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CTRI Number  CTRI/2025/04/085599 [Registered on: 24/04/2025] Trial Registered Prospectively
Last Modified On: 23/04/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Performance of single unit 3D printed permanent resin crown 
Scientific Title of Study   Evaluation of clinical performance of single unit 3D printed permanent resin crown. 
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 Swapna B V 
Designation  Assistant Professor  
Affiliation  Manipal College of dental Sciences, Manipal 
Address  Department of Prosthodontics and Crown and Bridge, Manipal College of Dental Sciences, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9880359889  
Fax    
Email  swapna.bv@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Swapna B V 
Designation  Assistant Professor  
Affiliation  Manipal College of dental Sciences, Manipal 
Address  Department of Prosthodontics and Crown and Bridge, Manipal College of Dental Sciences, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9880359889  
Fax    
Email  swapna.bv@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Swapna B V 
Designation  Assistant Professor  
Affiliation  Manipal College of dental Sciences, Manipal 
Address  Department of Prosthodontics and Crown and Bridge, Manipal College of Dental Sciences, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9880359889  
Fax    
Email  swapna.bv@manipal.edu  
 
Source of Monetary or Material Support  
Manipal Academy of higher education, Manipal, Udupi,Karnataka 576104  
 
Primary Sponsor  
Name  Dr Swapna B V 
Address  Department of Prosthodontics and Crown and Bridge Manipal college of Dental Sciences, Manipal- 576104,Udupi, Karnataka, India  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Vinu Thomas George   Department of Prosthodontics and Crown and Bridge, Manipal college of Dental Sciences, Manipal- 576104, Udupi, Karnataka, India  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Swapna B V  Manipal College Of Dental Sciences   Room no 5, Department of Prosthodontics, Manipal College Of Dental Sciences Manipal Udupi KARNATAKA
Udupi
KARNATAKA 		 9880359889

swapna.bv@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe Kasturba Medical College and Kasturba Hospitals   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  3D printed crowns using different 3D printed materials   Group 2- 3D printed crowns using permanent resin (Saremco ) 
Intervention  3D printed crowns using two different 3D printed materials   Group 1 - 3D printed crowns using permanent resin (C and B permanent Prevest Denpro)  
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patient with periodontally healthy vital/nonvital teeth with adequate occlusal gingival height and no signs of bone resorption or periapical pathology.

 
 
ExclusionCriteria 
Details 
1. Patients with poor oral hygiene, reduced crown length, and periodontal disease will be excluded.
2. Pregnant patients, elderly, Physically challenged patients  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
evaluation will enable clinicians to better grasp the characteristics of these materials, thereby aiding in the informed selection of the most suitable material for specific clinical cases.  outcome will be assessed after 2weeks , 6 months and 1 year after cementation.  
 
Secondary Outcome  
Outcome  TimePoints 
The best 3D printed permanent material for crown and bridges will be identified.  Patient satisfaction score will be assessed after 1 year of cementation. 
 
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   N/A 
Date of First Enrollment (India)   26/05/2025 
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="2"
Months="0"
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   Forty patients will be selected on the inclusion and exclusion criteria and will be divided into two groups with twenty patients receiving three dimensional  printed crowns from different resin groups. Patient  with  periodontally healthy vital or nonvital teeth with adequate occlusal gingival height and no signs of bone resorption or periapical pathology will be included. Tooth preparation will be done according to the standard operating procedure. The prepared tooth will be digitally scanned, and the crown will be designed with software and the crowns will be printed. The crowns will be cemented using resin cement with standard protocol. The patient will be recalled after two weeks and  six  months and one year intervals. During recall the crown will be evaluated using modified Ryge criteria. 
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