NCT01369134已完成不适用
Clinical Evaluation of 3M ESPE Adper Easy Bond Self-Etch Adhesive Using a Selective Etch Technique
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Retention of the Restoration
研究概览
简要总结
Study hypothesis: Etching the enamel followed by use of a self-etching adhesive on enamel and dentin is as effective as a one-step etch and rinse approach.
详细描述
There is scant evidence available on the performance of self-etching dental adhesive systems. This study aims to clinically evaluate a self-etch adhesive used either with an extra enamel etching step, or in a self-etch stand alone technique with no extra enamel etch.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •written informed consent
- •regular dental attender, can return to clinic for study recalls
- •good medical health
- •normal saliva flow
- •has one or two pairs of back teeth that require a Class I or II restoration of appropriate size
- •study teeth that are vital
排除标准
- •currently in an evaluation of other dental materials
- •an irregular dental attender
- •has unacceptable oral hygiene standards
- •has chronic periodontitis or rampant caries
- •has teeth with signs of periapical pathology
- •has history of pulp problems, and/or needs pulp treatment
- •women who are pregnant or breast-feeding
- •has known allergy to resin composite or latex
- •has serious chronic disease requiring hospitalization
- •has oral soft tissue pathologies
- •takes medications which, in the opinion of the investigator, could interfere with the conduct of the study
- •has current or recent history of alcohol or other substance abuse
- •is an employee of the sponsor or the study site, or members of their immediate family
- •has had any restorative treatment of teeth involved in the study in the last twelve months
结局指标
主要结局
Retention of the Restoration
时间窗: one year
Bonded filling still in place
次要结局
- Clinical performance of the study restoration(one year)
研究者
研究点 (1)
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