Is There a Possibility That Bulk Fill Glass Hybrid Restorative Materials Could Replace Composite Resins in Treating Permanent Teeth? : A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- postoperative sensitivity
研究概览
简要总结
The aim of this study is to compare the clinical and radiographic efficacy of Equia system bulk fill glass hybrid material with composite resins in the permanent restoration of pediatric patients' permanent teeth.
详细描述
The study included 44 pediatric patients aged 8 to 16 years who applied to the Pedodontics Department of the Necmettin Erbakan University Faculty of Dentistry. The groups were formed as symmetrical teeth in the same patient using the split-mouth design. The study included class I caries lesions of 144 permanent teeth, 72 of which were restored with the Equia system bulk fill glass hybrid material [Equia Forte HT+Equia Forte Coat (GC, Co, Tokyo, Japan)] and 72 with the Charisma Smart universal composite resin (Kulzer, Gmbh, Hanau, Germany) + Clearfil SE Bond (Kuraray, Noritake, Sakazu, Okayama). Evaluations were performed clinically and radiographically by 2 physicians in the 2nd week, 3rd month, 6th month, and 12th month and the results were recorded. Clinical evaluation was carried out using modified USPHS criteria. Obtained data were statistically analyzed using Kendall's W test and Cochran's Q test for the comparison within the group, and the Chi-Square test for the comparison between the groups.
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)
入排标准
- 年龄范围
- 8 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The patient has no systemic disease
- •The patient should have good periodontal status
- •Teeth to be restored should be symptomless and vital
- •Teeth to be restored should have proximal contacts on both mesial and distal surfaces and be in occlusion with the antagonist teeth
- •Teeth that have class II caries lesions in external and middle 1/3 of dentine thickness radiographically
排除标准
- •Xerostomia and bruxism;
- •Absence of adjacent and antagonist teeth;
- •Extremely poor oral hygiene, severe or chronic periodontitis;
- •Teeth that have any restoration, endodontic treatment, periodontal and periapical pathology.
- •The patients who are undergoing orthodontic treatment
结局指标
主要结局
postoperative sensitivity
时间窗: 2 weeks-12 months
According to the amended USPHS (United States Public Health Service) criteria, a direct clinical evaluation was conducted. The scale: Alfa Bravo Charlie
secondary caries
时间窗: 2 weeks-12 months
According to the amended USPHS (United States Public Health Service) criteria, a direct clinical evaluation was conducted. The scale: Alfa Bravo Charlie
color match
时间窗: 2 weeks-12 months
According to the amended USPHS (United States Public Health Service) criteria, a direct clinical evaluation was conducted. The scale: Alfa Bravo Charlie
marginal discoloration
时间窗: 2 weeks-12 months
According to the amended USPHS (United States Public Health Service) criteria, a direct clinical evaluation was conducted. The scale: Alfa Bravo Charlie
surface texture
时间窗: 2 weeks-12 months
According to the amended USPHS (United States Public Health Service) criteria, a direct clinical evaluation was conducted. The scale: Alfa Bravo Charlie
marginal adaptation
时间窗: 2 weeks-12 months
According to the amended USPHS (United States Public Health Service) criteria, a direct clinical evaluation was conducted. The scale: Alfa Bravo Charlie
retention
时间窗: 2 weeks-12 months
According to the amended USPHS (United States Public Health Service) criteria, a direct clinical evaluation was conducted. The scale: Alfa Bravo Charlie
次要结局
- anatomic form(2 weeks-12 months)
研究者
Hazal Özer
Assist. Prof.
Necmettin Erbakan University