新型双固化通用粘合剂的临床评价
用于间接修复治疗的新型双固化通用粘合剂的临床评价
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.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Schaan、列支敦士登、9494
- Ivoclar Vivadent AG
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：New dual-cure adhesive
The newly developed dual-cure adhesive will be used for the placement of indirect restorations. |
The newly developed dual-cure adhesive will be used for the placement of indirect restorations. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Postoperative Hypersensitivity
大体时间：1 month
|
will be assessed according to FDI criteria (grade 1-5, lower scores mean a better outcome) |
1 month
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Fracture Rate
大体时间：5 years
|
will be assessed according to FDI criteria (grade 1-5, lower scores mean a better outcome) |
5 years
|
|
Marginal Quality
大体时间：5 years
|
will be assessed according to FDI criteria (grade 1-5, lower scores mean a better outcome) |
5 years
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.