Clinical Investigation of a New Nanohybrid Resin Composite Venus Pearl in Class 2 Cavities- a Multi-center Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 4
- 主要终点
- Score for Surface Luster
研究概览
简要总结
The purpose of this study is to compare the clinical performance of a new resin based filling material to an established resin-based filling material in posterior teeth at 2 different study centers.
详细描述
The objective of this study is to compare the performance of the composite resin Venus Pearl and a commercially available control composite material for the restoration of class II-cavities. Primary endpoints of the study are a mean score for each patient calculated from aesthetic, functional attribute and biological parameters. Secondary endpoints are the evaluation of secondary caries, plaque accumulation and gingival reactions and the comparison of the primary score at week 1, month 6, month 12 and month 24 after restoration. Beside this, the single components of the three categories of the primary endpoints will be compared. The study will be executed as a multi-center (Oregon Health & Science University, Portland, OR, USA and Medical School Hannover, Hannover, Germany), single-blinded and randomized clinical investigation. 90 comparable cavities per study site will be treated (45 cavities for each material at each site).
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients should be 18 years and older.
- •Study teeth should have an interproximal (Class II) carious lesion or an existing defective class II restoration requiring restorative therapy on premolars or molars.
- •The maximum cavity depth determined by the radiograph will be D2 (Tyas classification).
- •The teeth included in the study need to have a proximal contact with the adjacent tooth and be in occlusion with the opposing dentition.
- •The teeth included in the study should be vital with no signs of pulpal pathology.
- •Patients that report brushing regularly without severe gingival inflammation and/or extensive caries.
- •Patients should have no allergies or systemic diseases which inhibit the treatment.
- •Patients should have voluntary participation and sign a written informed consent form.
- •Patients should be willing to participate in the recall/re-examination appointments.
排除标准
- •Simultaneous participation in another study about dental restorative materials.
- •Written informed consent form not signed.
- •Nonvital pulp / periapical lesion.
- •Insufficient oral hygiene despite detailed instructions.
- •Pregnancy/ breast feeding before placement of the study restoration.
- •Severe malocclusion/ malalignment/ traumatic occlusion/ bruxism.
- •Known allergy to any components present in any of the materials that are used for this study.
- •Unclear mucosal alterations, e.g. oral lichenoid reactions/lesions.
- •Severe medical complications (organ transplants, cancer, immune-compromised, long-term antibiotic or steroid therapy).
- •Infectious diseases such as HIV/Aids, Hepatitis, etc.
- •Application of bleaching products less than 14 days before placement of the restoration.
- •Orthodontic treatment during the study.
- •Xerostomia.
- •Untreated periodontal diseases.
- •Rampant or extensive caries present.
- •Systemic diseases with potential oral manifestation.
- •Sufficient isolation according to the criteria of adhesive techniques not possible, e.g. application of rubber dam.
- •Direct adhesive restoration not indicated.
- •Replacement of more than one cusp indicated.
- •Dental fears patients.
结局指标
主要结局
Score for Surface Luster
时间窗: 2 years
The primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters. Score of esthetic properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for surface luster
Score for Surface Staining
时间窗: 2 years
The primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters. Score of esthetic properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for surface staining
Score for Marginal Discoloration
时间窗: 2 years
The primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters. Score of esthetic properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for marginal discoloration
Score for Fracture and Retention
时间窗: 2 years
The primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters. Score of functional properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for fracture and retention
Score for Color Match
时间窗: 2 years
The primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters. Score of esthetic properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for color match
Score for Esthetic Anatomical Form
时间窗: 2 years
The primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters. Score of esthetic properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for esthetic anatomical form
Score for Marginal Adaptation
时间窗: 2 years
The primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters. Score of functional properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for marginal adaptation
Score for Abrasion
时间窗: 2 years
The primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters. Score of functional properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for abrasion
Score for Approximal Anatomical Form
时间窗: 2 years
The primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters. Score of functional properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for approximal anatomical form
Score for Satisfaction of Patient
时间窗: 2 years
The primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters. Score of functional properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for satisfaction of patient
Score for Post-operative Hypersensitivity
时间窗: 2 years
The primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters. Score of biological properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for post-operative hypersensitivity
Score for Caries, Erosion
时间窗: 2 years
The primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters. Score of biological properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for caries, erosion
Score for "Tooth Integrity"
时间窗: 2 years
The primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters. Score of biological properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for "tooth integrity"
Score for Parodontal Reaction
时间窗: 2 years
The primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters. Score of biological properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for parodontal reaction
Score for Adjacent Mucosa
时间窗: 2 years
The primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters. Score of biological properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for adjacent mucosa
次要结局
未报告次要终点