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.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Visit 1 - Initial Visit
研究概览
简要总结
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
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
- •â€¢ 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.
- •â€¢ No need of conservative dental care.
排除标准
- •Exclusion Criteria • Any medical condition constituting, in the judgement of the investigator and per product Use Manual, a contraindication to the dental treatment itself.
- •â€¢ 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.
结局指标
主要结局
Visit 1 - Initial Visit
时间窗: 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
Visit 2 - Mock up and PSS validation visit
时间窗: 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
Visit 3 - Procedure day
时间窗: 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
Visit 4 - Post Procedure visit
时间窗: 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
Visit 5 - Additional Post Procedure visit
时间窗: 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
次要结局
- 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.)
研究者
Dr Vijaysinh Abhayrao More
Institute (Bharti Vidyapeeth Deemed to be University Dental College and Hospital)