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CTRI Number  CTRI/2025/06/089809 [Registered on: 30/06/2025] Trial Registered Prospectively
Last Modified On: 27/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of three different Restorative Materials in Primary Molars 
Scientific Title of Study   Clinical and radiographic evaluation of conventional glass ionomer cement, flowable resin reinforced glass ionomer cement and self-adhesive fluoride releasing composite restorations in primary molars: a comparative randomized clinical 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 Mahesh Dadpe 
Designation  Head Of The Department 
Affiliation  MIDSR DC, Latur 
Address  Room no.6, Pediatric and preventive dentistry, MIDSR DC, Ambejogai Road, latur pin:413512

Latur
MAHARASHTRA
413512
India 
Phone  9823733222  
Fax    
Email  drmaheshdadpe@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Vaidehi Domale 
Designation  Post Graduate Student 
Affiliation  MIDSR Dental College, Latur, Maharashtra 
Address  Room no.6, ground floor, Department of Pediatric and Preventive Dentistry, MIDSR Dental College, Latur.

Latur
MAHARASHTRA
413512
India 
Phone  9309979718  
Fax    
Email  domalevaidehi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mahesh Dadpe 
Designation  Head Of The Department 
Affiliation  MIDSR DC, Latur 
Address  Room no.6, Pediatric and preventive dentistry, MIDSR DC, Ambejogai Road, latur pin:413512

Latur
MAHARASHTRA
413512
India 
Phone  9823733222  
Fax    
Email  drmaheshdadpe@gmail.com  
 
Source of Monetary or Material Support  
Room No. 6 Department Of Pediatric And Preventive Dentistry MIDSR Dental College, Latur Pin: 413512 
 
Primary Sponsor  
Name  Vaidehi Domale 
Address  Room No. 6 Department Of Pediatric And Preventive Dentistry MIDSR Dental College, Latur Pin: 413512 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Dr Mahesh Dadpe  Room No. 6 Department Of Pediatric And Preventive Dentistry MIDSR Dental College, Latur Pin: 413512 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mahesh Dadpe  MIDSR Dental College  Room No. 6, Ground floor, Department Of Pediatric And Preventive Dentistry
Latur
MAHARASHTRA 
9823733222

drmaheshdadpe@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee MIDSR,Latur   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Children in need with restoration of primary teeth. 
Patients  (1) ICD-10 Condition: K02||Dental caries,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional glass ionomer cement (GC Fuji IX)  Anatomic form, Secondary caries, Marginal discoloration, Marginal adaptation/ integrity, Post-operative sensitivity after 3 month, 6 month, 12 month 
Intervention  Light cure flowable glass ionomer cement Kids-e-Restore and Self-adhesive fluoride releasing composite Surefil one  Anatomic form, Secondary caries, Marginal discoloration, Marginal adaptation/ integrity, Post-operative sensitivity after 3 month, 6 month, 12 month 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  Aged 3-8 years

International caries detection and assessment system ICDAS score ranging from 3–5

Frankel’s Behaviour rating scale score of 3 or 4 
 
ExclusionCriteria 
Details  Primary molars with deep carious lesion

Presence of any pulpal disease with or without pain

Primary molars with developmental defects

History of allergy to any material being used

History of abnormal parafunctional activity

Participant with mental disability and systemic illness 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
evaluate and compare clinical and radiographical efficacy of light cure flowable resin reinforced glass ionomer cement, self-adhesive fluoride releasing composite and conventional glass ionomer cement when used as a restorative material in primary molars  3 month, 6 month,12 month 
 
Secondary Outcome  
Outcome  TimePoints 
evaluate and compare clinical and radiographical efficacy of self-adhesive fluoride releasing composite, light cure flowable resin reinforced glass ionomer cement and conventional glass ionomer cement when used as a restorative material in primary molars.  3 month, 6 month,12 month 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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)   28/07/2025 
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  

Dental caries is a multifactorial, dynamic, diet-modulated, biofilm-mediated disease that causes a net mineral loss in the tooth hard tissues. It is regarded as a serious public health issue and is the most prevalent noncommunicable disease in the world. Approximately 530 million children worldwide suffer from caries in their primary teeth, compared to an estimated 2.3 billion adults with caries in their permanent teeth. Caries management in children requires careful selection of restorative material with restorations lasting until teeth exfoliates. While for decades amalgam has been preferred due to moisture tolerance, ease of placement, and low cost. However, its use has been declined due to poor aesthetics and detrimental health effects caused by mercury release. However, Glass ionomer cement (GIC) is the most commonly used amalgam substitute. As it has the advantages of chemically adhesion to tooth structure, highly biocompatible and releases fluoride over time to provide a cariostatic effect. On the other hand, it has poor wear resistance, a slow setting rate, low fracture toughness, susceptibility to moisture contamination and dehydration during the initial setting phase. To overcome this, an interesting advancement was introduced High-viscosity glass-ionomer (HVGI), marketed under the trade name of Kids-e-Restore, which is self-adhesive, light-cured, flowable, and ready to use resin-reinforced glass ionomer restorative material. It promotes antimicrobial and anticaries activity by releasing fluoride and its self-adhesive technology eliminates the need for etching and bonding processes with chemical adhesion. Although, one of the most common restorative materials for primary tooth restorations is composite resin, which outperforms GICs in terms of aesthetics, wear resistance, and fracture resistance. Even though, composite resins do not release fluoride and exhibit polymerization shrinkage after setting, which can result in postoperative sensitivity, marginal discoloration, and secondary caries. Therefore, dentists need an alternative to composite or GICs which is affordable, releases fluoride,  simple to use, and has acceptable strength and aestheticsHowever, in recent introduction of a novel restorative material, known as Surefil one (Dual-cured composites), which is a self-adhesive fluoride-releasing composite, has been introduced to enable the easy application of bulk-fill composites up to 4-5 mm thick. Additionally, self-adhesive composites have been created by adding acidic moieties to reactive diluents so they will adhere to dentin and enamel. This Dual-cured composites consist of two initiator systems with light-cured and chemical-cured components. The initiator polymerizes top layers and initial hardening with light-cured reaction, while deeper layers are polymerized through a slow chemical-cured reaction. These composites have higher conversion values compared to light-cured bulk-fill and conventional composites, indicating better mechanical properties and degradation resistance. Surefil one  (Dual-cured bulk-fill materials) is used for direct restorations in a posterior-stress-bearing areas, requiring no capping, and different loads. In literature there are no in-vivo studies available comparing the clinical and radiographic efficiency of light cure flowable resin reinforced glass ionomer cement, self-adhesive fluoride-releasing composites and conventional glass ionomer cement in primary molars.

 
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