24-Month Performance of a Glass-hybrid-restorative in Non-carious Cervical Lesions of Patients With Bruxism: A Split-mouth, Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 25
- 主要终点
- Retention Alpha for at least 90% of the restorations
研究概览
简要总结
This is a double blinded, split mouth, randomized clinical study that evaluated the performance of a glass hybrid restorative material in non-carious servical lesions in patients with bruxism. The lesions were restored with glass hybrid restorative (Equia Forte) or nano ceramic composite resin (Ceram-x One). Restorations were evaluated after 24 months according to USPHS criteria and the data were evaluated.
详细描述
The aim of this study was to evaluate the clinical performance of a glass-hybrid-restorative compared with a nano ceramic composite resin in non-carious cervical lesions (NCCLs) of patients with bruxism.
For this purpose, twenty-five patients having NCCLs and bruxism enrolled to the present study. Before treatment, the dimensions of the NCCLs were measured in depth, gingival-incisal height and mesio-distal width using a CPI probe. Degree of tooth wear (TWI) and gingival conditions (GI) are also recorded. A total of 148 NCCLs were randomly restored with a a glass-hybrid-restorative system (Equia Forte Fil, GC, Tokyo, Japan) or a nano ceramic composite resin (Ceram.X One Universal, Dentsply, DeTrey, Konstanz, Germany) and restorations were evaluated at baseline and after 6,12 and 24 months according to the modified-USPHS criteria. Data were analyzed with Chi- Square, Fisher's Exact Test, Mann Whitney-U and Cochran's Q tests (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
- 42 Years 至 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •non-hospitalized, healthy patients that were seeking dental treatmen
- •occlusally contacted teeth
排除标准
- •Patients having intensive medical history
- •Chronic periodontitis,
- •high caries activity,
- •extremely poor oral hygiene,
- •teeth with restorations,
- •mobility due to periodontal disease
- •in contacted with removable prosthetic construction were excluded from the study
研究组 & 干预措施
"composite resin", "Ceram-x One Universal"
tooth restoration with nano-ceramic composite resin "Ceram-x one Universal"
干预措施: tooth restoration (Device)
"glass ionomer cement", "Equia Forte"
Tooth restoration with glass ionomer cement (Glass hybrid restorative system) "Equia Forte"
干预措施: tooth restoration (Device)
结局指标
主要结局
Retention Alpha for at least 90% of the restorations
时间窗: 24 months
The primary factor for determining the clinical performance of a restorative material is the retention rate. It represents the survival rates of the restorations after a period of time. According to ADA guidelines, a restorative material should show at leat 90% alpha retention rate after 18 months to be considered as clinically acceptable. The retention is assesed as alpha (retentive restoratation) or charlie (failed restoration). Clinical evaluation is performed to examine if the restoration is in place or has fallen.
次要结局
- marginal adaptation score alpha(24 months)
研究者
Ece Meral
principal investigator
Hacettepe University