Assessment of a New Resin-based Composite Restorative Material
试验速览
- 阶段
- 不适用
- 入组人数
- 72
- 主要终点
- Marginal Adaptation
研究概览
简要总结
Evaluation of a new resin-based composite material.
Amalgam and composite are the most commonly used restorative materials in dentistry. Due to the toxicity of mercury and the subsequent environmental problems, the search for alternatives continues and search into new composite restorative materials intensifies. The presently available composites have improved, but shrinkage of the composite during the curing procedure is still a clinical problem. A new composite restorative material has among other advantages demonstrated lower shrinkage in laboratory studies, due to a new formulation of the material.
This project aims to study the clinical performance of this new composite compared to a commonly used composite restoration material. 72 patients (158 teeth) are allocated to the project which is carried out at the School of dentistry, University of Aarhus, Denmark.
详细描述
This project aims to study the clinical performance of a new composite restoration material (Filtek Silorane®) compared to a conventional composite restoration material (Ceram X®).
Amalgam and composite are the most commonly used restorative materials, with the number of composite restorations increasing over the past 20 years. Composite restorative materials have improved considerably over the years. They have almost reached the same resistance to wear as amalgam, and are as a consequence now also used for molar restorations.
The main reasons for replacing composite restorations are fractures and caries associated with the restorations.
To reduce the risk of caries a new composite material Filtek Silorane® with reduced polymerization shrinkage has been developed.
Extensive laboratory studies have been performed on the new material, but the clinical attributes have yet to be disclosed.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients registered for treatment with a posterior multi surface composite restoration.
排除标准
- •Poor oral hygiene or teeth needing endodontic treatment.
研究组 & 干预措施
Ceram X
Fillings made with a traditional composite material (Ceram X)
干预措施: Tooth restorations with composite (Procedure)
Filtek Silorane
Fillings made with a new composite material (Filtek silorane)
干预措施: Tooth restorations with composite (Procedure)
结局指标
主要结局
Marginal Adaptation
时间窗: 1 year
次要结局
未报告次要终点