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CTRI Number  CTRI/2026/01/102245 [Registered on: 28/01/2026] Trial Registered Prospectively
Last Modified On: 28/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluation of Layered Zirconia and Zirconia-Reinforced Lithium Disilicate Crowns 
Scientific Title of Study   Comparative Clinical Evaluation of Layered Zirconia and Zirconia-Reinforced Lithium Disilicate Crowns: A Randomized Controlled 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 Prasad N Masske 
Designation  Assistant Professor 
Affiliation  PIMS-DU Loni 
Address  Rural Dental College PIMS-DU Loni
OPD NO 401 DEPARTMENT OF Prosthodontics
Ahmadnagar
MAHARASHTRA
413736
India 
Phone  9022776222  
Fax  02422273413  
Email  drprasadmhaske@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prasad N Masske 
Designation  Assistant Professor 
Affiliation  PIMS-DU Loni 
Address  Rural Dental College PIMS-DU Loni
OPD NO 401 DEPARTMENT OF Prosthodontics
Ahmadnagar
MAHARASHTRA
413736
India 
Phone  9022776222  
Fax  02422273413  
Email  drprasadmhaske@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Prasad N Masske 
Designation  Assistant Professor 
Affiliation  PIMS-DU Loni 
Address  Rural Dental College PIMS-DU Loni
OPD NO 401 DEPARTMENT OF Prosthodontics
Ahmadnagar
MAHARASHTRA
413736
India 
Phone  9022776222  
Fax  02422273413  
Email  drprasadmhaske@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Nil 
Address  NA 
Type of Sponsor  Other [Self funded] 
 
Details of Secondary Sponsor  
Name  Address 
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 Prasad N Masske  PIMS-DU Loni  Department of Prosthodontics Rural Dental College PIMS-DU Loni
Ahmadnagar
MAHARASHTRA 		 09022776222
02422273413
drprasadmhaske@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC PIMS-DU LONI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Adequate occlusal clearance for material thickness Good oral hygiene and periodontal health No history of parafunctional habits  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  layered zirconia crowns  Traditional layered zirconia crowns in which zirconia core with feldspathic porcelain layering 
Intervention  zirconia-reinforced lithium disilicate crown.  These are a newer restoration offer enhanced aesthetic properties and better bonding tooth structure 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Adults 18–60 years requiring single-unit posterior or anterior crowns with written consent
Adequate occlusal clearance for material thickness
Good oral hygiene and periodontal health
No history of parafunctional habits
 
 
ExclusionCriteria 
Details  Severe bruxism or clenching
Patients with gingivitis and periodontitis
Heavy occlusal loads or malocclusion
Patients with systemic conditions affecting healing e.g. uncontrolled diabetes, osteoporosis
History of allergic reactions to ceramic materials
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Fracture/chipping rate of the crowns
Survival rate over the study period
Marginal adaptation and retention
 		 At 6 months, 1 year, 2 years
 
 
Secondary Outcome  
Outcome  TimePoints 
Patient satisfaction (measured using a Visual Analog Scale)
Colour stability and translucency over time
Wear resistance and antagonist tooth wear
Periodontal health around restorations (gingival index, plaque index)
 		 At 6 months, 1 year, 2 years 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   15/02/2026 
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="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  

Aim

To compare the Clinical Evaluation of Layered Zirconia and Zirconia-Reinforced Lithium Disilicate crowns in posterior and anterior restorations over a period of two years.

OBJECTIVES

  To compare the survival rates in Layered Zirconia and Zirconia-Reinforced Lithium Disilicate crowns.

  To compare the fracture resistance in Layered Zirconia and Zirconia-Reinforced Lithium Disilicate crowns.

To compare the aesthetic performance in Layered Zirconia and Zirconia-Reinforced Lithium Disilicate crowns and

  To compare the patient satisfaction of layered zirconia vs. zirconia-reinforced lithium disilicate Zr-LD crowns in posterior and anterior restorations over a 2 year period.

STUDY DESIGN

Type  Prospective, triple-blind, randomized controlled trial RCT

Participants 97 patients requiring single-unit posterior or anterior crowns will be allocated randomly and allocation concealment will be done.

Groups Group 1 Layered zirconia crowns zirconia core with veneering ceramic

Group 2 Zirconia-reinforced lithium disilicate monolithic crowns

Follow-up  6 months, 1 year, 2 years.

Inclusion Criteria

Adults (18–60 years) requiring single-unit posterior or anterior crowns with written consent (Annexure I)

Adequate occlusal clearance for material thickness

Good oral hygiene and periodontal health

No history of parafunctional habits (e.g., bruxism)

Exclusion Criteria

Severe bruxism or clenching

Patients with gingivitis and periodontitis

Heavy occlusal loads or malocclusion

Patients with systemic conditions affecting healing (e.g., uncontrolled diabetes, osteoporosis)

History of allergic reactions to ceramic materials

Outcome Measures

Primary Outcomes

Fracture/chipping rate of the crowns

Survival rate over the study period

Marginal adaptation and retention

Secondary Outcomes

Patient satisfaction measured using a Visual Analog Scale

Colour stability and translucency over time

Wear resistance and antagonist tooth wear

Periodontal health around restorations gingival index, plaque index

METHODOLOGY

Sample size calculation will be done using Statulator, a sample calculator.

  Sample size is 97 based on with 0.95 level of confidence, 0.5 expected proportion and 0.1 absolute value of margin of error.

   Calibration and training of the observer will be done for reliability and validity of the questionnaires

Pilot study will be done on 10 percent of the total sample size

Patients will be randomly assigned to receive either a layered zirconia or a zirconia-reinforced lithium disilicate crown.

Patients, evaluators and statistician will be blinded to the material used. The prosthodontist performing the restorations will not be blinded due to procedural requirements.

 Allocation concealment Patients will be allocated in two groups.

Clinical Procedures

Standardized tooth preparation (1.5–2.0 mm occlusal reduction, chamfer margin)

Conventional impressions recorded and compared

Crowns cemented using standardized adhesive protocols

Follow-Up Assessments:

At 6 months, 1 year, 2 years.

Evaluations will include radiographic analysis, clinical examination, and patient-reported outcomes

 
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