Comparative Clinical Evaluation Between a Novel Self Adhesive and Conventional Bulk-fill Composites (a Randomized Controlled Clinical Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Clinical success of the restoration
研究概览
简要总结
This study aimed to evaluate the clinical performance of a novel, tooth-colored, self-adhesive bulk-fill restorative, and a conventional bulk-fill composite, for restoring class II cavities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients in need of restorative treatment on at least two class II Cavities in premolars or molars.
- •Presence of proximal caries in digital x-ray with code 2 to 4 according to the radiographic International Caries Detection and Assessment System (ICDAS I).
- •Presence of proximal caries in initial or moderate stage according to the International Caries Classification and Management System (ICCMS™).
- •Only posterior teeth with class II cavities that have antagonistic contact and at least one proximal contact.
- •Absence of parafunctional habits.
- •Good general health
排除标准
- •Serious medical disorders
- •Clinical signs of bruxism, traumatic malocclusion
- •Pregnant or breast feeding at the time of restoration placement
- •Intolerance or allergy toward the applied restorative materials
结局指标
主要结局
Clinical success of the restoration
时间窗: up to 12 months
Clinical success of the restoration will be ranked according to the FDI Clinical Criteria which consider aesthetic, functional, and biological characteristics. The clinical assessment of the investigation criteria will be done by means of a five-score scale. FDI criteria scores 1, 2, and 3 are considered clinically excellent, good, and satisfactory. Score 4 indicates that the restoration is clinically unsatisfactory but repairable, however score 5 indicates that the restoration is clinically poor/failure and should be replaced.
次要结局
未报告次要终点
研究者
Nourhan M.Aly
Assistant Lecturer of Dental Public Health
University of Alexandria