Clinical Performance of an Innovative Self-cure Bulk-Fill Composite Compared to Dual-Cure and Light-Cure Bulk-Fill Composite in Posterior Restorations (A Randomized Controlled Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The functional properties of the examined restorations
研究概览
简要总结
This clinical trial aimed to compare the 1-year clinical performance of a self-cure bulk fill (Stela Capsules), a dual-cure bulk fill (Fill-Up), and a light-cure bulk fill (Tetric N-ceram bulk fill) in class II dental composite restorations
详细描述
A total of 60 direct class II restorations were divided into three groups: Group I (n=20): were restored with self-cure bulk-fill (Stela capsules) with Stela primer; Group II (n=20): were restored with dual-cure bulk-fill (Fill-up) with ParaBond adhesive system; Group III (n=20): were restored with light-cure bulk-fill (Tetric N-ceram bulk fill) with Tetric N-ceram universal adhesive. Each material was applied using its manufacturer-recommended self-etch adhesive protocol. All restorations were clinically evaluated after 1 week (baseline) and 3, 6, 9, and 12 months using the Revised FDI World Dental Federation (FDI) criteria. Comparisons of FDI criteria between the three groups and across different timepoints within each group were performed using Friedman and post-hoc Bonferroni tests. The significance level was set at p-value < 0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The presence of proximal caries on posterior teeth in a digital x-ray with a score of 2 to 4 according to the radiographic International Caries Detection and Assessment System (ICDAS).
- •The antagonist and the adjacent tooth make contact.
- •The teeth should have no signs of pulpitis.
- •Patients with no periodontal disease
- •No major systemic disorders or allergies
排除标准
- •- Extensive cavitated lesions, medical compromise, and traumatic malocclusion, bruxism, or parafunctional habits.
研究组 & 干预措施
Group II: dual-cure bulk-fill (Fill-up) with ParaBond adhesive system
干预措施: Group II (n=20): were restored with dual-cure bulk-fill. (Other)
Group III: light-cure bulk-fill (Tetric N-ceram bulk fill) with Tetric N-ceram universal adhesive.
干预措施: Group III (n=20): were restored with light-cure bulk-fill. (Other)
Group I: self-cure bulk-fill (Stela capsules) with Stela primer
干预措施: Group I (n=20): were restored with self-cure bulk-fill. (Other)
结局指标
主要结局
The functional properties of the examined restorations
时间窗: 1 year
All restorations were assessed clinically at 1 week (baseline) and subsequently at 3, 6, 9, and 12 months, following the FDI evaluation criteria and scoring system, which indicates: Functional properties: (F1) Fracture of material and retention. (F2) Marginal adaptation. (F3) Proximal contact point. (F4) Form and contour. (F5) Occlusion and wear. Each evaluated property was scored according to the FDI criteria using the following clinical scores: Score 1: Clinically excellent/very good (VG), Score 2: Clinically good (CG), score 3: Clinically satisfactory (CS), score 4: Clinically unsatisfactory (CU), score 5: Clinically poor (PO).
The biological properties of the examined restorations
时间窗: 1 year
All restorations were assessed clinically at 1 week (baseline) and subsequently at 3, 6, 9, and 12 months, following the revised FDI evaluation criteria and scoring system, which indicates: Biological properties (B1) Caries at restoration margins. (B2) Dental hard tissue defects at the restoration margin. (B3) Postoperative hypersensitivity and pulpal status. Each evaluated property was scored according to the FDI criteria using the following clinical scores: Score 1: Clinically excellent/very good (VG), Score 2: Clinically good (CG), Score 3: Clinically satisfactory (CS), Score 4: Clinically unsatisfactory (CU), Score 5: Clinically poor (PO).
The aesthetic properties of the examined restorations
时间窗: 1 year
All restorations were assessed clinically at 1 week (baseline) and subsequently at 3, 6, 9, and 12 months, following the FDI evaluation criteria and scoring system, which indicates: Aesthetic properties: (A1) Surface luster and surface texture. (A2) Marginal staining. (A3) Color match. Each evaluated property was scored according to the FDI criteria using the following clinical scores: Score 1: Clinically excellent/very good (VG), Score 2: Clinically good (CG), Score 3: Clinically satisfactory (CS), Score 4: Clinically unsatisfactory (CU), Score 5: Clinically poor (PO).
次要结局
未报告次要终点
研究者
Marwan Abdelnaser
Instructor of operative Dentistry
Alexandria University