Health Condition 1: K085- Unsatisfactory restoration of tooth
Conditions
Interventions
Intervention1: Pre-interventional & Post Interventional: 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 befo
(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 befo
Sponsors
LUPIN DENTAL
Dolphin Lifescience India LLP
Eligibility
Inclusion criteria
Inclusion criteria: ? 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 visitTimepoint: 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
| Measure | Time frame |
|---|---|
| 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.Timepoint: 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) | — |
Countries
India
Contacts
Public ContactDr Manisha Jadhav
Indical Medsurg Pvt Ltd
Outcome results
None listed