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CTRI Number  CTRI/2025/03/083398 [Registered on: 25/03/2025] Trial Registered Prospectively
Last Modified On: 21/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Tooth shade selection using visual and smartphone method. 
Scientific Title of Study   Comparative evaluation and discrepancy in the tooth shade selection using conventional visual method and smartphone method- A prospective observational 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 LAVANYA PRAKASH 
Designation  MDS (Postgraduate student) 
Affiliation  I.T.S. DENTAL COLLEGE, GREATER NOIDA 
Address  Room no.7, Department of Conservative dentistry and Endodontics, I.T.S. DENTAL COLLEGE, Knowledge park 3, Greater Noida 47

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9082072401  
Fax    
Email  lavanya.mds24@its.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr MANJU KUMARI 
Designation  Professor 
Affiliation  I.T.S. DENTAL COLLEGE HOSPITAL, GREATER NOIDA 
Address  Room no.7, Department of Conservative dentistry and Endodontics, I.T.S. DENTAL COLLEGE, Knowledge park 3, Greater Noida 47

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9811056881  
Fax    
Email  manjukumari.dntl.gn@its.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr LAVANYA PRAKASH 
Designation  MDS (Postgraduate student) 
Affiliation  I.T.S. DENTAL COLLEGE HOSPITAL, GREATER NOIDA 
Address  Room no.7, Department of Conservative dentistry and Endodontics, I.T.S. DENTAL COLLEGE, Knowledge park 3, Greater Noida 47

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9082072401  
Fax    
Email  lavanya.mds24@its.edu.in  
 
Source of Monetary or Material Support  
Room no.7, Department of Conservative dentistry and Endodontics, I.T.S. DENTAL COLLEGE, Knowledge park 3, 201310, Greater Noida 47, uttar pradesh, india 
 
Primary Sponsor  
Name  ITS Dental College Hospital and Research Centre  
Address  Room no.7, Department of Conservative dentistry and Endodontics, I.T.S. DENTAL COLLEGE, Knowledge park 3, Greater Noida 47, Uttar Pradesh, India  
Type of Sponsor  Research institution and hospital 
 
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 LAVANYA PRAKASH  I.T.S. DENTAL COLLEGE, GREATER NOIDA  Room no.7, Department of Conservative dentistry and Endodontics, I.T.S. DENTAL COLLEGE, Knowledge park 3, Greater Noida 47
Gautam Buddha Nagar
UTTAR PRADESH 		 9082072401

lavanya.mds24@its.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
I.T.S Dental college hospital and research centre institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K049||Other and unspecified diseases ofpulp and periapical tissues,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Adult patients aged between 18-50 years.
2.Patients undergoing crown post-endodontic treatment.
3.Patients undergoing smile designing treatment using Composite/Ceramic, Crown/Veneer.
 
 
ExclusionCriteria 
Details  1.Intrinsic Stains
2.Teeth with crowns and veneers.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the shade selection by visual method using 3D Master VITA Shade Guide and smartphone photography using Adobe photoshop CC.
 		 shade selection will be evaluated at baseline.
 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the shade selection by visual method using 3D Master VITA Shade Guide & smartphone photography using Adobe photoshop CC.  Shade selection will be compared at baseline. 
 
Target Sample Size   Total Sample Size="172"
Sample Size from India="172" 
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)   05/04/2025 
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="1"
Months="0"
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   172 patients will be selected according to inclusion and exclusion criteria from the OPD of department of conservative dentistry and endodontics

Group A- Visual method- Selected shade’s CIE L* a* b* will then be recorded from the table.
Group B- Digital Photography (Vita 3D Master)- The CIE L* a* b* of the photograph will be obtained by image analyzing software (Adobe Photoshop CC)

Reading obtained of CIE L* a* b* by different method will be then compiled systematically into excel sheets.

The comparison and difference in shades of Visual and Smartphone method will then be subjected to appropriate statistical ananlysis.

 
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