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CTRI Number  CTRI/2026/01/102610 [Registered on: 30/01/2026] Trial Registered Prospectively
Last Modified On: 30/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   A Study Comparing Fluoride-Based Fillings and Regular Composite Fillings for Back Teeth 
Scientific Title of Study   A randomized controlled trial to evaluate the performance of posterior Class I restorations using fluoride-releasing dental restoratives and bulk fill composite resin in an Indian population: A double-blind split-mouth 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  Ameya Mahavir Lokhande 
Designation  Reader 
Affiliation  TPCTs Terna Dental College 
Address  Terna Dental College, Department of Conservative Dentistry and Endodontics, Sector 22, Nerul (W)

Thane
MAHARASHTRA
400706
India 
Phone  9561236222  
Fax    
Email  thedentist222@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ameya Mahavir Lokhande 
Designation  Reader 
Affiliation  TPCTs Terna Dental College 
Address  Terna Dental College, Department of Conservative Dentistry and Endodontics, Sector 22, Nerul (W)

Thane
MAHARASHTRA
400706
India 
Phone  9561236222  
Fax    
Email  thedentist222@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ameya Mahavir Lokhande 
Designation  Reader 
Affiliation  TPCTs Terna Dental College 
Address  Terna Dental College, Department of Conservative Dentistry and Endodontics, Sector 22, Nerul (W)

Thane
MAHARASHTRA
400706
India 
Phone  9561236222  
Fax    
Email  thedentist222@gmail.com  
 
Source of Monetary or Material Support  
TPCYs Terna Dental College, Department of Conservative Dentistry and Endodontics, Room No 205, Sector 22, Nerul (W), Maharashtra, India 
 
Primary Sponsor  
Name  TPCTs Terna Dental College 
Address  TPCTs Terna Dental College, Department of Conservative Dentistry and Endodontics, Sector 22, Nerul (W), Maharashtra, India 
Type of Sponsor  Research institution and hospital 
 
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 Ameya Mahavir Lokhande  TPCTs Terna Dental College  TPCTs Terna Dental College, Department of Conservative Dentistry and Endodontics, Room No 205, Nerul West, Navi Mumbai, Maharashtra, India
Mumbai (Suburban)
MAHARASHTRA 		 09561236222

thedentist222@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
TPCTs Terna Dental college & Hospital Nerul Navi Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Teeth with Class I caries 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Filtek One Bulk-fill (Bulk-fill composite resin)  Filtek™ One Bulk Fill - 3M ESPE; St Paul, MN, USA 
Intervention  Zirconomer, Cention N, Beautifil Bulk Restorative (Fluoride-releasing materials)  Zirconomer – Shofu Inc.; Japan, Cention N – Ivoclar Vivadent; Schaan, Liechtenstein, Beautifil Bulk – Shofu Inc.; Japan 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  53.00 Year(s)
Gender  Both 
Details  Patients with with at least four single-surface occlusal caries on their posterior teeth. Patients diagnosed with at least four ICDAS code 4–5 carious lesions (Class I) in Mature Permanent Molar teeth. Single surface-occlusal caries restricted to fissures and do not involve cusps that are vital and without pulpal or periodontal disease, pain, and preoperative sensitivity; should be in occlusion with opposing natural teeth. Patients willing to come to follow-up appointments. 
 
ExclusionCriteria 
Details  Morbid Individuals with Systemic Diseases.
Decay involving Cusp, grossly carious teeth.
Partially erupted teeth.
Absence of antagonist teeth.
Teeth with interproximal caries.
Periodontally compromised teeth. 
 
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 
The clinical performance of the restorations evaluated using the modified USPHS criteria (including parameters such as marginal integrity, surface texture, color match, and secondary caries).  The restorations will be assessed at:

Baseline (immediately after placement),

4 weeks, and

8 weeks.

These time intervals will help determine both short-term performance and early clinical behavior of the materials. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   01/03/2026 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   The primary purpose of this protocol is to evaluate and compare the clinical performance of three fluoride-releasing restorative materials (Zirconomer, Cention N, and Beautifil Bulk Restorative) with a bulk-fill composite resin (Filtek One Bulk-fill) in Class I occlusal restorations of permanent molars over a 24-month period in an Indian population. The study aims to assess the restorations using revised FDI criteria, focusing on aesthetic, functional, and biological outcomes.

Null hypothesis:
There is no difference in the performance of posterior Class I restorations with Fluoride-releasing dental restoratives (Zirconomer, Cention N, and Beautifil Bulk Restorative) and Bulk-fill composite resin (Filtek One Bulk-fill) in an Indian Population.

Alternate hypothesis:
There is a difference in the performance of posterior Class I restorations with Fluoride-releasing dental restoratives (Zirconomer, Cention N, and Beautifil Bulk Restorative) and Bulk-fill composite resin (Filtek One Bulk-fill) in an Indian Population.
 
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