Medico-economic Comparative Assessment of Conventional and CAD/CAM Dental Restorations; Impact on Hospital Dentistry Departments
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- efficiency (derived from differences in efficacy, safety and costs)
研究概览
简要总结
Dental restorations (crowns, inlays or onlays) can be made conventionally or by CAD/CAM. The current literature is weak and does not separate the medical results of these two techniques. However, the efficiencies enabled by CAD/CAM could, for the price of an initial investment, improve service to the patient by reducing the time required for these restorations, and possibly lower care costs.
The aim of the study is to compare immediate medical results and short-term prosthetic restorations made conventionally or by CAD/CAM in randomized patients, and evaluate economic impacts and organizational aspects.
详细描述
The medico-economic objective of this study is to assess an organizational innovation for patients treated at the hospital for dental substance loss. The intervention study is the availability of such information for the management of patients, not that of its systematic use.
The economic evaluation of this innovation consists of several parts:
- A costing study seeking to determine the costs of compensation for dental substance loss by conventional technique and CAD/CAM per patient ;
- Evaluate the cost from an hospital perspective to substitute CAD/CAM to conventional dental treatment equipments;
- To built a cost-effectiveness ratio comparing the conventional technique and the CAD/CAM on the criterion of proportions of effective restorations obtained .
Assess the medical and medico-technical impact of prosthesis availability from CAD/CAM:
Modifications of treatment plans (some indications of plastic fillings could shift toward CD/CAM restorations?) and/or their chronology (order of execution phases).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is cared for in a hospital department of Dentistry for oral rehabilitation.
- •The patient has a dental insurance plan
- •There is indication of at least a partial or total dental crown, either by conventional methods or by CAD/CAM ( equipoise clause) .
- •It is possible to follow the patient for at least 6 months ( mid-term outcome evaluation beyond the immediate outcome)
- •Assessment of the patient to this monitoring (formal informed consent is not required by French law for accepted procedures)
排除标准
- •mental , linguistic or legal impossibility of understanding the protocol or no consent to participation.
- •Follow-up impossible or doubtful
- •Contraindication whatsoever to any therapeutic that can be implemented:
- •bruxism and occlusion disorders requiring treatment ( mechanical stresses , ceramic contra-indicated )
- •TMJ disorder (severe limitation of therapeutic options before resolution)
- •known intolerance to a dental material used in the study
- •Patients participating in another clinical trial that may have an impact on the oro-facial region (consultation with investigators in the other trial is required before selection and inclusion).
- •Need for further prosthetic development (e. g. telescopic milled crown ) .
- •Extensive coronary reconstruction requiring de novo root anchorage (post-and-core)
研究组 & 干预措施
1
CAD/CAM manufactured fixed unitary dental prostheses
干预措施: CAD/CAM manufactured fixed unitary dental prostheses (Device)
2
Conventionally manufactured unitary dental prostheses
干预措施: Conventionally manufactured unitary dental prostheses (Device)
结局指标
主要结局
efficiency (derived from differences in efficacy, safety and costs)
时间窗: 18 months
Differential efficiency (derived from differences in efficacy, safety and costs) at end of treatment.
次要结局
- patient satisfaction on the VAS scale(18 months)
- occurrence of adverse effects(18 months)
- quality of life measured by SF36(18 months)
- Costs(18 months)
- observance (number of visits/number of necessary visits for treatment)(18 months)
- quality of life measured by OHIP14(18 months)