Prospective, open-label, interventional pivotal study to evaluate the safety of the Lupin robotic system in tooth preparation for veneer procedures in adult patients

Lupin Dental1 个研究点分布在 1 个国家目标入组 45 人开始时间: 2025年10月15日最近更新: 2025年10月3日

试验速览

阶段: 4 期
状态: 尚未招募
发起方
入组人数: 45
试验地点: 1
主要终点: -Enamel surface preservation/dentine exposure

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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

研究设计

研究类型: Interventional
分配方式: Na
盲法: None

入排标准

年龄范围: 18.00 Year(s) 至 75.00 Year(s)（—）
性别: All

入选标准

•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.

排除标准

•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.