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CTRI Number  CTRI/2025/12/099652 [Registered on: 22/12/2025] Trial Registered Prospectively
Last Modified On: 19/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative Evaluation of Clinical Performance of Different Zirconia Containing Restorative Materials In Non-Carious Cervical Lesions-A Randomized Control Trial 
Scientific Title of Study   Comparative Evaluation of Clinical Performance of Different Zirconia Containing Restorative Materials In Non-Carious Cervical Lesions-A Randomized Control 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 Sandipan Atmaram Hajare 
Designation  Post Graduate Student 
Affiliation  Govt. Dental College and Hospital, Nagpur 
Address  117, Department of conservative dentistry and endodontics, Govt, dental college and hospital, Medical square, Nagpur

Nagpur
MAHARASHTRA
440003
India 
Phone  9284869725  
Fax    
Email  sandiphajare127127@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Darshan Dakshindas 
Designation  Associate Professor 
Affiliation  Govt. Dental College and Hospital, Nagpur 
Address  117, Department of conservative dentistry and endodontics, Govt, dental college and hospital, Medical square, Nagpur

Nagpur
MAHARASHTRA
440003
India 
Phone  9823286490  
Fax    
Email  ddakshindas22@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Darshan Dakshindas 
Designation  Associate Professor 
Affiliation  Govt. Dental College and Hospital, Nagpur 
Address  117, Department of conservative dentistry and endodontics, Govt, dental college and hospital, Medical square, Nagpur


MAHARASHTRA
440003
India 
Phone  9823286490  
Fax    
Email  ddakshindas22@gmail.com  
 
Source of Monetary or Material Support  
Government Dental College and Hospital, Medical Square,Nagpur-440003 
 
Primary Sponsor  
Name  Dr. Sandipan Hajare 
Address  117,Department of conservative dentistry and endodontics, Government dental college and Hospital, Nagpur 
Type of Sponsor  Other [{self sponsered}] 
 
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 Sandipan Hajare  Government Dental College and Hospital Nagpur  Room No. 117 Department of Conservative Dentistry and Endodontic, Government Dental College And Hospital, Nagpur
Nagpur
MAHARASHTRA 
9284869725

sandiphajare127127@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Government Dental College And Hospital, Nagpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K031||Abrasion of teeth, (2) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  3M Filltek Bulkfill  A flowable bulk-fill composite from 3M designed for easier and faster posterior restorations, allowing placement in larger increments (up to ~4 mm) compared to traditional composites. 3M India +1 Has a low-stress, flowable consistency that adapts well to cavity walls and is used for bases/liners, Class I/II restorations, minimal-invasive restorations, and small occlusal fillings. 3M India Ergonomic syringe and tip design reduce bubbles and improve handling. 3M India Formulated for strength, good wear resistance, radiopacity, and lower polymerization shrinkage stress compared with some traditional flowable composites.  
Comparator Agent  Tokuyama palifique asteria  Tokuyama Palfique Estelite (Estelite / Palfique Estelite) A light-cured dental composite resin from Tokuyama Dental used for restorations in anterior and posterior teeth. Tokuyama Dental Corporation Often part of the Palfique Estelite family (including variants like Estelite Asteria, a simplified layering composite with excellent esthetics and gloss). Tokuyama Dental Corporation Designed with supra-nano spherical fillers that improve polishability, shade adaptation and wear resistance. Trycare Estelite Asteria specifically uses a 2-step layering concept with minimal shades to cover a wide range of tooth colors, helping produce lifelike results with easy handling and long-lasting gloss 
Intervention  Zirconomer  Zirconomer Improved is developed as a reliable and durable tooth coloured zirconia reinforced posterior restorative. Novel nano-sized zirconia fillers enhance material translucency for a closer shade match to natural tooth with superior handling characteristics for a simple, easy and fast bulk placement. Considered a safe alternative to silver amalgam, it exhibits the strength and durability of amalgam and protective benefits of glass ionomer, while eliminating the hazards of mercury. Strong, durable and fluoride rich, Zirconomer Improved is ideal as a bulk fill restorative for structural cores and bases as well as cases with high caries risk. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with non carious cervical lesion in sound vital
permanent maxillary and mandibular incisor, canine and
premolar teeth
with fair oral hygiene.
and ideal oral hygiene practices.
 
 
ExclusionCriteria 
Details  Patients who are medically compromised.
Pregnant and lactating women.
Immature teeth or teeth with root resorption.
Periodontally compromised tooth.
Teeth with previous root canal treatment.
Badly carious teeth. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Marginal Discoloration, Colour Matching, Anatomical Contour, Retention Using modified USPHS Criteria and Postoperative Sensitivity Using VAS Scale  6th day, 3rd Month, 6th Month, 12 Month and 15th Month 
 
Secondary Outcome  
Outcome  TimePoints 
Postoperative Sensitivity Using VAS Scale  6th day, 3rd Month, 6th Month, 12 Month and 15th Month 
 
Target Sample Size   Total Sample Size="135"
Sample Size from India="135" 
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)   15/01/2026 
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="3"
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  

Non-carious cervical lesions (NCCL) present a significant restorative challenge for the dentist in bonding because adhesion is not as strong and predictable. The choice of restorative material is critical to restorative success. Clinicians have tried a variety of restorative materials and techniques to achieve the best results. The loss of tooth structure at the cemento- enamel junction is known as NCCLs. These lesions are referred by a number of names, including abfraction, erosion, and abrasion. These lesions range in shape from large wedge-shaped defects with sharp internal and external line angles to shallow grooves or broad dished out lesions. They are more common on the buccal surfaces of incisors, canine, and premolars . Since Bowen (1960) discovered a monomer called Bis GMA bisphenol, composite resin-based aesthetic dental materials have rapidly advanced. For the first time, an organosilane coupling agent and diglycidyl methacrylate are used to create a bond between the resin matrix and the filler particles. Bis-GMA, UDMA, and the co-monomer TEGDMA, are mixed with low-viscosity monomers to acquire more desirable viscosity, handling characteristics respectively to achieve specific features and properties  Dental nanocomposites, which have inorganic phases with distinctive dimensions in the range of 10–100 nm, can now be manufactured because of advancements in nanotechnologies in recent year.The properties and attributes of these novel forms of restorative materials, including their aesthetically pleasing appearance, are influenced by the nanocomposite materials with the filler content represented by zirconia and ceramics. The aim of this study is to compare, for a period of 15 months (according to the modified United States Public Health Service - USPHS - criteria), the clinical aspect of non-carious cervical lesions finished with three different zirconia containing materials.

 
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