Health Condition 1: - Health Condition 2: - Health Condition 3: K085- Unsatisfactory restoration of tooth
Conditions
Interventions
Intervention1: 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 Gaug
Sponsors
Lupin Dental
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -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. Timepoint: 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
| Measure | Time frame |
|---|---|
| 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.Timepoint: 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 | — |
Countries
India
Contacts
Public ContactDr Thiyaneswaran N
Saveetha Dental college &Hospital
Outcome results
None listed