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临床试验/NCT02494427
NCT02494427Unknown不适用

Medico-economic Comparative Assessment of Conventional and CAD/CAM Dental Restorations; Impact on Hospital Dentistry Departments

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2014年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
200
试验地点
2
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:

  1. A costing study seeking to determine the costs of compensation for dental substance loss by conventional technique and CAD/CAM per patient ;
  2. Evaluate the cost from an hospital perspective to substitute CAD/CAM to conventional dental treatment equipments;
  3. 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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

1

Experimental

CAD/CAM manufactured fixed unitary dental prostheses

干预措施: CAD/CAM manufactured fixed unitary dental prostheses (Device)

2

Active Comparator

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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