Clinical Evaluation of a New Flowable Composite for Direct Restorative Treatment of Non-carious Cervical Lesions: A Prospective Randomized Split-mouth Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Postoperative Hypersensitivity
研究概览
简要总结
The overall objective of this clinical investigation is to evaluate the clinical safety and performance of the new flowable composite TM Flow for treatment of non-carious cervical lesions. Each participant receives two different fillings (test- and control material) in two different teeth. The fillings are assessed according to selected FDI criteria at baseline (7-10 days after filling placement) and after 1, 6, 12, 24, 36 and 60 months.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed Consent signed by the subject
- •Age: 18-65 years
- •2 NCCL needing treatment, comparable in extend and size, preferably located in different quadrants
- •Vital teeth, regular sensitivity
- •Sufficient language skills
- •No active periodontitis
- •Preoperative VAS values < 3 regarding tooth sensitivity on biting. Tooth sensitivity on temperature or touching (tooth brushing, probing) originating in the area of the NCCL is accepted.
- •Subject wishes to have a restoration as part of the study (written declaration of consent after detailed explanation)
排除标准
- •Not completed hygiene phase or poor oral hygiene
- •Sufficient isolation of the cavity not possible
- •Patients with a proven allergy to one of the ingredients (methacrylates)
- •Patients with severe systemic diseases
- •Periodontally insufficient dentition
- •Pregnancy
- •Part of the development project team of TM Flow
- •Staff of the study management team
- •Staff of the internal clinic
研究组 & 干预措施
Test goup TM Flow
The newly developed flowable composite TM Flow will be used for the restoration of NCCLs in the test group. The treatment workflow is very similar to other flowable composites.
干预措施: Restoration of non-carious cervical lesions (Device)
Control group Tetric EvoFlow
The well-established Tetric EvoFlow will be used for the restorations of NCCLs in the control group.
干预措施: Restoration of non-carious cervical lesions (Device)
结局指标
主要结局
Postoperative Hypersensitivity
时间窗: 1 month
assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable") following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" FDI 1: no complaint FDI 2: minor complaint FDI 3: distinct pain FDI 4: persistent pain for prolonged period of time FDI 5: treatment unavoidable
Postoperative Hypersensitivity
时间窗: 1 month
assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable") following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" FDI 1: no complaint FDI 2: minor complaint FDI 3: distinct pain FDI 4: persistent pain for prolonged period of time FDI 5: treatment unavoidable
次要结局
- Evaluation of Functional (e.g. Fracture of the Material and Retention), Biological (e.g. Caries at Restoration Margins) and Aesthetic (e.g. Color Match) Properties of the Restorations(5 years)