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临床试验/NCT02957734
NCT02957734Unknown4 期

The Use of LAVA Ultimate Restorations in a Full Occlusal Rehabilitation for Patients With Severe Tooth Wear

Radboud University Medical Center2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
4 期
入组人数
22
试验地点
2
主要终点
Surival of indirect composite restorations in patients treated for severe tooth wear

研究概览

简要总结

LAVA Ultimate composite restorations will be used as restorative material to reconstruct severely worn dentitions.

详细描述

Standard dental treatment will be provided to the patients with severely worn dentitions. Treatment is based on the principles of 'minimally invasive treatment techniques'.

Main difference with the 'standard' treatment protocol and the standard procedure of placing composite restorations is the fully digital workflow. In the traditional workflow a silicon impression is made, after which the dental technician produces the (indirect) composite restorations in by hand. These restorations are then adhesively cemented on the teeth by the dentist. In the fully digital workflow, digital 3D-scans are made using the 3D LAVA scanner (3M ESPE). Based on these digital 3D-images a digital wax-up is made by the dental technician after which all composite restorations (uplays and backings) are designed digitally before being milled and finally adhesively cemented on the teeth by the dentists. An important benefit for the patients is the rehabilitation of their worn dentitions. Functionality (teeth are less sensitive, improved chewing ability, a better occlusal stability, etc) and aesthetics will be improved immediately after finishing the treatment. Moreover, the estimated treatment time will be less (estimated treatment time approx. 12hours) than the traditional methods when using the standard treatment protocol (estimated treatment time approx. 18hours).

Another potential benefit is a better control and more predictable results by using 3D-images with the pre-designed computer simulation.

A risk of these indirect composite resin restorations is the unknown survival rate compared to other indirect as well as to direct application technique

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • Generalized severe tooth wear
  • Presence of functional problems
  • Necessary increase of vertical dimension of occlusion (VDO) of ≥3 mm at location of first molars
  • No edentulous space in need for treatment in the anterior region in upper and lower jaw
  • A minimum of three posterior teeth (premolars and molars) per quadrant

排除标准

  • Functional problems (mouth opening < 5cm, severe Tempero Mandibular Dysfunction)
  • Severe periodontitis (DPSI = 4)

结局指标

主要结局

Surival of indirect composite restorations in patients treated for severe tooth wear

时间窗: Failures one year after placement

Percentage of failed restorations and the clinical success of the restorations and the relation of the failures with etiological factors

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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