Clinical Investigation of the F-Composite 2 System in Direct Filling Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Percentage of Restored Teeth With Postoperative Sensitivity
研究概览
简要总结
The objective of this study is to evaluate the clinical performance of F-Composite 2 system in Class I and Class II cavities in permanent teeth.
The materials of the system can be polymerized in short time with a curing light which is part of the system.
The study will be carried out as a prospective study, with evaluation of the restorations after 7-10 days (baseline), at 6 months, at 12 months, at 24 months and 60 months according to defined criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication for direct filling of Class I or II with permanent premolars or permanent molars
- •replacement of insufficient fillings (e.g., due to edge caries, filling fracture, Lack of quality of the surface, lack of aesthetics, undesirable filling material, leaky edge, edge gap, etc.)
- •extensive primary caries
- •Vital tooth (cold test)
- •One-, two- or three-surface fillings in the lateral tooth area, with a maximum of 25% single-faced (Class I) with antagonists.
- •The occlusal area of the filling must be at least 1/3 of the total area of the filling tooth. This criterion is estimated.
- •Patient wishes to receive care within the framework of the study (written consent after detailed elucidation and study of patient information).
- •Maximum of 2 restorations per patient.
- •Preoperative complaints on the tooth to be restored (maximum 3 on visual Analog scale (0 = complaint-free, 10 = maximum possible pain) to temperature or bite sensitivity
- •Sufficient language skills
排除标准
- •Unfinished hygiene phase or poor oral hygiene
- •Sufficient draining of the operating field is not possible
- •Patients with proven allergy to one of the ingredients of the materials used
- •Patient has allergies to local anesthetic agents Ultracain DS (active substance: articaine; Vasoconstrictor), if anesthesia is desired
- •Patients with severe systemic diseases
- •Devital or pulpitic teeth
- •Periodontal insufficiency
- •Supplements with cusp attachments
- •open side bite
- •missing antagonist
- •Indication for direct capping
- •Pregnancy (women of childbearing age receive a free pregnancy test for self application, the negative result of which is shown with her confirmed consent).
结局指标
主要结局
Percentage of Restored Teeth With Postoperative Sensitivity
时间窗: 1 month
The postoperative sensitivity is assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale, from 0 "no pain" to 10 "maximum pain") following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable". A maximum of 10% postoperative hypersensitivities are defined as acceptable after one month.
次要结局
- Replacement of Filling(2 years)
- Number of Restored Teeth With Loss of Vitality(12 months)