NCT04933123终止不适用
Clinical Evaluation of a New Dental Glass Ceramic in the Indirect Restorative Therapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Survival Rate of Inlays and Onlays
研究概览
简要总结
A clinical trial with an experimental glass ceramic (shades A1, A2 and A3) to ensure the safety and efficacy of the product. It is a study with single-arm in which inlays and onlays for molars and premolars are adhesively luted.
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
- •Indication for indirect restorations (inlay, onlay) in molar or premolar - replacement of insufficient fillings (e.g. due to caries at margins, filling fracture, fracture of the tooth, poor quality of the surface, leaking margin, etc.) or extensive primary caries
- •The occlusal area of the restoration must cover at least 1/3 of the occlusal area of the tooth.
- •Participant wishes a restoration within the scope of the study (signed informed consent after detailed explanation and study of the patient information)
- •Pre-operative discomfort of the tooth to be restored should not exceed 3 on the visual analogue scale (VAS) (0=no pain, 10=maximum conceivable pain) due to temperature stimulus or bite sensitivity
- •Max. 2 restorations per participant in different quadrants.
- •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
- •Sufficient isolation not possible, dry working field cannot be guaranteed
- •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
- •Symptoms of SARS (severe acute respiratory syndrome)-CoV2 (Corona Virus 2) infection
结局指标
主要结局
Survival Rate of Inlays and Onlays
时间窗: Baseline (7-10 days after insertion of restoration)
Inlay and onlay restorations were examined by a dentist
次要结局
- Quality Criteria (Modified FDI Criteria)(Baseline (7-10 days after insertion of restoration))
研究者
研究点 (2)
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