Prospective, Randomized, Controlled, Double Blind Trial of Two Universal Composites in Posterior Teeth
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
- Observers evaluated the esthetic properties of the restorations using FDI (World Dental Federation) Criteria.
研究概览
简要总结
The aim of this randomized, prospective clinical study was to compare the clinical performance of a universal light-curing, ultra-fine particle hybrid composite with a new version of this product produced by the same manufacturer in Class 1 and Class 2 lesions.
详细描述
A total of 80 (13 Class 1 and 67 Class 2) lesions in 40 patients (21 females, 19 males) with ages ranging between 18-38 years (23.15±5.15) were either restored with Charisma or Charisma Classic (Heraeus Kulzer) in combination with an etch and rinse adhesive system (Gluma 2 Bond) under rubber dam isolation by two experienced operators according to the manufacturer's instructions. Two independent examiners, who were blinded to the composites used evaluated the restorations according to the FDI (World Dental Federation) criteria. Bite-wing radiographs and intraoral digital photographs were taken before and after treatment and at 6 months. The statistical analyses were carried out with McNemar, Pearson Chi-square and Cochran Q tests (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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •a need for at least two but not more than four posterior tooth-colored restorations
- •the presence of teeth to be restored in occlusion
- •teeth that were symptomless and vital
- •a normal periodontal status
- •a good likelihood of recall availability.
排除标准
- •partly erupted teeth
- •absence of adjacent and antagonist teeth
- •poor periodontal status
- •adverse medical history
- •potential behavioral problems.
结局指标
主要结局
Observers evaluated the esthetic properties of the restorations using FDI (World Dental Federation) Criteria.
时间窗: The changes at restorations were obtained from baseline (one week after treatment), 6 month, 1, 2, 3 and 4 year.
"Surface luster"; "Staining (surface, margins)"; "Color match and translucency"; "Esthetic anatomical form"
次要结局
- Observers evaluated the functional properties of the restorations using FDI (World Dental Federation) Criteria.(The changes at restorations were obtained from baseline (one week after treatment), 6 month, 1, 2, 3 and 4 year.)
研究者
Zeynep Bilge Kutuk
Research Assistant
Hacettepe University