Two-year Clinical Performance of Dual- and Light-cure Bulk-fill Resin Composites in Class ӀӀ Restorations: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Esthetic properties (FDI criteria)
研究概览
简要总结
This study (a double-blinded, prospective, randomized clinical trial) aimed to evaluate 2-year clinical performance of dual- and light-cure bulk-fill resin composites in Class ӀӀ restorations.
The null hypothesis tested in this study was that, there would be no difference in the 2-year clinical performance of all tested bulk-fill resin composites in Class II restorations.
Forty patients were enrolled in the study. Each patient received three bulk-fill resin composites Class ӀӀ restorations. One dual-cure and two light-cure bulk-fill resin composites were used for Class ӀӀ restorations following manufacturer's instructions. A universal adhesive was used with all restorations. All restorations were clinically evaluated after 1 week (baseline), 6 months, 12 months, 18 months and finally after 24 months using the FDI World Dental Federation criteria.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Except the investigator, the participants and the two clinical examiners were blinded to the type of bulk-fill resin composite applied in each tooth (a double-blinded clinical trial).
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •each participant should have at least three permanent molars and premolars that need to be treated with Class II restorations due to primary carious lesions.
- •all participants required to have a full and normal occlusion and to maintain adequate oral hygiene.
排除标准
- •General exclusion criteria:
- •heavy bruxism.
- •poor oral hygiene.
- •chronic or severe periodontitis.
- •a history of allergies to any of the materials utilized in this study.
- •pregnant or nursing females.
- •Specific exclusion criteria:
- •fractured or visibly cracked teeth.
- •rampant caries.
- •faulty restoration opposite or adjacent to the tooth to be restored.
- •atypical extrinsic staining.
结局指标
主要结局
Esthetic properties (FDI criteria)
时间窗: From baseline to 2-year follow-up
Including five parameters (surface luster, margin staining, surface staining, color match \& translucency, and esthetic anatomical form). Each parameter is exhibited by five scores (1, 2, 3, 4, 5), score 1 is the best outcome. Three scores for acceptable (1, 2, 3) and two scores for non-acceptable (4 for reparable and 5 for replacement).
Functional properties (FDI criteria)
时间窗: From baseline to 2-year follow-up
Including five parameters (marginal adaptation, occlusal wear, proximal contact, radiographic examination, and fracture of material \& retention). Each parameter is exhibited by five scores (1, 2, 3, 4, 5), score 1 is the best outcome. Three scores for acceptable (1, 2, 3) and two scores for non-acceptable (4 for reparable and 5 for replacement).
Biological properties (FDI criteria)
时间窗: From baseline to 2-year follow-up
Including three parameters (post-operative sensitivity, recurrence of caries, and tooth integrity). Each parameter is exhibited by five scores (1, 2, 3, 4, 5), score 1 is the best outcome. Three scores for acceptable (1, 2, 3) and two scores for non-acceptable (4 for reparable and 5 for replacement).
次要结局
未报告次要终点
研究者
Mohamed Elshirbeny Mohamed Elawsya
Lecturer, Department of Conservative Dentistry, Faculty of Dentistry, Mansoura University, Mansoura, Egypt
Mansoura University