Randomized Clinical Trial of Heated High-Viscosity Glass Ionomer Class II Restorations in Primary Molars: 12 Months Follow Up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 主要终点
- Clinical success assessment measurement
研究概览
简要总结
Objective: The aim of this study was to assess the influence of heated in the clinical success of proximal high viscosity glass ionomer cement (GIC) restorations in primary molars.
Material & Method: This randomized, split mouth, multicenter study was performed in four different centers including 88 patients aged between 5-7 years old. Selection criteria included clinically and/or radiographically detected proximal caries extending into the dentin tissue. A total of 250 primary molars were restored with a bulk fill GIC (Equia Forte, GC, Europe) and randomly allocated to one of the following groups: 1) non-heated (n = 125) and 2) heated (n = 125). LED light (GC- D-Light DUO, Tokyo Japan) was used at standard mode 1200 mW/cm2, at 50-60 ºC, for 60 sec for heat application. All restorations were clinically evaluated using modified USPHS criteria at the baseline, 6 months and 12 months. Chi-square test, Fisher's Exact Chi-square test, Continuity (Yates) correction, Fisher Freeman Halton test and Mc Nemar test were used to compare qualitative data with descriptive statistical methods (frequency). Kaplan Meier and Life Tables were used for survival analysis. P value < 0.05 was considered statistically significant.
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
- None
入排标准
- 年龄范围
- 5 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is mentally and systemically healthy
- •Subject has at least two approximal carious lesions at both sides of jaws
- •Subject has a normal occlusal relationship with natural dentition
- •Subject has at least one adjacent tooth contact
排除标准
- •Subject has history of bruxism,
- •Subject has allergies to ingredients of glass ionomer based restorative materials.
- •Cavity/Caries has highly mineralized pigmented lesions, hypoplasia, fracture or cracks,
- •Subject has abrasion, erosion, abfraction,
- •Subject has fistula, abscess or pathological mobility,
- •Subject has pain, pulp exposure
结局指标
主要结局
Clinical success assessment measurement
时间窗: 12 months.
All restorations were evaluated by using Modified US Public Health Service criteria (modified USPHS criteria). Marginal Integrity (MI)), Marginal Discoloration (MD), Secondary Caries (SC), Anatomic Form (AF), and retention (R) were evaluated. A restoration was considered a failure when codes Charlie (C) and D (Delta) were registered. Codes A (Alpha) and B (Bravo) was considered a success or acceptable. follow up period was baseline, 6th months, 12th months.
次要结局
未报告次要终点