| CTRI Number |
CTRI/2026/01/101398 [Registered on: 16/01/2026] Trial Registered Prospectively |
| Last Modified On: |
12/07/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the efficiency of shade selection done for gums by a web-based application on single-unit metal ceramic crowns. |
|
Scientific Title of Study
|
Evaluation of the clinical performance of a web-based gingival shade guide on single-unit metal ceramic crown: A clinical trial |
| 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 Aishwarya A Nair |
| Designation |
PG student |
| Affiliation |
KSR Institute of Dental Science and Research |
| Address |
Department of Prosthodontics – Postgraduate section,
Room No. 4,
KSR Institute of Dental Science and Research,
Tiruchengode.
Namakkal
TAMIL NADU
637215
India |
| Phone |
9566351887 |
| Fax |
|
| Email |
dr.aishwaryaooty@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Vidhyasankari N, MDS, PhD, FIAOI |
| Designation |
Professor & Head of the Department |
| Affiliation |
KSR Institute of Dental Science and Research |
| Address |
Department of Prosthodontics ,
Room No. 4,
KSR Institute of Dental Science and Research,
Tiruchengode.
Namakkal
TAMIL NADU
637215
India |
| Phone |
9443940244 |
| Fax |
|
| Email |
vidhya_3010@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aishwarya A Nair |
| Designation |
PG student |
| Affiliation |
KSR Institute of Dental Science and Research |
| Address |
Department of Prosthodontics ,
Room No. 4,
KSR Institute of Dental Science and Research,
Tiruchengode.
Namakkal
TAMIL NADU
637215
India |
| Phone |
9566351887 |
| Fax |
|
| Email |
dr.aishwaryaooty@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Aishwarya A Nair |
| Address |
KSR Kalvi Nagar,
Kuchipalayam (PO), Tiruchengode - 637215,
Namakkal District,
Tamil Nadu,
India |
| 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 Aishwarya A Nair |
KSR Institute of Dental Science and Research |
Department of Prosthodontics – Postgraduate section,
Room No. 4,
KSR Institute of Dental Science and Research,
Tiruchengode.
Namakkal
TAMIL NADU |
9566351887
dr.aishwaryaooty@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KSRIDSR INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K060||Gingival recession, (2) ICD-10 Condition: K08||Other disorders of teeth and supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Gingival shade guide |
Conventional gingival shade guide (Ivoclar gingival shade guide - i emax - Ceram). The intervention will be done 1 time for each patient |
| Intervention |
Web application |
An artificial intelligence-based web application named G shade wizard for gingival shade selection. The intervention will be done 1 time for each patient. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants having gingival recession according to Cairo’s classification RT1 and RT2
2. Participants in need of single unit crowns in either maxilla / mandible
3. Participants in need of metal ceramic restorations for both vital and non-vital teeth
|
|
| ExclusionCriteria |
| Details |
1. Participants having no recession or recession other than RT1 and RT2
2. Participants requiring multiple unit bridges
3. Participants requiring restorations other than metal ceramic restorations
4. Participants who do not need replacement of the gingival tissue
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Esthetic assessment by the participant and by 3 observers. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "15"
Final Enrollment numbers achieved (India)="15" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/01/2026 |
| Date of Study Completion (India) |
31/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This prospective clinical trial evaluated a web-based gingival shade selection application against the conventional visual shade selection method in 15 patients requiring single-unit metal ceramic crowns with gingival-colored porcelain. Gingival shade was determined using both methods, and the esthetic outcomes were assessed by two blinded prosthodontists and the patients using a 10-point Visual Analog Scale. The web-based application demonstrated significantly better esthetic performance, with improved reliability and consistency compared with the conventional method. These findings suggest that the application is a reliable, accessible, and cost-effective tool for enhancing gingival shade selection in prosthodontic practice. |