NCT06615544进行中（未招募）不适用
Clinical Evaluation of a New Dual-cure Universal Adhesive for Indirect Restorative Treatment
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Postoperative Hypersensitivity
研究概览
简要总结
The overall aim of this study is to evaluate the clinical performance and safety of the new dental dual-cure adhesive for luting indirect ceramic restorations (inlays and onlays). The primary aim is to determine the rate of postoperative hypersensitivity occurrence after using the new adhesive for the placement of indirect restorations. The secondary objective of this study is to assess the long-term clinical performance of the new adhesive in terms of marginal quality, retention/fracture rate of the ceramic restorations, and vitality/fracture rate of the restored teeth.
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
- •Age: 18-65 years
- •Informed consent signed and understood by the subject
- •Indication for indirect restorations (inlay, onlay) in molar or premolar
- •The occlusal area of the restoration must cover at least 1/3 of the occlusal area of the tooth.
- •visual analogue scale (VAS)<4 (0=no pain, 10=maximum conceivable pain)
- •Max. 2 restorations per participant in different quadrants.
- •Vital tooth
- •Healthy periodontium, no active periodontitis
- •Contact with adjacent teeth (at least at one side) and opposing teeth present with at least one contact point.
- •Sufficient language skills
排除标准
- •Insufficient isolation
- •Participants with a proven allergy to one of the ingredients of the materials used
- •Participants with proven allergy to local anaesthetics
- •High caries activity/ poor oral hygiene
- •Participants with severe systemic diseases
- •Pregnancy
- •Tooth with irreversible pulpitis
- •Indication for direct pulp capping
- •Bleaching of teeth within the last 14 days
- •Usage of peroxide-based disinfectants within the last 14 days
结局指标
主要结局
Postoperative Hypersensitivity
时间窗: 1 month
will be assessed according to FDI criteria (grade 1-5, lower scores mean a better outcome)
次要结局
- Marginal Quality(5 years)
- Fracture Rate(5 years)
研究者
研究点 (2)
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