Randomized Controlled Trial on Glass Hybrid Versus Composite Restorations of Non-carious Cervical Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Number of restorations with a re-intervention per all restorations
研究概览
简要总结
A glass hybrid restorative system (EQUIA forte) clinically compared to a composite resin based material (Clearfil SE Bond, Filtek Supreme XT) for the treatment of dental non-carious cervical lesions.
详细描述
This is a prospective, randomized, monocenter parallel group study on restoration of tooth with non-carious cervical restorations. Each patient receives cervical restoration(s) either with glass hybrid EQUIA forte or with composite resin/adhesive combination Filtek Supreme XT/Clearfil SE Bond in anterior/posterior tooth region. Restorations will be provided by one experienced operator. One of two independent examiners will evaluate the restorations at baseline (1 week after placement), and after 18, and 36 months according to the FDI criteria. Reliability of examination will be assessed on a random sample of 30 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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •indication of a restorative treatment for a sclerotic non-carious cervical lesion
- •lesions should be accessible for treatment and visual-tactile re-evaluation
- •sufficient moisture control should be possible
- •cervical margins should be located in dentin whereas the coronal margin should be located in enamel
排除标准
- •allergy/hypersensitivity against any of the used materials
- •participants should not be systematically ill, disabled, pregnant or participating in another study
结局指标
主要结局
Number of restorations with a re-intervention per all restorations
时间窗: 36 months
Number of all restorations with a re-intervention being required per all placed restorations (events/sample)
次要结局
- Costs for initial and retreatment(recorded initially and, if required, each re-treatment appointment, over the total trial period (i.e. expected 36 months))
- Restoration score(36 months)
研究者
Falk Schwendicke
PD Dr.
Charite University, Berlin, Germany