| CTRI Number |
CTRI/2025/06/088771 [Registered on: 13/06/2025] Trial Registered Prospectively |
| Last Modified On: |
11/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Is visual shade selection better than digital |
|
Scientific Title of Study
|
The Spectral Showdown- Comparative evaluation of different tooth shade systems in aesthetic dentistry |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohil Kale |
| Designation |
PG Student |
| Affiliation |
College Of Dental Sciences And Research Center |
| Address |
Room No. 7, Department of Conservative Dentistry and Endodontics, College Of Dental Sciences And Research Center, Manipur, Ghuma, Ahmedabad
Ahmadabad
GUJARAT
380058
India |
| Phone |
9726817619 |
| Fax |
|
| Email |
mohilkale@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nishtha Patel |
| Designation |
Professor and PG Guide |
| Affiliation |
College Of Dental Sciences And Research Center |
| Address |
Room No. 7, Department of Conservative Dentistry and Endodontics, College Of Dental Sciences And Research Center, Manipur, Ghuma, Ahmedabad
Ahmadabad
GUJARAT
380058
India |
| Phone |
9712994610 |
| Fax |
|
| Email |
dr.nkp.2557@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nishtha Patel |
| Designation |
Professor and PG Guide |
| Affiliation |
College Of Dental Sciences And Research Center |
| Address |
Room No. 7, Department of Conservative Dentistry and Endodontics, College Of Dental Sciences And Research Center, Manipur, Ghuma, Ahmedabad
GUJARAT
380058
India |
| Phone |
9712994610 |
| Fax |
|
| Email |
dr.nkp.2557@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Conservative Dentistry and Endodontics, College Of Dental Sciences And
Research Center, Ghuma, Ahmedabad, Gujarat, India- 382115 |
|
|
Primary Sponsor
|
| Name |
Mohil Kale |
| Address |
Room No. 7, Department of Conservative Dentistry and Endodontics,College Of Dental Sciences And Research Center, Manipur, Ghuma,Ahmedabad, Gujarat,India- 382115 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mohil Kale |
College of Dental Sciences and Research center |
Room No.7,
Department of Conservative Dentistry And Endodontics,
College of Dental Sciences And Research Center, Manipur, Near Bopal
Ahmadabad
GUJARAT |
9726817619
mohilkale@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, College Of Dental Sciences And Research Center |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K037||Posteruptive color changes of dental hard tissues, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intraoral scanner |
Digital shade selection using intraoral scanner |
| Intervention |
VITA Shade guide |
Visual shade selection using VITA shade guide in ambient light for 5 seconds |
| Comparator Agent |
VITA Shade guide |
Visual shade selection using VITA shade guide in white light for 5 seconds |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients with clinically normal maxillary anterior teeth and good oral hygiene between the age of 20 to 40 years will be selected |
|
| ExclusionCriteria |
| Details |
1. Extensively carious teeth
2. Periodontally damaged teeth
3. Restored teeth
4. Teeth with mineralization disorders
5. Recently bleached teeth
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Significant difference in between all the three groups |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No significant difference in all 3 groups |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
26/06/2025 |
| 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="3"
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
|
Aim:-
To compare visual shade selection using a
shade guide to digital method of shade selection for in vivo shade matching
Materials
and methodology:-
A total of
10 patients will be taken with clinically normal maxillary central incisors and
good oral hygiene.
The incisors
will be cleaned and then inspected under white light and ambient light
respectively by using VITA classical shade guide (A1-D4) by a novice
dentist, followed by an experienced dentist. This will be followed by shade
matching using digital methods involving use of intraoral scanner for the same
set of teeth. Each approach will be focused on the middle third of the tooth
for shade selection.
The data
from all the groups will be recorded and sent for statistical analysis. |