Randomized Clinical Trial of the Effect of Different Categories of Adhesive System
试验速览
- 阶段
- 2 期
- 入组人数
- 185
- 试验地点
- 2
- 主要终点
- Retention rate
研究概览
简要总结
This study aims to evaluate the clinical effectiveness of contemporary resin-based adhesive systems by retention rate of resin restorations placed in non carious cervical lesions with four different adhesive strategies: 3 and 2 steps etch-and-rinse adhesive system, 2 and 1 step self-etch adhesive systems.
详细描述
The etch-and-rinse (3 and 2 steps) and self-etch (1 and 2 steps) adhesive systems allow the bond between the resins restorations with the dental substrates, but they have mechanism of action different.
The success of resin composite restorations is reliant upon adhesion to the underlying tooth via adhesive systems. The mechanism of adhesion to enamel and dentine could be involved for one hand, the etching the substrates with 30-40% phosphoric acid, followed by the application of a primer and subsequently an adhesive resin 3 steps etch-and- rinse approach or 2 steps when to combine the primer and adhesive into one bottle. For another hand, the self- etch systems with acid monomers in their primer, allow conditioning the surface without phosphoric acid step. So, they consist of either a self-etching primer accompanied by an adhesive resin applied as a subsequent step (2 steps) or a self-etch adhesive, which does not require a separate primer (1 step).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Good general health,
- •Patients with acceptable oral hygiene level,
- •Patients with at least 20 teeth under occlusion.
- •Patients with at least four non-carious cervical lesions in four different teeth
- •Patients with maximum of eight lesions that needed to be restored.
- •These lesions had to be non-carious, non-retentive, deeper than 1 mm, and involve both the enamel and dentin of vital teeth without mobility.
排除标准
- •Patients with extremely poor oral hygiene,
- •Patients with severe or chronic periodontitis,
- •Patients with heavy bruxism habits.
结局指标
主要结局
Retention rate
时间窗: one year
retention rate of the dental restorations
Secondary caries
时间窗: one year
Secondary caries near and/or associated of the dental restorations
次要结局
- Marginal integrity(one year)
- Marginal discoloration(one year)
- post-operative sensitivity(one year)
研究者
Issis luque
Professor
Universidad de Valparaiso