Clinical Evaluation of a New Dual Cure Universal Adhesive (Adhese Universal DC) in the Indirect Restorative Therapy: A Randomised, Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- FDI 11 Postoperative Hypersensitivity After Inlay/Onlay Restoration, FDI Score 1-5
研究概览
简要总结
A post market clinical follow up study (PMCF) with Adhese Universal DC is planned to ensure the safety and efficacy of the product. It is a study with two arms. Inlays and onlays for molars and premolars will be luted with Adhese Universal DC or Adhese Universal.
详细描述
This study aims to assess the long-term safety of Adhese Universal DC in terms of tooth vitality and failure rate of placed restorations. Tooth vitality is an indicator for the health status of the dental pulp. A vitality test is performed to acquire information about the vitality of teeth. A healthy dental pulp offers a positive response to the vitality test. Once the dental pulp is injured an irreversible inflammatory reaction starts with a possible necrosis of the dental pulp. Pulpa necrosis is followed by a negative response to the vitality test.
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
- Single (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
- •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)
- •2-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.
- •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
- •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
- •Nonvital tooth or tooth with irreversible pulpitis
- •Indication for direct pulp capping
- •Symptoms of SARS-CoV2 infection
结局指标
主要结局
FDI 11 Postoperative Hypersensitivity After Inlay/Onlay Restoration, FDI Score 1-5
时间窗: Baseline (7-10 days)
assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"
FDI 11 Postoperative Hypersensitivity After Inlay/Onlay Restorations, FDI Score 1-5
时间窗: 12 months
assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"
次要结局
- Vitality of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5(12 months)
- FDI 13 Fracture of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5(12 months)
- FDI 5 Retention/Fracture of Restorations After Inlays/Onlays Restorations, FDI Score 1-5(12 months)
- FDI 6 Marginal Quality After Inlay/Onlay Restorations, FDI Score 1-5(12 months)