| CTRI Number |
CTRI/2025/10/095662 [Registered on: 06/10/2025] Trial Registered Prospectively |
| Last Modified On: |
03/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Pre & Post Interventional] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Lupin Dental smile designing India Study |
|
Scientific Title of Study
|
Prospective, open-label, interventional pivotal study to evaluate the safety of the Lupin robotic system in tooth preparation for veneer procedures in adult patients |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| REG04-001 R-03 |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Thiyaneswaran N |
| Designation |
Professor BDS MDS (Prosthodontics) PhD |
| Affiliation |
Saveetha Dental college &Hospital |
| Address |
Saveetha Dental College and Hospitals 162 Poonamalle High Rd Velappanchavadi Chennai Tamil Nadu 600077
Chennai
TAMIL NADU
600077
India |
| Phone |
09884176432 |
| Fax |
|
| Email |
thiyaneswaran@saveetha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Thiyaneswaran N |
| Designation |
Professor BDS MDS (Prosthodontics) PhD |
| Affiliation |
Saveetha Dental college &Hospital |
| Address |
Saveetha Dental College and Hospitals 162 Poonamalle High Rd Velappanchavadi Chennai Tamil Nadu 600077
Chennai
TAMIL NADU
600077
India |
| Phone |
09884176432 |
| Fax |
|
| Email |
thiyaneswaran@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Thiyaneswaran N |
| Designation |
Professor BDS MDS (Prosthodontics) PhD |
| Affiliation |
Saveetha Dental college &Hospital |
| Address |
Saveetha Dental College and Hospitals 162 Poonamalle High Rd Velappanchavadi Chennai Tamil Nadu 600077
Chennai
TAMIL NADU
600077
India |
| Phone |
09884176432 |
| Fax |
|
| Email |
thiyaneswaran@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College and Hospitals 162 Poonamalle High Rd Velappanchavadi Chennai Tamil Nadu 600077
|
|
|
Primary Sponsor
|
| Name |
Lupin Dental |
| Address |
2040 AVENUE DU PERE SOULAS MONTPELLIER Pin 34000 France |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 Thiyaneswaran N |
Saveetha Dental College & Hospital |
Department of prosthodontics, Saveetha Dental College and Hospitals 162 Poonamalle High Rd Velappanchavadi Chennai Tamil Nadu 600077
Chennai
TAMIL NADU |
09884176432
thiyaneswaran@saveetha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Dental College & Hospital Institutional Ethics Committee (SDC-IHEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, , (1) ICD-10 Condition: K085||Unsatisfactory restoration of tooth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
Pre-Post Intervention |
Pre Interventional - Intraoral scan images with imaging system and with the Lupin gauge performed by the dentist (standard of care when imaging without Lupin Gauge) Post Interventional - Acquisition of the post-interventional patients image with an intra-oral scan before the temporary veneer placement and before any potential adjustments if adjustments is performed, acquisition of an additional post-interventional patient’s image with an intra-oral scan. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Male or female patient between 18 and 75 years
2.Patient foreseen to receive one or more veneer upon dentist recommendation
3.Patient who agrees to participate in the study and who has signed the informed
consent
4.Natural healthy neighboring teeth without need of restorations
5.No need of conservative dental care |
|
| ExclusionCriteria |
| Details |
6.Any medical condition constituting, in the judgement of the investigator and per product Use Manual a contraindication to the dental treatment itself
7.Impossibility to perform the intraoral scan with the Lupin Dental gauge (e.g.maximum opening of the jaws too small)
8.Presence of a brace or any dental apparatus
9.Presence of indirect restoration on one or several teeth to treat
10.Any medical condition leading to uncontrolled movements (e.g. Parkinsons disease)
11.Cases that require a sub-gingival margin lines definition (e.g. serious dyschromia of the root or of the tooth)
12.Requirements for dental treatments that could impact margin lines definition (e.g. cavities in the cervical line)
13.moderate or severe dental malposition which may result in dentin exposure during preparation of more than 20% of the vestibular surface
14.enamelstructuraldefect(amelogenesis/dentinogenesis imperfecta)
15.Pregnant or breast-feeding person, the former attested by an over-the-counter urinary test provided by the sponsor
16.Uncontrolled diabetes
17.Recent chemotherapy (during the 6 months prior to inclusion into the study)
18.Long-term use of drugs influencing bone or soft tissue healing (e.g.high doses of antiresorptive medication, steroids or anti-inflammatory drugs)
19.Additional oral surgery planned to be conducted in the region of interest
20.Not enough teeth to allow a splint rigidity
21.Teeth instability that do not allow splint rigidity
22.Presence of parafunctions
23.Inadequate oral hygiene as estimated by the investigator
24.Female of childbearing potential uncompliant to an adequate contraceptive method
25.Patients with a high enamel erosion that could lead to too much dentine exposure
26.Patients unsure of wanting a veneer procedure or unsure of a final mock-up choice
27.Patients unable to comprehend or to sign freely a study consent, patients under legal protection, guardianship or tutorship, patients interned in a psychiatric institution residents of judiciary institutions
28.Patients currently in the exclusion period of another interventional clinical trial or having participated in another clinical trial within a month prior to inclusion into
the present trial |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
-Enamel surface preservation/dentine exposure
-preparation margins clarity- tooth preparation which respects convexity
-homogenous space between the prepared tooth and temporary tooth (i.e.
appropriate thickness of the veneer)
-presence of butt margin at the incisal edge. |
Visit 1 - Initial Visit
Visit 2 - Mock up and PSS validation visit
Visit 3 - Procedure day
Visit 4 - Post Procedure visit
Visit 5 - Additional Post Procedure visit
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| A quantitative analysis on the prepared teeth will be performed to compute the error between the surface of the prepared tooth & the surface of the plannedtooth.A descriptive analysis will be done on the error metrics to define the best quantitative criteria defining minimally invasive preparations.The analysis will be used to inform future clinical studies. |
Visit 1 - Initial Visit
Visit 2 - Mock up & PSS validation visit
Visit 3 - Procedure day
Visit 4 - Post Procedure visit
Visit 5 - Additional Post Procedure visit
|
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/10/2025 |
| 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="4"
Days="15" |
|
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
|
Prospective, open-label, interventional, study to evaluate the safety and the
performance of the Lupin robotic system in tooth preparation for veneer procedures in
adult patients. The primary objective of the study is: The evaluation of the performance of the Lupin robotic system for dental veneer preparation as assessed by visual analysis according to the silicon index methodology and photographic analyses of the prepared tooth surface with respect to global preparation acceptability and enamel preservation The secondary objectives are: Safety assessment of the Lupin robotic system in tooth preparation for veneer dental procedures. Assessment of each individual performance endpoint that justifies the global performance assessment under the primary endpoint, namely : extent of enamel surface preservation/dentine exposure, preparation margins clarity, tooth preparation convexity, homogenous space between prepared tooth and temporary tooth, presence of butt margin at the incisal edge. The following additional information will be collected : number of significant adjustments required, procedure and treatment duration. Assessment of the ease of use by the operating investigator of the Lupin robotic system. Patient acceptability assessment for treatment using the Lupin robotic system. Final veneer fit assessment on the prepared tooth. Funtional integration of final veneer after the bonding procedures |