| CTRI Number |
CTRI/2024/12/078781 [Registered on: 31/12/2024] Trial Registered Prospectively |
| Last Modified On: |
07/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
LUPIN Dental VENEER India study |
|
Scientific Title of Study
|
Prospective, open-label, interventional, investigator initiated study to evaluate the
safety and the performance of the Lupin robotic system in tooth preparation for veneer
procedures in adult patients.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol Number R01 dated 12 Oct 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vijaysinh Abhayrao More |
| Designation |
BDS MDS PG Dip (Implantology) |
| Affiliation |
Institute (Bharti Vidyapeeth Deemed to be University Dental College and Hospital) |
| Address |
206 Dept of Prosthodontics Crown and Bridge Implantology Bharati Vidyapeeth Deemed to be University Dental College and Hospital Katraj Dhankawadi complex Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
02024373266 |
| Fax |
|
| Email |
vijaysinh.more1@bharatividyapeeth.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manisha Jadhav |
| Designation |
Study Manager |
| Affiliation |
Indical Medsurg Pvt Ltd |
| Address |
A/4 Ground floor Parle Colony Sahakar Road Near Nobale Medical
Vile Parle (East) Mumbai
Mumbai
MAHARASHTRA
400057
India |
| Phone |
9623243509 |
| Fax |
|
| Email |
manisha@indicalmed.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manisha Jadhav |
| Designation |
Study Manager |
| Affiliation |
Indical Medsurg Pvt Ltd |
| Address |
A/4 Ground floor Parle Colony Sahakar Road Near Nobale Medical
Vile Parle (East) Mumbai
Mumbai
MAHARASHTRA
400057
India |
| Phone |
9623243509 |
| Fax |
|
| Email |
manisha@indicalmed.com |
|
|
Source of Monetary or Material Support
|
| Name of Hospital:
Bharati Vidyapeeth Dental College & Hospital
Complete Address: 206, Dept of Prosthodontics, Crown & Bridge, Implantology Bharati Vidyapeeth Deemed to be University Dental College & Hospital Katraj Dhankawadi complex, Pune 411043 PH: 02024373266
|
|
|
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
|
| Name |
Address |
| Dolphin Lifescience India LLP |
Survey No 133/1, Moje Dhamdod,
Taluka – Mangrol, DIst – Surat
Gujrat, India 394125 |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vijaysinh Abhayrao More |
Bharati Vidyapeeth Dental College & Hospital |
206, Dept of Prosthodontics, Crown & Bridge, Implantology Bharati Vidyapeeth Deemed to be University Dental College & Hospital Katraj Dhankawadi complex, Pune
Pune
MAHARASHTRA |
9881494599
vijaysinh.more1@bharatividyapeeth.edu |
| Dr Thiyaneswaran N |
Saveetha Dental College and Hospitals |
Saveetha Dental College and Hospitals, 162, Poonamalle High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077
Chennai
TAMIL NADU |
9884176432
thiyaneswaran@saveetha.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Bharti Viyapeeth Deemed University |
Approved |
| 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 |
| 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 patient’s
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 |
• Male or female patient between 18 and 75 years,
• Patient foreseen to receive one or more veneer, upon dentist recommendation,
• Patient who agrees to participate in the study and who has signed the informed
consent,
• Natural healthy neighboring teeth without need of restorations.
• No need of conservative dental care. |
|
| ExclusionCriteria |
| Details |
Exclusion Criteria
• Any medical condition constituting, in the judgement of the investigator and per product Use Manual, a contraindication to the dental treatment itself.
• Impossibility to perform the intraoral scan with the Lupin Dental gauge (e.g.
maximum opening of the jaws too small)
• Presence of a brace or any dental apparatus
• Presence of indirect restoration on one or several teeth to treat
• Any Medical conition leading to uncontrolled movements (e.g. Parkinson disease)
• Pregnant or breast-feeding person, the former attested by an over-the-counter urinary test provided by the sponsor
• Uncontrolled diabetes
• Recent chemotherapy (during the 6 months prior to inclusion into the study),
• Use of drugs influencing bone or soft tissue healing (e.g. high doses of antiresorptive medication, steroids or anti-inflammatory drugs)
• Additional oral surgery planned to be conducted in the region of interest
• Not enough teeth to allow a splint rigidity
• Teeth instability that do not allow splint rigidity
• Presence of parafunctions
• Inadequate oral hygiene as estimated by the investigator
• Female of childbearing potential uncompliant to an adequate contraceptive method
• Patients with a high enamel erosion that could lead to too much dentine exposure
• Patients unsure of wanting a veneer procedure or unsure of a final mock-up choice
• 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
• Patients currently in the exclusion period of another 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
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
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 |
Visit 1 - Initial Visit Pre Intervention consultation D0 to 3 weeks +/-1 week
Visit 2 - Mock up and PSS Validation (D0-2 weeks) +/- 1 week)
Visit 3 - Procedure day D0
Visit 4 - Post Procedure visit D7 to D14
Visit 5 - Additional Post Procedure visit D15 to D30
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Safety:
Number & frequency of occurrence of Adverse Events (AEs), Serious Adverse Events (SAEs), Device Deficiencies (DDs),eventual serious health hazards, both anticipated & unanticipated (UAE, USADE), related (ADEs, SADEs) & unrelated (AEs, SAEs) to the tooth preparation for veneer treatment using the Lupin robotic system, as relates to the device itself or to the procedure during which it is used. |
Ease of Use :
• User Satisfaction questionnaire filled by operating investigator.
Patient Acceptability
• Comfort with the LUPIN robotic system procedure as assessed by patient
(Visual Analogy Scale 0 to 10)
• Cooperation of patient during the procedure as assessed by investigator (Visual Analogy Scale 0 to 10) |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "21"
Final Enrollment numbers achieved (India)="21" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
13/01/2025 |
| Date of Study Completion (India) |
30/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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, investigator initiated 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 |