CTRI

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CTRI Number

CTRI/2025/04/084049 [Registered on: 03/04/2025] Trial Registered Prospectively

Last Modified On:

02/04/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Dentistry

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Comparing diffrent types of tooth fillings for cavities in childrens black teeth: A research study

Scientific Title of Study

Comparative Evaluation of Bioactive Resin Modified, Glass Hybrid and Conventional GIC in Class II Restorations of Primary Molars: A Randomized Controlled 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	Mayuri Sopan Mundhe
Designation	Junior Resident
Affiliation	King Georges Medical University
Address	Department add paediatric and preventive dentistry New dental building KGMU Lucknow Lucknow UTTAR PRADESH 226003 India
Phone	9049314952
Fax
Email	dr.mayuri75@gmail.com

Details of Contact Person
Scientific Query

Name	Rajeev Kumar Singh
Designation	Professor & HOD
Affiliation	King Georges Medical University
Address	Department add paediatric and preventive dentistry New dental building KGMU Lucknow Lucknow UTTAR PRADESH 226003 India
Phone	9450849528
Fax
Email	rajeevkumarsingh@kgmcindia.edu

Details of Contact Person
Public Query

Name	Mayuri Sopan Mundhe
Designation	Junior Resident
Affiliation	King Georges Medical University
Address	Department add paediatric and preventive dentistry New dental building KGMU Lucknow Lucknow UTTAR PRADESH 226003 India
Phone	9049314952
Fax
Email	dr.mayuri75@gmail.com

Source of Monetary or Material Support

No material/monetary support

Primary Sponsor

Name	Self sponsored
Address	Department of paediatric and preventive dentistry KGMU, Lucknow
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 Mayuri Sopan Mundhe	Faculty of dental sciences, KGMU	Department of paediatric and preventive dentistry KGMU Lucknow Lucknow UTTAR PRADESH	9049314952 dr.mayuri75@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
King Georges Medical University U.P., Institutional Ethical Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	WITH OCCLUSOPROXIMAL CARIES IN PRIMARY MOLARS
Patients	(1) ICD-10 Condition: K02\|\|Dental caries, (2) ICD-10 Condition: K02\|\|Dental caries,

Intervention / Comparator Agent

Type	Name	Details
Intervention	ACTIVA BIOACTIVE	ACTIVA BioACTIVE is an innovative dental restorative material developed by Pulpdent Corporation, combining the advantages of resin composites and glass ionomer cements. It is a bioactive material that releases and recharges essential minerals like fluoride, calcium, and phosphate, promoting remineralization and enhancing the longevity of restorations. The material features a moisture-friendly, rubberized-resin matrix that provides durability, shock absorption, and resistance to fracture. It chemically bonds to tooth structure, reducing microleakage and minimizing the risk of secondary caries. Free from Bisphenol A, Bis-GMA, and BPA derivatives, ACTIVA BioACTIVE is a safer alternative for restorative procedures, particularly in pediatric and preventive dentistry. It is available in different formulations, including ACTIVA BioACTIVE-Restorative and ACTIVA BioACTIVE-Base/Liner, making it a versatile choice for various clinical applications.
Comparator Agent	Conventional GIC(GC Fuji IX GP (Type 9 GIC)	GC Fuji IX GP (Type 9 GIC) is a high-strength, self-cured glass ionomer cement (GIC) developed by GC Corporation for posterior restorations, core build-ups, and bases under composite restorations. It features strong adhesion to dentin and enamel without the need for etching or bonding agents, ensuring an efficient and reliable seal. With its high fluoride release, it promotes remineralization and provides long-term caries prevention. The material exhibits enhanced wear resistance and improved fracture toughness compared to conventional GICs, making it suitable for high-stress areas such as class I and class II restorations in primary teeth and non-load-bearing restorations in permanent teeth. Its fast setting time, ease of handling, and excellent biocompatibility make GC Fuji IX GP a preferred choice in pediatric and geriatric dentistry.
Intervention	Equia forte	EQUIA Forte is an advanced glass hybrid restorative system developed by GC Corporation, combining the benefits of glass ionomer cement (GIC) and resin composite technology. It consists of EQUIA Forte Fil, a reinforced glass hybrid restorative, and EQUIA Forte Coat, a light-cured, highly filled resin coat that enhances durability and wear resistance. This system provides excellent fluoride release, chemical adhesion to the tooth structure, and superior marginal sealing, reducing the risk of microleakage and secondary caries. EQUIA Forte is particularly effective for posterior restorations, non-load-bearing class II cavities, and geriatric and pediatric cases due to its bulk-filling capability, high strength, and moisture tolerance. Its ease of application and long-term clinical performance make it a reliable alternative to conventional GICs and composites.

Inclusion Criteria

Age From	4.00 Year(s)
Age To	7.00 Year(s)
Gender	Both
Details	1. Occluso-proximal cavities in the primary maxillary and mandibular molars, International Caries Detection and Assessment System II (ICDAS II) codes 4 and 5 2. Asymptomatic, vital teeth without pulpal involvement. 3. Patient without systemic diseases that may interfere with dental treatment. 4. Teeth without any developmental defects such as hypomineralisation, hypoplasia, and fluorosis.

ExclusionCriteria

Details

1. Primary molars with extensive loss of tooth structure that exceeds the suitability
for a Class II restoration.
2. Teeth with periodontal or periapical pathology.
3. Patients with a history of adverse reactions to restorative dental materials.
4. Severe developmental or cognitive impairment that interferes with cooperation during dental procedure.
5. Inability of the patient to comply with the follow-up examinations and the requirements of the study.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Participant and Outcome Assessor Blinded

Primary Outcome

Outcome	TimePoints
Assess the clinical efficacy of ACTIVA BioACTIVE, Equia forte(glass hybrid) and conventional GIC in restoring class II carious lesions in primary molars.	1,6 and 12 months

Secondary Outcome

Outcome	TimePoints
To compare three materials in terms of Esthetic, Biological and Functional properties.	1, 6 and 12 months

Target Sample Size

Total Sample Size="105"
Sample Size from India="105"
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)

23/04/2025

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="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

Introduction

Dental materials for Class II restorations in primary molars play a critical role in pediatric dentistry. This study aims to evaluate and compare the clinical performance of three restorative materials: ACTIVA BioACTIVE, EQUIA Forte, and Conventional Glass Ionomer Cement (GIC). The evaluation focuses on factors such as retention, marginal integrity, and post-operative sensitivity.

Materials and Methods

The study enrolled pediatric patients requiring Class II restorations on primary molars. The materials used were:

ACTIVA BioACTIVE: A bioactive composite resin known for releasing and recharging fluoride and enhancing tooth structure.
EQUIA Forte: A glass hybrid restorative system with high wear resistance and fluoride release.
Conventional GIC: A traditional restorative material with chemical adhesion and fluoride-releasing properties.

Restorations were placed following standardized protocols. Clinical assessments were conducted at baseline, 3 months, 6 months, and 12 months. Parameters evaluated included retention, marginal adaptation, surface roughness, and post-operative sensitivity.

Discussion

The study highlights that ACTIVA BioACTIVE and EQUIA Forte outperform Conventional GIC in retention, marginal adaptation, and surface smoothness. ACTIVA BioACTIVE’s bioactive properties contribute to enhanced tooth remineralization and stress absorption, while EQUIA Forte’s glass hybrid technology offers superior mechanical strength and fluoride release.

Conventional GIC, despite its fluoride-releasing ability, displayed inferior performance due to its lower mechanical strength and increased surface roughness, which can lead to plaque retention and secondary caries.

Conclusion

ACTIVA BioACTIVE emerged as the most effective material for Class II restorations in primary molars, followed closely by EQUIA Forte. Conventional GIC, while still a viable option, showed limitations in long-term durability and surface smoothness. These findings support the use of bioactive and hybrid materials for improved clinical outcomes in pediatric restorative dentistry.