistry. Guru Nanak Dev Dental College and Research Institute Sunam

Sangrur
PUNJAB
148028
India 
Phone  9855466666  
Fax    
Email  virinderg@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Varinder Goyal 
Designation  Professor and Head of Department 
Affiliation  Guru Nanak Dev Dental College and Research Institute Sunam 
Address  Room no 5, Department of Paediatric and Preventive Dentistry. Guru Nanak Dev Dental College and Research Institute Sunam

Sangrur
PUNJAB
148028
India 
Phone  9855466666  
Fax    
Email  virinderg@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Varinder Goyal 
Designation  Professor and Head of Department 
Affiliation  Guru Nanak Dev Dental College and Research Institute Sunam 
Address  Room no 5, Department of Paediatric and Preventive Dentistry. Guru Nanak Dev Dental College and Research Institute Sunam

Sangrur
PUNJAB
148028
India 
Phone  9855466666  
Fax    
Email  virinderg@gmail.com  
 
Source of Monetary or Material Support  
Department of Pediatric and Preventive Dentistry, Guru Nanak Dev Dental College and Research Institute, Sunam, Sangrur, Punjab, Pin:148028 
 
Primary Sponsor  
Name  Dr Gursimran Kaur 
Address  Department of Paediatric and Preventive Dentistry. Guru Nanak Dev Dental College and Research Institute, Sunam 
Type of Sponsor  Research institution 
 
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 Gursimran Kaur  Guru Nanak Dev Dental College and Research Institute  Room no 5. Department of Paediatric and Preventive Dentistry, Guru Nanak Dev Dental College and Research Institute, Sunam, Sangrur. Punjab
Sangrur
PUNJAB 		 8445817651

gursimran.kaur2211@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee  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  Flowable light-cured resin reinforced GIC   Caries excavation will be carried out after obtaining adequate isolation, using high speed diamond burs under constant water cooling. Isolate the tooth and gently blow with air syringe to remove excess moisture. A thin layer of Kids-e-Restore will be applied in increments of 2 mm or less into the prepared cavity and light cured for 20 sec using LED curing light followed by finishing, polishing and checking for any high occlusal points. 
Comparator Agent  Radiopaque light cured reinforced glass ionomer restorative   Caries excavation will be carried out after obtaining adequate isolation, using high speed diamond burs under constant water cooling. GC Dentin conditioner will be applied onto the cleaned tooth surface for 20 seconds, then rinsed with water and blot dried. The cement (GC Gold Label 2 LC) will be condensed into the prepared cavity and light cured for 20 seconds. High occlusal points will be removed followed by finishing and polishing. 
Intervention  Riva self cure GIC  Caries excavation will be carried out after obtaining adequate isolation, using high speed diamond burs under constant water cooling. Riva conditioner will be applied to the prepared surfaces after proper isolation and rinsed thoroughly with water after 10 seconds. Excess moisture will be removed and prepared cavities will be restored by Riva self cure glass ionomer restorative material. Finishing and polishing will be done along with removal of occlusal high points.  
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  Patients of age group 4-9 years.
Vital primary teeth with carious lesions without pulpal involvement.
Patients without any systemic conditions.
Cooperative children with Frankel behavioral rating scale positive and definitely positive.
 
 
ExclusionCriteria 
Details  Endodontically compromised tooth.
Presence of soft tissue abscess / sinus tract.
Pathological mobility, redness or swelling of the vestibule.
Patients with special care needs.
Uncooperative children with Frankel’s behavioral rating scale negative and definitely negative.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Clinical efficacy of these three glass ionomer cements will be analysed on the basis of: Color match, Cavosurface marginal discoloration, Anatomical form, Marginal adaptation, Retention, Secondary caries, Post-operative sensitivity
 		 1 week, 3 months and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="99"
Sample Size from India="99" 
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)   20/01/2026 
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="6"
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  

Dental restorations are essential procedures in dentistry aimed at repairing and restoring damaged or decayed teeth. They not only improve the functionality of teeth but also enhance aesthetics contributing to better oral health. The aim of present in-vivo study is to evaluate and compare the clinical efficacy of three different glass ionomer restorative cements i.e., Riva self cure glass ionomer restorative material (SDI) and Radiopaque light cured reinforced glass ionomer restorative (GC Gold Label 2 LC) with Injectable glass ionomer composite resin (Kids-e-Restore) for restoration of carious lesions in primary teeth. Total no. of 99 teeth will be taken on which cavities will be prepared. They will be randomly divided into three groups and the prepared cavities will be restored using respective glass ionomer cement. The data obtained will be tabulated and statistically analysed.

 
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