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临床试验/NCT04326816
NCT04326816已完成不适用

Restorative Treatment of Severe Tooth Wear; Direct vs Indirect

Radboud University Medical Center0 个研究点目标入组 42 人开始时间: 2010年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
42
主要终点
Failure level 2

研究概览

简要总结

This study compares the survival rates of both direct and indirect resin-based composite restorations in the treatment of severe tooth wear.

详细描述

Tooth wear can lead to pain, discomfort and unsatisfying dental attractiveness and when severe, it can compromise the dentition's prognosis. Restorative therapies for treatment of severe tooth wear should be preferably minimally invasive and adhesive.

This study compares two different treatment techniques for severe tooth wear. The first technique is regarded as the 'standard' technique. This is a full rehabilitation using only direct composite restorations (AP-X, Kuraray, Japan).

The second technique comprises a full rehabilitation using both direct and indirect resin composite restorations (Estenia C&B, Kuraray, Japan). 10 indirect restorations are placed on specific elements i.e. first molars and palatal sides of all maxillary anterior teeth. Other elements are restored conform the direct protocol.

An important benefit for the patients is the rehabilitation of their worn dentitions. Functionality (teeth are less sensitive, improved chewing ability, better occlusal stability, etc) and aesthetics will be improved immediately after finishing the treatment.

Indirect techniques have the advantage of a superior control over form of restorations.

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

  • Patients age of at least 18 years old.
  • Generalized moderate to severe tooth wear (Tooth Wear Index (TWI) ≥ 2) with a patient demand for treatment (Smith 1984)
  • Full dental arches, but one diastema due to one missing tooth in the posterior area was allowed.
  • An estimated need for increase of vertical dimension of occlusion (VDO) of ≥3mm at the location of the first molars.

排除标准

  • Limited mouth opening (<3.5cm).
  • (History of) Temporomandibular dysfunction, periodontitis, deep caries lesions or multiple endodontic problems.
  • Local or systemic conditions that would contra-indicate dental procedures.
  • Patients with specific individual risk factors, such as parafunctional habits of grinding/clenching or patients with GORD (Gastro Oesophageal Reflex Disease), were not excluded.

结局指标

主要结局

Failure level 2

时间窗: Failures 3 years after placement

Number of repaired direct and indirect restorations in the treatment. The higher the number the worse the outcome.

Failure level 3

时间窗: Failures 3 years after placement

Number of refurbished direct and indirect restorations in the treatment due to material chippings. The higher the number the worse the outcome.

Failure level 1

时间窗: Failures 3 years after placement

Number of replaced direct and indirect restorations in the treatment. The higher the number the worse the outcome.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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