5-year Clinical Evaluation of Cavity Lining on the Restoration of Root Surface Caries Lesions: A Controlled Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 38
- 主要终点
- Retention Outcome
研究概览
简要总结
The purpose of this double-blind, randomized trial is to compare the clinical performance of a composite restorations in root surface carious lesions with or without resin modified glass ionomer lining.
详细描述
Thirty-nine patients with at least one pair of equivalent root caries lesions and a mean age of 39.6 years (range 18-65 years; median 39 years) were enrolled in this study. After caries removal, the depth, length, and width of the cavity were measured. Lesions in the same patient was randomly divided into two groups, and the dentin surfaces were either lined with resin-modified glass ionomer liner (Glass liner II, Willmann & Pein GmbH Dental, Barmstedt, Germany) or not. All cavities were restored with nanohybrid composite resin (Clearfil Majesty Esthetic, Kuraray, Tokyo, Japan). A total of 100 restorations (50 lined, 50 unlined) were placed according to manufacturer's instructions. The restorations will be evaluated at baseline and at 6, 12, 24, 36, 48 months and 5-year after placement using the modified Haveman Criteria for marginal adaptation, anatomic form, marginal staining, anatomic form, caries in adjacent tooth structure, caries at the cavosurface margin and sensitivity. Statistical analysis will be conducted using the Chi- Square, Fisher's Exact, Mann Whitney-U and Cochran Q tests at a significance level of 5% (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 67 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 treatment for caries lesions on the root surface
排除标准
- •Patients who were under the age of 18 years
- •Complex medical history
- •Severe or chronic periodontitis
- •Extreme carious activity
- •Heavy bruxism
- •Very deep or superficial carious lesions
- •Previously restored and abutment teeth
研究组 & 干预措施
Glass Liner
Tooth restoration with a glass ionomer liner material under a nanohybrid composite resin
干预措施: Glass Liner (Device)
No liner
Tooth restoration without a glass ionomer liner material under a nanohybrid composite resin
结局指标
主要结局
Retention Outcome
时间窗: 5 years
1.Retention Alpha for at least 90% of the restorations 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 (American Dental Association) guidelines, a restorative material should show at leat 90% alpha retention rate after 18 months to be considered as clinically acceptable. The retention is assessed as alpha (retentive restoration) or charlie (failed restoration). Clinical evaluation is performed to examine if the restoration is in place or has fallen.
次要结局
未报告次要终点
研究者
Uzay Koc
Principal Investigator
Hacettepe University
