| CTRI Number |
CTRI/2025/07/089996 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
05/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Shade Selection of Teeth Using Visual Method, DSLR Camera and a Smartphone Camera and Comparing The Results In a Software. |
|
Scientific Title of Study
|
Comparison of Shade Selection of Maxillary Central Incisor by Visual Method, DSLR Camera and a Smartphone Camera Using a Shade Analysis Software: 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 |
Khushi Sonawane |
| Designation |
MDS Student |
| Affiliation |
Manubhai Patel Dental College |
| Address |
Department of Prosthodontics, crown and bridge including implantology, Manubhai Patel Dental College and Hospital, Nr Vishwajyoti Ashram, Muj Mahuda, Vadodara, Gujarat
Vadodara
GUJARAT
390011
India |
| Phone |
6353877468 |
| Fax |
|
| Email |
khushisonawane08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonal Mehta |
| Designation |
Head of Department, Department Of Prosthodontics |
| Affiliation |
Manubhai Patel Dental College and Hospital |
| Address |
Department of Prosthodontics, Crown and Bridge including Implantology, Manubhai Patel Dental College and Hospital, Nr Vishwajyoti Ashram, Muj Mahuda, Vadodara, Gujarat, India 390011
Vadodara
GUJARAT
390011
India |
| Phone |
9428974820 |
| Fax |
|
| Email |
docsonalmehta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonal Mehta |
| Designation |
Head of Department, Department Of Prosthodontics |
| Affiliation |
Manubhai Patel Dental College and Hospital |
| Address |
Department of Prosthodontics, Crown and Bridge including Implantology, Manubhai Patel Dental College and Hospital, Nr Vishwajyoti Ashram, Muj Mahuda, Vadodara, Gujarat, India 390011
Vadodara
GUJARAT
390011
India |
| Phone |
9428974820 |
| Fax |
|
| Email |
docsonalmehta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Prosthodontics, Crown and Bridge including Implantology, Manubhai Patel Dental College and Hospital, Nr. Vishwajyoti Ashram, Vadodara, Gujarat, India 390011 |
|
|
Primary Sponsor
|
| Name |
Dr Khushi Sonawane |
| Address |
Satyam A-1201, Sai Shukan Residency, Rajmahal Road, Vadodara 390001 |
| 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 Khushi Sonawane |
Manubhai Patel Dental College |
Department of Prosthodontics crown and bridge including implantology, Manubhai Patel Dental College, Nr Vishwajyoti Ashram, Muj Mahuda, Vadodara
Vadodara
GUJARAT |
6353877468
khushisonawane08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) for Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
People with a Complete set of Maxillary anterior teeth and good oral hygiene |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with complete set of maxillary anterior teeth
Subjects with good oral hygiene
Subjects willing to participate in the study |
|
| ExclusionCriteria |
| Details |
The anterior teeth should be void of caries, restorations,
endodontic treatments, fluorosis, calcifications,
hypoplasia, trauma, and any factor that may cause
discoloration of the teeth. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the shade selection for maxillary central
incisor using visual method and matching it with the
standardized shade value chart.
2. To evaluate the shade selection using a DSLR camera picture on the digital
software and matching it with the standardized shade
value chart.
3. To evaluate the shade selection using a smart phone camera picture on the
digital software and matching it with the standardized
shade value chart. |
End of all data collection, i.e 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the shade matching for maxillary central
incisor with visual method, DSLR camera and
smartphone camera. |
End of all data collection, i.e 1 Year |
|
|
Target Sample Size
|
Total Sample Size="243"
Sample Size from India="243"
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)
|
15/09/2025 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Shade tabs and patient teeth will be analysed visually and digitally. Each Vita 3D-Master shade tab will be photographed next to an 18% gray card in controlled lighting to record baseline CIELAB values. Patients sitting in the same lighting will be visually assessed using the vita guide. Standardised digital photographs will be taken with a DSLR camera and an iPhone 16 with fixed parameters. The image will be imported in the software, color cast will be removed and converted to LAB space. The central incisor area will be selected and its digital LAB values will be recorded and normalised to CIELAB scale. The difference will be computed to compare the various methods. |