NCT00658138已完成不适用
Clinical Evaluation of 3M™ ESPE™ Adper™ Scotchbond™ SE Self-Etch Adhesive in Class I and Class II Restorations in Adults
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Percentage of Restorations Scoring Alpha
研究概览
简要总结
The purpose of this study is to evaluate the performance of a new dental adhesive system in the restoration of Class I and Class II cavities in adult teeth.
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 (Participant)
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
- •Must be at least 18 years of age
- •Must have 2 or 4 qualifying Class I or Class II cavities
- •Must be willing to sign consent form
- •Must be willing to return to University dental clinic for 4 study appointments
- •Must be in good medical health and able to tolerate dental procedures
排除标准
- •Current participation in other restorative product studies
- •Known allergies to dental products
- •Unacceptable level of oral hygiene
- •Chronic periodontitis (gum disease)
- •Rampant caries (cavities)
- •Severe salivary gland problems
- •Inability or unwillingness to attend study appointments
研究组 & 干预措施
Adhesive A
Experimental
干预措施: 3M ESPE Adper Scotchbond SE (Device)
Adhesive B
Active Comparator
干预措施: 3M ESPE Adper Scotchbond 1XT (Device)
结局指标
主要结局
Percentage of Restorations Scoring Alpha
时间窗: 12 months
Restorations were scored Alpha, Bravo or Charlie for retention, post-operative sensitivity, anatomic form, margin integrity, color match, stain resistance, and secondary caries. Alpha score = 'excellent' Bravo = 'acceptable' Charlie = 'unsatisfactory'. Total Alpha scores were evaluated for the primary outcome.
次要结局
未报告次要终点
研究者
研究点 (1)
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