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CTRI Number  CTRI/2025/08/093250 [Registered on: 19/08/2025] Trial Registered Prospectively
Last Modified On: 18/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study Comparing the Fit of Dental Crowns Made by Traditional Casting, 3D Printing, and CAD/CAM Milling in Patients. 
Scientific Title of Study   Comparative evaluation of marginal fit and internal fit of crowns fabricated with traditional casting, 3D printing (DMLS), and CAD/CAM milling using silicone replica technique: An in vivo 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 Arushi Nihala 
Designation  MDS 1st year student 
Affiliation  Government Dental College Raipur 
Address  Room no 3 Department of Prosthodontics Government Dental College Raipur Chhattisgarh

Raipur
CHHATTISGARH
492001
India 
Phone  07879616907  
Fax    
Email  aarushinihala1998@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajendra kumar Dubey 
Designation  Professor 
Affiliation  Government Dental College Raipur 
Address  Room no 3 Department of Prosthodontics Government Dental College Raipur Chhattisgarh

Raipur
CHHATTISGARH
492001
India 
Phone  9229927756  
Fax    
Email  rkdubey2005@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Rajendra kumar Dubey 
Designation  Professor 
Affiliation  Government Dental College Raipur 
Address  Room no 3 Department of Prosthodontics Government Dental College Raipur Chhattisgarh

Raipur
CHHATTISGARH
492001
India 
Phone  9229927756  
Fax    
Email  rkdubey2005@yahoo.co.in  
 
Source of Monetary or Material Support  
Government Dental College Raipur Chhattisgarh India 492001 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 Arushi Nihala  Government Dental College  Room no 03 Department of Prosthodontics Government Dental College Raipur
Raipur
CHHATTISGARH 		 7879616907

aarushinihala1998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Government Dental College Raipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Crowns fabricated using CAD/CAM Milling  Fabrication and placement of crown using CAD CAM milling, followed by evaluation of marginal and internal fit using the Silicone Replica Technique. 
Intervention  Crowns fabricated using Three Dimensional Printing (Direct Metal Laser Sintering)  Fabrication and placement of crown using Three Dimensional Printing (Direct Metal Laser Sintering), followed by evaluation of marginal and internal fit using the Silicone Replica Technique. 
Comparator Agent  Crowns fabricated using Traditional Casting  Metal crown fabricated using the lost wax technique and conventional casting method, evaluated for marginal and internal fit using the Silicone Replica Technique in vivo. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients aged 18 to 60 years requiring a full coverage crown on posterior teeth.
Periodontally healthy posterior teeth.
Absence of fractures or periapical pathology in the selected tooth.
Patients willing and able to provide written informed consent and comply with the study protocol.
 
 
ExclusionCriteria 
Details  Anterior teeth requiring full coverage crowns.
Patients with active periodontal disease affecting the selected tooth.
Patients with systemic conditions affecting oral health (e.g. uncontrolled diabetes, osteoporosis).
Patients unwilling or unable to return for follow up examinations.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
This study will help us to evaluate the marginal and internal fit of crowns fabricated using three different manufacturing techniques.  baseline,6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Assessing the impact of various manufacturing techniques on crown adaptation and overall fit, determining the most accurate manufacturing technique that enhances prosthetic rehabilitation and ensures long-term success in clinical situations.  3 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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/ Phase 4 
Date of First Enrollment (India)   29/08/2025 
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)   Open to Recruitment 
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   This in vivo study aims to compare the marginal fit and internal fit of crowns fabricated using three different manufacturing techniques, namely traditional casting, three dimensional printing by direct metal laser sintering, and computer aided design and computer aided manufacturing milling. Metal crown will be fabricated using each technique and evaluated using the silicone replica technique. The results will help determine the most accurate method for achieving optimal crown fit, thereby improving the longevity and clinical performance of fixed dental prostheses. 
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