Twenty-Four-Month Clinical Comparison of Two Bulk-Fill and Microhybrid Composite Restorations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 主要终点
- Clinical Acceptability
研究概览
简要总结
ABSTRACT Objective The aim of this study was to evaluate the clinical performance of one microhybrid and two bulk-fill resin composites in Class II cavities for up to two years.
Materials and methods In total, 75 Class II restorations were made in 25 patients, using three restorative materials: two nanohybrid bulk-fill resin composites, Sonic Fill (SF) and x-tra fil (XF), and a microhybrid composite, Filtek Z-250 (FZ). The restorations were blindly evaluated by two examiners at baseline and at 6, 12, and 24 months, using U.S. Public Health Service (USPHS) criteria. The restoration groups for each category were compared using the Pearson chi-square test, and the Cochran Q-test was used to compare the changes across different time points within each restorative material (p <0.05).
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
- None
入排标准
- 年龄范围
- 18 Years 至 22 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient in need of restoration of caries lesion (diagnosed with bitewing radiograph and clinical examination);
- •teeth in need of restoration to be first or second molars or permanent premolars;
- •at least three Class II restorations required in each patient and the number of restorations of each material to be equal in each patient;
- •the antagonist and adjacent tooth in contact;
- •pulp vitalized and free of painful symptoms; teeth involved not to have undergone direct pulp capping;
- •no history of hypersensitivity in the teeth to be restored;
- •permanent dentition;
- •good oral health and absence of periodontal disease;
- •patients not to have suffered from systemic diseases or allergies;
- •absence of deleterious habits, xerostomia, and bruxism.
排除标准
- •Fewer than 20 teeth;
- •history of existing tooth sensitivity;
- •known allergy to resin-based materials or any of the other materials used in this study;
- •pregnancy or breastfeeding;
- •chronic use of anti-inflammatory drugs, analgesic, and/or psychotropic drugs;
- •non-vital teeth;
- •abutment teeth for fixed or removable prostheses.
结局指标
主要结局
Clinical Acceptability
时间窗: Twenty-Four-Month
One week after restoration placement (baseline), patients were recalled and restorations were examined clinically. Direct clinical evaluation of restorations was performed using the USPHS criteria by two independent investigators using mirrors, probes, and bitewing radiographs and scored as Alpha, Bravo, or Charlie. Alpha corresponded to excellent, Bravo to clinically acceptable, and Charlie to clinically unacceptable results. Patients were recalled at 6, 12, and 24 months for assessments of the restorations, using the same criteria as at baseline. At each recall, the same two calibrated evaluators, who were blinded to the restoratives used for cavities and patients, examined the restorations. To ensure a double-blind study, the evaluators were not informed about which filling material had been used on which teeth.
次要结局
未报告次要终点
研究者
Emine Sirin Karaarslan
Assoc.Proffesor
Tokat Gaziosmanpasa University