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CTRI Number  CTRI/2025/04/085720 [Registered on: 28/04/2025] Trial Registered Prospectively
Last Modified On: 26/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing Two materials for Indirect Occlusal Veneers: A clinical trial 
Scientific Title of Study   Clinical Evaluation of Indirect Occlusal Veneers made with two different materials- An invivo 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  Dr Keyur Vala 
Designation  PG Student 
Affiliation  Government Dental College and Hospital, Ahmedabad 
Address  Room no. -9, Department of Conservative Dentistry and Endodontics, Government Dental College and Hospital, Ahmedabad, India, Pin- 380016
Civil Hospital Campus, Asarwa, Ahmedabad
Ahmadabad
GUJARAT
380016
India 
Phone  9537581009  
Fax    
Email  keyur.vala30797@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nupur Dhanak 
Designation  Assistant Professor 
Affiliation  Government Dental College and Hospital, Ahmedabad 
Address  Department of Conservative Dentistry and Endodontics, Government Dental College and Hospital, Civil Hospital Campus, Asarwa, Ahmedabad

Ahmadabad
GUJARAT
380016
India 
Phone  9428198077  
Fax    
Email  bhavsarnupur@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Keyur Vala 
Designation  PG Student 
Affiliation  Government Dental College and Hospital, Ahmedabad 
Address  Room no. -9, Department of Conservative Dentistry and Endodontics, Government Dental College and Hospital, Ahmedabad, India, Pin- 380016
Civil Hospital Campus, Asarwa, Ahmedabad
Ahmadabad
GUJARAT
380016
India 
Phone  9537581009  
Fax    
Email  keyur.vala30797@hotmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Government Dental College and Hospital 
Address  Department of Conservative Dentistry and Endodontics, Government Dental College and Hospital, Ahmedabad, India, Pin -380016 
Type of Sponsor  Other [Government Dental College 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 Keyur Vala  Government Dental College and Hospital, Ahmedabad  Room no.-9, Department of Conservative Dentistry and Endodontics, Government Dental College and Hospital, Ahemedabad
Ahmadabad
GUJARAT 
09537581009

keyur.vala30797@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Clinical Evaluation of Indirect Occlusal veneer made with lithium disilicate at the end of 6 months   Patients with localized or generalized tooth wear, with complain of sensitivity and chewing difficulty in premolars and molars are considered. Molars or Premolars are prepared with minimally invasive chamfer margin and then restored with Lithium disilicate indirect restorations which are bonded.  
Comparator Agent  Clinical Evaluation of Indirect Occlusal veneer made with zirconia reinforced lithium silicate at 6 months  Patients with localized or generalized tooth wear, with complain of sensitivity and chewing difficulty in premolars and molars are considered. Molars or Premolars are prepared with minimally invasive chamfer margin and then restored with zirconia reinforced Lithium silicate indirect restorations which are bonded.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  (a) Age 18-70 years
(b) Optimal oral hygiene.
(c) Patients with molar-incisor hypomineralization
(d) Patients with attrition, abrasion, erosion and biocorrosion
 
 
ExclusionCriteria 
Details  (a) Patients with poor oral hygiene
(b) Heavy smokers or patients with tobacco chewing
(c) Pregnant or lactating women 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Zirconia reinforced lithium silicate will perform better than lithium disilicate  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   20/05/2025 
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="0"
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  

In modern restorative dentistry, the emphasis has shifted toward minimally invasive approaches to manage tooth wear, particularly on occlusal surfaces, while conserving healthy tooth structure. Biocorrosion, caused by chemical, biological, and electrochemical interactions (e.g., dietary acids, GERD), is now a major contributor to tooth wear alongside abrasion and attrition. These conditions can impair aesthetics, reduce vertical dimension, and compromise oral function and quality of life.

Historically, full-coverage crowns following elective root canals were the standard treatment, but they involve significant tooth reduction and associated complications. In contrast, partial coverage restorations like inlays, onlays, overlays, and occlusal veneers have emerged as conservative, biomechanically favorable alternatives.

Occlusal veneers—also known as tabletop restorations—are especially useful for severe occlusal wear. They preserve enamel and require proper bonding protocols and material selection to ensure long-term success. Among restorative materials:

  • Lithium disilicate ceramics (e.g., IPS e.max Press) offer a balance of strength, esthetics, and reliable bonding.

  • Zirconia-reinforced lithium silicate ceramics (e.g., Celtra Press) provide enhanced strength and crack resistance with good bonding and optical properties.

    While promising, most data on material performance come from in vitro studies, and there’s a lack of robust  clinical comparisons. Therefore, this study aims to evaluate the clinical performance, survival and complications of lithium disilicate vs. zirconia-reinforced lithium silicate occlusal veneers in vivo.

 
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