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CTRI Number  CTRI/2026/04/108732 [Registered on: 20/04/2026] Trial Registered Prospectively
Last Modified On: 17/04/2026
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 dental filling materials for cavity treatment in primary teeth of children 
Scientific Title of Study   A comparative study to evaluate clinical performance of Alkasite restorative material and Glass Ionomer cement restorative material used for treatment of proximal caries in 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  Priya Gupta 
Designation  PG student 
Affiliation  Government college of Dentistry Indore 
Address  Room no. 18 ,1 Sardar Patel Marg ,opp. M.Y. Hospital, Indore

Indore
MADHYA PRADESH
452001
India 
Phone  08630483291  
Fax    
Email  priyaguptabds@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Ashish Saxena  
Designation  Professor and H.O.D 
Affiliation  Government college of Dentistry, Indore 
Address  Room no. 18 ,Department of Pediatric and Preventive Dentistry Govt College of Dentistry ,Indore 1 Sardar Patel Marg ,opp. M.Y. Hospital, Indore

Indore
MADHYA PRADESH
452001
India 
Phone    
Fax    
Email  drashishsaxena2005@gmail.com  
 
Details of Contact Person
Public Query  
Name  Priya Gupta 
Designation  PG student 
Affiliation  Government college of Dentistry Indore 
Address  Room no. 18 ,1 Sardar Patel Marg ,opp. M.Y. Hospital, Indore

Indore
MADHYA PRADESH
452001
India 
Phone  08630483291  
Fax    
Email  priyaguptabds@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Dr Priya Gupta 
Address  Room no.18,Department of Pediatric and Preventive Dentistry Govt College of Dentistry Indore , 1 Sardar Patel Marg ,opp. M.Y. Hospital, Indore 
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 Priya Gupta  Govt. College of Dentistry Indore  Room no. 18 ,Department of Pediatric and Preventive Dentistry, 1 Sardar Patel Marg ,opp. M.Y. Hospital, Indore
Indore
MADHYA PRADESH 		 08630483291

priyaguptabds@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, Govt. College of Dentistry, Indore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  DENTAL CARIES IN DECIDUOUS TEETH 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cention N   Cention N is a tooth-colored, dual-cure alkasite restorative material (Ivoclar Vivadent) indicated for direct posterior restorations, including Class II cavities in primary teeth. It consists of a powder and liquid system containing alkaline fillers that release fluoride, calcium, and hydroxide ions, providing bioactive and cariostatic properties. The material exhibits high compressive strength and low polymerization shrinkage due to isofiller technology. Procedure-After administration of local anesthesia, isolation (preferably rubber dam) is achieved. Caries excavation is carried out using minimally invasive techniques, followed by Class II cavity preparation. A matrix band is placed to achieve proper proximal contour. The material is mixed according to manufacturer instructions and inserted in bulk into the prepared cavity. It is allowed to self-cure (approximately 4 minutes), with optional light curing for 20 seconds. Finishing and polishing are done using standard polishing systems. Restorations are evaluated using modified Ryge criteria.  
Comparator Agent  Glass Ionomer Cement  Glass Ionomer Cement is a tooth-colored, water-based restorative material widely used in pediatric dentistry for restoring primary teeth. It consists of fluoroaluminosilicate glass powder and polyacrylic acid liquid. GIC has the ability to chemically bond to enamel and dentin and releases fluoride over time, providing a cariostatic effect. However, it has comparatively lower mechanical strength and wear resistance than newer restorative materials. Procedure -Caries removal is performed using minimally invasive techniques. A Class II cavity is prepared, and a matrix band is placed to establish proximal contour. The cavity is conditioned using polyacrylic acid for 10–20 seconds, rinsed, and gently dried. The GIC is mixed according to the manufacturer’s instructions and placed into the cavity. Restoration are evaluated using modified Ryge criteria.  
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  1. Consent from parents received.
2. Children age 5 to 9 years old;
3. Children with an ASA score of I (healthy) and Frankl rating scale 3 and 4 included.
4. Presence of two carious primary molars, with no signs of necrosis or pulpal involvement.
5. The caries had to be class II affecting the tooth.
6. The ICDAS score of the caries has to be lower than five (visible dentin in a distinct cavity)
 
 
ExclusionCriteria 
Details  1. Uncooperative or medically compromised child.
2. Developmental defects of teeth.
3. Pulp exposure indicating the need for extraction or endodontic treatment.
4. The ICDAS score greater than five.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the aesthetic, functional, biological properties of Alkasite and Glass Ionomer cement restorative material.  To compare the aesthetic, functional, biological properties of Alkasite and Glass Ionomer cement restorative material at baseline and 2 week  
 
Secondary Outcome  
Outcome  TimePoints 
1. To evaluate the aesthetic, functional, biological properties of Alkasite restorative material.
2. To evaluate the aesthetic, functional, biological properties of Glass Ionomer cement restorative material.
 		 1. To evaluate the aesthetic, functional, biological properties of Alkasite restorative material at baseline & 2 weeks.
2. To evaluate the aesthetic, functional, biological properties of Glass Ionomer cement restorative material
at baseline & 2 weeks.
 
 
Target Sample Size   Total Sample Size="39"
Sample Size from India="39" 
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)   28/04/2026 
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="0"
Months="1"
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 split-mouth in vivo study will compare the clinical performance of alkasite restorative material (Cention N) and Glass Ionomer Cement (GIC) in proximal caries of primary molars in children aged 5–9 years. A total of 39 participants will receive both restorations in different quadrants. Clinical evaluation will be done at using modified USPHS (Ryge) criteria assessing color match, marginal adaptation, marginal discoloration, anatomic form, and secondary caries. The study aims to determine whether alkasite can serve as an effective alternative to GIC.

 
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