| CTRI Number |
CTRI/2025/07/090594 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
05/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing AI-based and conventional digital smile design in adult dental patients receiving Veneers |
|
Scientific Title of Study
|
Multicentre Randomized Controlled Trial of AI-driven Digital Smile Design vs Conventional Digital Wax-up: Measuring 3-Year Veneer Survival, Color Stability and Cost-Utility |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sagar Abichandani |
| Designation |
Director |
| Affiliation |
Silverline Dent and Care Solutions Pvt. Ltd |
| Address |
silverline Dent and Care Solutions Pvt Ltd.
Ashiyana,105B, 1st floor, sindhi society, chembur east.
Mumbai
MAHARASHTRA
400071
India |
| Phone |
9819700729 |
| Fax |
|
| Email |
sagar.abichandani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sagar Abichandani |
| Designation |
Director |
| Affiliation |
Silverline Dent and Care Solutions Pvt. Ltd |
| Address |
silverline Dent and Care Solutions Pvt Ltd.
Ashiyana,105B, 1st floor, sindhi society, chembur east.
Mumbai
MAHARASHTRA
400071
India |
| Phone |
9819700729 |
| Fax |
|
| Email |
sagar.abichandani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sagar Abichandani |
| Designation |
Director |
| Affiliation |
Silverline Dent and Care Solutions Pvt. Ltd |
| Address |
silverline Dent and Care Solutions Pvt Ltd.
Ashiyana,105B, 1st floor, sindhi society, chembur east.
Mumbai
MAHARASHTRA
400071
India |
| Phone |
9819700729 |
| Fax |
|
| Email |
sagar.abichandani@gmail.com |
|
|
Source of Monetary or Material Support
|
| this is an investigator- initiated, self funded study. silver line dent and care solutions put ltd provided all funding and material support. |
|
|
Primary Sponsor
|
| Name |
Silverline Dent and Care Solutions Pvt Ltd |
| Address |
ashiyana, 105B, 1st floor, Sindhi society, Chembur east,mumbai 400071 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| sagar abichandani |
silverline dent and care solutions pvt ltd |
ashiyana, 105B, 1st floor, Sindhi society, Chembur , Mumbai 400071
Mumbai
MAHARASHTRA |
9819700729
sagar.abichandani@gmail.com |
| dr amrita pandita |
YCDC, ahilyanagar |
166 1 , vadgaon Gupta, opposite MIDC, ahilyanagar . 414003.
Ahmadnagar
MAHARASHTRA |
7300050333
pandita.amrita@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| silverline institutional review board |
Approved |
| YCDC ahilyanagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Aesthetic dental concerns related to anterior teeth without systemic illness |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AI driven digital smile design |
participants in this group underwent treatment planning using artificial intelligence based digital smile design software that utilised facial analysis, dental arch scans, and dynamic smile recording. veneers were fabricated based on digitally generated mock ups and final restorations were delivered as per virtual design. |
| Comparator Agent |
conventional digital wax up |
paticipants in this group were treated using conventional analog or manual digital wax up protocols for smile design. tooth preparation and veneer fabrication were based on static wax patterns without AI based smile simulation. all prosthesis were delivered as per standard protocols. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
systemically healthy adults aged 18-55 years.
requirements for 4-8 maxillary anterior veneers for aesthetic reasons.
no prior restorations on anterior teeth in aesthetic zone.
good periodontal health.
singed informed consent obtained |
|
| ExclusionCriteria |
| Details |
presence of parafunctional habits.
smokers or tobacco users.
history of trauma or root canal therapy in anterior teeth.
pregnant or lactating mothers.
poor oral hygiene or untreated periodontal disease.
allergies to ceramic materials or bonding agents. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 3 year clinical survival of anterior ceramic veneers ( measured by absence of debonding, fracture or loss) |
3 year clinical survival of anterior ceramic veneers ( measured by absence of debonding, fracture or loss) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| colour stability of veneers ( measured with spectrophotometer ) |
at final review ( 36 months) |
| patient satisfaction score using VAS ( visual analogue scale) |
at final review ( 36 months) |
| oral health impact profile ( OHIP-14 aesthetic sub scale improvement) |
pre treatment and 36 months post treatment |
| incremental cost utility ratio ( ICUR) per satisfaction point gained |
at final review ( 36 months) |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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)
|
21/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
21/07/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="4"
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
|
this multicentre randomised controlled trial compared the clinical performance , colour stability and cost utility of AI-driven digital smile design (DSD) versus conventional digital wax for anterior ceramic veneers. a total of 76 patients were enrolled across two sties in Mumbai and Ahmednagar . participants were followed for 36 months post treatment to evaluate veneer survival, aesthetic stability , patient satisfaction, and quality of life improvement using OHIP-14. the trial concluded in June 2025 and demonstrated comparable veneer survival in both groups with significantly higher patient satisfaction and cost effectiveness in the AI-DSD group. |