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CTRI Number  CTRI/2024/03/063430 [Registered on: 01/03/2024] Trial Registered Prospectively
Last Modified On: 18/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare the accuracy of shade selection among classic shade guide, digital camera, smartphone and a digital shade guide for anterior all ceramic crown. 
Scientific Title of Study   A Comparison Of Shade Selection Accuracy among Classic Shade Guide, Digital Camera, Smartphone And Digital Shade Guide For All Anterior Ceramic Crown : 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  Rekha Gupta  
Designation  Professor and Head of the Department 
Affiliation  Maulana Azad Institute of Dental Sciences 
Address  Room no. 215,second floorDepartment of Prosthodontics, Maulana Azad Institute of Dental Sciences, MAMC Complex, B.S. Zafar Marg, New Delhi

Central
DELHI
110002
India 
Phone  9654700952  
Fax    
Email  dr_rekhagupta@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Rekha Gupta  
Designation  Professor and Head of the Department 
Affiliation  Maulana Azad Institute of Dental Sciences 
Address  Room no. 215, second floor,Department of Prosthodontics, Maulana Azad Institute of Dental Sciences, MAMC Complex, B.S. Zafar Marg, New Delhi


DELHI
110002
India 
Phone  9654700952  
Fax    
Email  dr_rekhagupta@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Gagan Kumar 
Designation  Postgraduate student 
Affiliation  Maulana Azad Institute of Dental Sciences 
Address  Room - 224, second floor,Department of Prosthodontics, Maulana Azad Institute of Dental Sciences, MAMC Complex, B.S. Zafar Marg, New Delhi

Central
DELHI
110002
India 
Phone  9899686894  
Fax    
Email  gagank802@gmail.com  
 
Source of Monetary or Material Support  
Maulana Azad Institute of Dental Sciences 
 
Primary Sponsor  
Name  Maulana Azad Institute of Dental Sciences 
Address  Maulana Azad Institute of Dental Sciences, MAMC Complex, B.S. Zafar Marg, New Delhi: 110002  
Type of Sponsor  Government medical college 
 
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 Rekha Gupta  Maulana Azad Institute of Dental sciences   Room 202, Department of Prosthodontics, second floor,Maulana Azad Institute of Dental Sciences, MAMC Complex, B.S. Zafar Marg, New Delhi
Central
DELHI 		 9654700952

dr_rekhagupta@yahoo.co.in 
 
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: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Classic Shade guide group   All ceramic crowns fabricated using shade recorded by classic Shade guide on the day of crown delivery  
Intervention  Digital Camera Group   All ceramic crowns fabricated using shade recorded by digital camera on the day of crown delivery  
Intervention  Digital Shade guide group   All ceramic crowns fabricated using shade recorded by digital Shade guide on the day of crown delivery 
Comparator Agent  Healthy adjacent tooth  Shade of healthy adjacent tooth recorded on the day of delivery 
Intervention  Smartphone group   All ceramic crowns fabricated using shade recorded by smartphone on the day of crown delivery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patient with maxillary anterior tooth requiring FPD.
2. Teeth that presented an unaltered reference adjacent natural tooth 
 
ExclusionCriteria 
Details  1. Patient with missing adjacent teeth
2. Patient with severe discoloration 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To measure magnitude of color
difference between crown fabricated and reference
tooth at time of crown delivery 		 To compare the shade selection accuracy using
classic shade guide, digital camera, smartphone and
digital shade guide for anterior all ceramic crown.
The primary outcome is to measure magnitude of color
difference between crown fabricated and reference
tooth. 
 
Secondary Outcome  
Outcome  TimePoints 
To study the accuracy of recording the shade for all ceramic crown using classic shade guide, digital shade guide, smart phone and digital camera  At the time of delivery of crown 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   15/03/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
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 - NO
Brief Summary  

This study is a randomized, single blind, parallel group trial comparing the shade selection accuracy using classic shade guide, digital camera, smartphone and digital shade guide for anterior all ceramic crown. The primary outcome is to measure magnitude of color difference between crown fabricated and reference tooth.

 
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