Marginal Integrity of Resin Composite Restoration With & Without Surface Pretreatment by Gold & Silver Nanoparticles Versus Chlorhexidine in Class II Cavities Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Marginal adaptation
研究概览
简要总结
The aim of this study to detect the effect of Nano Care Gold on marginal integrity of resin composite restoration
详细描述
This study will be divided into 3 groups (control, Nano Care Gold, Chlorhexidine). Both materials will be used as a surface pre-treatment. Their effect on marginal integrity will be evaluated through evaluation of marginal adaptation, marginal staining, post-operative sensitivity. The follow up period is one year
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
- 17 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(1) Patients with at least two class II cavities (2) 17-50 years old (3) Males or females (4) Good or hygiene (5) Good general health (6) Cooperative patients (7) Subjects who signed the informed consent
排除标准
- •Patients younger than 17 years or older than 50 years old
- •Pregnant females
- •Disabilities
- •Systemic disease or severe medical complications
- •Heavy smoking
- •Lack of compliance
研究组 & 干预措施
Chlorhexidine
2% chlorhexidine gluconate solution will be applied to prepared cavity followed by adhesive system then resin composite. This arm will be compared with no intervention (negative control).
干预措施: Chlorhexidine (Other)
Nano Care Gold
Silver and Gold nano particles suspended in 70 % isopropyl alcohol. It will be used for cavity pre-treatment. This arm will be compared with no intervention (negative control).
干预措施: Nano Care Gold (Other)
Chlorhexidine
2% chlorhexidine gluconate solution will be applied to prepared cavity followed by adhesive system then resin composite. This arm will be compared with no intervention (negative control).
干预措施: No intervention (Other)
Nano Care Gold
Silver and Gold nano particles suspended in 70 % isopropyl alcohol. It will be used for cavity pre-treatment. This arm will be compared with no intervention (negative control).
干预措施: No intervention (Other)
结局指标
主要结局
Marginal adaptation
时间窗: 1 year
It will be measured by FDI probe and Digora x-ray machine. FDI Scoring system (categorical) 5 steps(3 accepted, 2 unaccepted) will be used to evaluate the outcome of measuring device
次要结局
- Marginal staining(1 year)
- Post operative sensitivity(1 year)
研究者
Aya Abd El-Fattah Mohammed
Assistant Lecturer of Conservative Dentistry
Cairo University