18-Month Clinical Evaluation of Self-Adhesive Flowable Giomer Compared to Conventional Flowable Giomer in Carious Cervical Lesions: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 34
- 主要终点
- Clinical Performance
研究概览
简要总结
The material under investigation will offer the patient a high strength and high durability restoration with the advantage of having anti-bacterial properties.
详细描述
There is no available evidence for assessing FIT SA restorative material in restoration of cervical lesions. Therefore, this study aims to provide valuable insights into the shear bond strength and clinical performance, in terms of the biological, mechanical and esthetic parameters, of FIT SA restorative material in restoration of cervical lesions.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- 否
入选标准
- •Cervical carious lesions in anterior teeth and premolars
- •Small to moderate class V carious lesion (ICDAS 3 & 4).
- •Vital upper or lower periodontally sound teeth with no signs of irreversible pulpitis.
- •Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth
排除标准
- •Cervical carious lesions in molars.
- •Deep carious defects (close to pulp, less than 1 mm distance).
- •Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.
- •Non-vital teeth, Fractured or cracked teeth.
- •Endodontically treated teeth.
- •Periodontally affected teeth
研究组 & 干预措施
Beautifil Flow Plus F00
Conventional flowable giomer restorative material
干预措施: Beautifil Flow Plus F00 (Other)
FIT SA
Self adhesive flowable giomer restorative material
干预措施: FIT SA (Other)
结局指标
主要结局
Clinical Performance
时间窗: 18 months
Clinical Performance using Modified USPHS criteria
次要结局
未报告次要终点