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CTRI Number  CTRI/2024/06/068331 [Registered on: 05/06/2024] Trial Registered Prospectively
Last Modified On: 11/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare the clinical success of teeth prepared using a new preparation technique and rehabilitated with zirconia crown or metal ceramic crown fabricated using computer aided design and manufacturing technology. 
Scientific Title of Study   Comparison of clinical outcomes of tooth prepared using biologically oriented preparation technique and restored with CAD CAM monolithic zirconia or metal-ceramic crowns: Randomized clinical 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. Ida Esther Celina 
Designation  Postgraduate Student 
Affiliation  Chettinad Dental College and Research Institute 
Address  E-Block, 3rd Floor, Room No.7, Department of Prosthodontics and Implantology.
Rajiv Gandhi Salai (OMR),
Kancheepuram
TAMIL NADU
603103
India 
Phone    
Fax    
Email  idaesthercelina@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Eazhil R 
Designation  Professor 
Affiliation  Chettinad Dental College and Research Institute 
Address  Department of Prosthodontics, Chettinad Dental College and Research Institute, Rajiv Gandhi Salai, Kelambakkam

Kancheepuram
TAMIL NADU
603103
India 
Phone  9841332224  
Fax    
Email  eazhil235@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr R Sridharan 
Designation  Professor and Head of the Department 
Affiliation  Chettinad Dental College and Research Institute 
Address  Department of Prosthodontics, Chettinad Dental College and Research Institute, Rajiv Gandhi Salai, Kelambakkam

Kancheepuram
TAMIL NADU
603103
India 
Phone  9444170808  
Fax    
Email  drmottu@hotmail.com  
 
Source of Monetary or Material Support  
Chettinad Dental College and Research Institute, Rajiv Gandhi Salai (OMR), Kancheepuram District, Kelambakkam - 603103. 
 
Primary Sponsor  
Name  Dr J Ida Esther Celina 
Address  Chettinad Dental College and Research Institute, Rajiv Gandhi Salai (OMR), E-Block, 3rd Floor, Room No.7, Department of Prosthodontics and Implantology, Kelambakkam, Kancheepuram District, Pin - 603103. 
Type of Sponsor  Other [Self] 
 
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 J Ida Esther Celina  Chettinad Dental College and Research Institute  Department of Prosthodontics, E - Block, 3rd Floor, Room No 7, Chettinad Health City, Rajiv Gandhi Salai(OMR), Kelambakkam - 603103
Kancheepuram
TAMIL NADU 
7358518682

prosthorctcdcri@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee - Chettinad Dental College and Research Institute  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, (2) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Tooth prepared with Biologically Oriented Preparation Technique (BOPT) and restored with CAD-CAM metal-ceramic crown  A single tooth that needs restoration with a crown after root canal treatment will be prepared using the BOPT technique and immediately restored with a temporary crown for 4 weeks. After 4 weeks they will receive a permanent CAD-CAM metal-ceramic crown. 
Intervention  Tooth prepared with Biologically Oriented Preparation Technique (BOPT) and restored with CAD-CAM Monolithic Zirconia Crown  A single tooth that needs restoration with a crown after root canal treatment will be prepared using the BOPT technique and immediately restored with a temporary crown for 4 weeks. After 4 weeks they will receive a permanent CAD-CAM monolithic zirconia crown. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1)18-45 years
2)Both males and females
3)Periodontally healthy molar or premolar teeth requiring full crowns after endodontic treatment
4)Unprepared or minimally restored contralateral tooth
5)Adequate crown-root ratio
6)Stable occlusion with a natural dentition in the opposing arch 
 
ExclusionCriteria 
Details  1)Teeth with pre-existing periodontal diseases (probing depth more than 3 mm)
2)Patients with Bruxism
3)Poor oral hygiene
4)The tooth with a short/malformed clinical crown
5)Teeth requiring post and core
6)Uncontrolled systemic diseases
7)Smoking and tobacco use
8)Pregnant and lactating mothers
9)Patients taking drugs that interfere with bone or soft tissue healing eg: Bisphosphonates and corticosteroids.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Total technical complications between monolithic zirconia and metal ceramic crown


Sample size was calculated using the total technical outcomes of metal ceramic crown (27.1%) and zirconia crown (5.4%) obtained from a previous study, 80% power, 5% alpha error. The total sample size was 35 per group which was increased to 40 per group (total 80 patients) to adjust for 10% dropout.  
Baseline, 6 months, 1 and 3 year 
 
Secondary Outcome  
Outcome  TimePoints 
1. Survival analysis – between monolithic zirconia and metal-ceramic crown.
2. Comparison of the Plaque index (Rustogi Modification of Navy Plaque Index) and the Bleeding index (Ainamo and Bay). 
Baseline, 6 months, 1 and 3 year 
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/06/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [prosthorctcdcri@gmail.com].

  6. For how long will this data be available start date provided 01-12-2027 and end date provided 31-12-2032?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Objectives: The purpose of this study is to compare the biological and mechanical outcomes of teeth prepared using biologically oriented preparation technique (BOPT) and restored with CAD-CAM zirconia or CAD-CAM Metal-ceramic crowns

Material and Methods: The study will be conducted as a single-center randomized clinical trial with two parallel arms. Ethical clearance will be obtained and the trial will be conducted according to the Declaration of Helsinki. Patients visiting the outpatient department of Prosthodontics will be enrolled according to the inclusion and exclusion criteria after obtaining informed/written consent. A total of 78 patients requiring single crowns in endodontically treated premolar or molar teeth will be randomized (1:1 ratio) to receive CAD-CAM Zirconia (ZIR Group) or CAD-CAM Metal Ceramic Crown (MCC Group).

       The tooth will be prepared according to the BOPT protocol and immediately restored with a temporary (provisional) crown. After 4 weeks the impressions for the permanent crowns will be made. The permanent CAD-CAM zirconia or CAD-CAM metal-ceramic crowns will be fabricated in the laboratory according to the manufacturer’s instructions. The permanent crowns will be cemented with glass ionomer cement. The outcome assessment will be done by an experienced clinician who will be blinded. The clinical performance of the crowns will be assessed using revised FDI criteria for direct and indirect restorations (2023). The definitive crowns that belong to the “sufficient category” (clinically excellent, clinically good, clinically satisfactory ) in the revised FDI criteria  (2023) will only be cemented others will be discarded and remade. Follow-up assessment will be done 1 week after the cementation of permanent crowns (baseline), at 6 months, 1 year, 2 years, and 3 years. Technical complications will be compared between the two groups and survival rate will be assessed using the Kaplan-Meir estimate after 1 and 3 years. The probing pocket depth, clinical attachment level,  plaque index (Rustogi Modification of Navy Plaque Index 1992), and bleeding on probing (Ainamo and Bay) will be measured 1 week after the cementation of permanent crowns (baseline), at 6 months, 1 year, 2 years, and 3 years and compared with the unrestored or minimally restored contralateral control tooth. 

 
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