| 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
|
|
|
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
|
|
|
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. |