Clinical Performance of a Micro-hybride Resin Based Composite in the Treatment of Cervical Caries Lesions: 36-month, Split-mouth, Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 33
- 主要终点
- Marginal adaptation 0 for at least 90% restorations (marginal adaption score)
研究概览
简要总结
This is a split-mouth, randomized clinical study that evaluating the 36-month performance of different restorative materials in the treatment of root caries lesions. A total of 110 restorations were randomly placed, half using resin composite (Spectrum TPH3) and the other half using the resin-modified glass ionomer cement (Riva Light Cure). Restorations were evaluated at the baseline, 6, 12, 18,24 and 36 months according to the USPHS criteria.
详细描述
The aim of the study was to comparatively assess the 36-month clinical performance of a micro hybrid resin composite and resin-modified glass ionomer cement in root caries lesions.
Thirty-three patients with at least two root caries lesions participated in this study. A total of 110 restorations were randomly placed, half using resin composite (Spectrum TPH3) and the other half using the resin-modified glass ionomer cement (Riva Light Cure). Restorations were evaluated at the baseline, 6, 12, 18, 24 and 36 months. The data were analyzed with Pearson's Chi-square, Cochran's Q, Friedman tests and Logistic Regression Analysis (p=0.05).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Root caries lesions (at least 1mm depth)
排除标准
- •Complex medical history
- •Poor dental hygiene/infrequent practise of oral hygiene habits
- •Severe or chronic periodontitis
- •Extreme carious activity
- •Heavy bruxism
- •Very deep (closer than 0.5 mm to the pulp) or superficial lesions (shallower than 1mm)
- •Previously restored and abutment teeth for bridge or removable dental prostheses
研究组 & 干预措施
Riva LC, restorative material
Restoration with resin-modified glass ionomer cement
干预措施: Spectrum TPH3 (Device)
Riva LC, restorative material
Restoration with resin-modified glass ionomer cement
干预措施: Riva LC (Device)
Spectrum TPH3, tooth restoration
Restoration with micro hybrid resin composite
干预措施: Spectrum TPH3 (Device)
Spectrum TPH3, tooth restoration
Restoration with micro hybrid resin composite
干预措施: Riva LC (Device)
结局指标
主要结局
Marginal adaptation 0 for at least 90% restorations (marginal adaption score)
时间窗: 24 months
The primary factor for determining the clinical performance of a restorative material is the marginal adaption score. It represents the survival rates of the restorations after a period of time. According to ADA guidelines, a restorative material should show at least 90% survival rate after 18. The retention scored as 0 (restoration appears to adapt closely to the surface of the tooth with no crevice formation), 1 (an explorer caught lightly when run in both directions, and there was visible evidence of early crevice formation), 2 (an explorer got caught in both directions and penetrated a marginal crevice), 3 (the crevice had sufficient depth to expose the dentin, required replacement) or 4 (The restoration was fractured or lost). Clinical evaluation is performed to examine if the restorations are in place or fallen.
次要结局
未报告次要终点
研究者
Uzay Koc
Principal Investigator
Hacettepe University