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临床试验/NCT03540264
NCT03540264Unknown不适用

Tooth Wear : Diagnosis- Treatment Decision- Management- Monitoring- Randomized Clinical Trial

Cliniques universitaires Saint-Luc- Université Catholique de Louvain2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2018年2月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
52
试验地点
2
主要终点
Restoration

研究概览

简要总结

Tooth wear is a physiological process occurring from normal functioning of the dentition throughout lifetime.

详细描述

The studies in the current literature indicated that both techniques of tooth preparation and the materials used are appropriate for the treatment of this condition, but the tendency is to reduce tooth preparation as reasonably possible. In this clinical trial, the investigators will compare the outcomes of direct resin composite and indirect polymer-infiltrated-ceramic-network.

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
Single (Outcomes Assessor)

盲法说明

The statistician will be blind to the treatment assigned to indivivual patients.

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

  • Patients aged 18 years or older, in good general health, willing to participate in the study and accepting to come to regular controls in the future.
  • Patients representing any type of significant tooth wear (≥ 1 mm depth) with dentine exposure in at least 4 teeth: localized tooth wear anterior or posterior teeth and generalized tooth wear anterio and posterior teeth.
  • Patients having posterior support with at least 4 molars in occlusion, 1 pair per side, excluding third molar.

排除标准

  • Patients wearing removable partial prosthesis
  • Patients presenting skeletal Cl III occlusal Relationship
  • Patients with remaining clinical crown of ≤ 3 mm in height and presenting tooth anomaly in shape and number in addition to anterior diastemas.
  • Patients with symptomatic temporomandibular joint disorders.

研究组 & 干预措施

Composite resin

Active Comparator

Restoration with composite resin has shown good clinical performance and limited occlusal wear. The Clearfil Majesty will be used in the present study.

干预措施: Clearfil Majesty TM (Device)

Polymer-infiltrated-ceramic-network

Active Comparator

This hybrid material seems to be a promising material that imitates natural tooth properties. The VITA-Enamic® will be used in this study.

干预措施: Vita-Enamic® (Device)

结局指标

主要结局

Restoration

时间窗: up to 3 years

by modified USPHS criteria

次要结局

未报告次要终点

研究者

发起方
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
申办方类型
Other
责任方
Sponsor

研究点 (2)

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