Clinical Performance of Glass Ionomer Versus Resin Composite Restorations Performed Without Rubber-Dam Isolation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 主要终点
- Recurrence of caries
研究概览
简要总结
The aim of this randomised-controlled, single-blind, split-mouth, and single-centre clinical trial was to evaluate the 2-year clinical performances of a high-viscosity glass ionomer and nanohybrid composite resin in occlusal restorations on mandibular second molar teeth in patients at risk for salivary contamination.
详细描述
Occlusal carious lesions on the right and left mandibular second molars of 56 patients (26 females, 30 males) were restored in a split-mouth design. A high-viscosity glass ionomer (Hv-GIC) (Equia, GC) was used to restore the carious lesions in patients in the treatment group, while a nano-hybrid composite resin (GSO) (GrandioSO, Voco) was used for patients in the control group. Clinical evaluations of the restorations were performed at 1-week, 6-month, 1-year, and 2-year follow-up appointments, according to the FDI criteria. Data were analysed using the Friedman's analysis of variance and Mann-Whitney U tests (α=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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •good health and oral hygiene,
- •occlusal carious lesions on both mandibular second molars,
- •mandibular second molars with mesial and occlusal contacts,
- •contraindication to the use of rubber dam,
- •the ability to return for periodic follow-up visits.
排除标准
- •restoration on mandibular second molars.
结局指标
主要结局
Recurrence of caries
时间窗: Changes of dental restorations regarding recurrence of caries were observed at 1-week, 6-month, 1-year, and 2-year results were compared between two restorative material and change of material suring the study is observed
Recurrence of caries were observed by visual examination of two examiners. Restorations were scored 1 to 5 according to FDI criteria (1. No secondary or primary caries 2. Small and localized. 3 Larger areas of 1. Demineralisation 2. Erosion or 3. Abrasion/abfraction, dentine not exposed Only preventive measures necessary 4. Caries with cavitation and suspected undermining caries Localized and accessible can be repaired, 5. Deep caries or exposed dentine that is not accessible for repair of restoration.)
Staining restoration surface and restoration margin
时间窗: Changes of dental restorations regarding surface lustre were observed at 1-week, 6-month, 1-year, and 2-year results were compared between two restorative material and change of material suring the study is observed
Surface lustre of dental restorations were observed by visual examination of two examiners. Restorations were scored 1 to 5 according to FDI criteria (1. No surface staining, no marginal staining, 2. Minor surface staining, minor marginal staining easily removable by polishing, 3. oderate surface staining and moderate marginal staining that may also present on other teeth, not esthetically unacceptable, 4. Unacceptable surface staining on the restoration and major intervention necessary for improvement and Pronounced marginal staining; major intervention necessary for improvement, 5. Severe surface staining and/or subsurface staining, generalized or localized, not accessible for intervention and deep marginal staining, not accessible for intervention.).
Surface lustre of dental restorations
时间窗: Changes of dental restorations regarding surface lustre were observed at 1-week, 6-month, 1-year, and 2-year results were compared between two restorative material and change of material suring the study is observed
Surface lustre of dental restorations were observed by visual examination of two examiners. Restorations were scored 1 to 5 according to FDI criteria (1. Lustre comparable to enamel, 2. Slightly dull, not noticeable from speaking distance, 3.Dull surface but acceptable if covered with film of saliva, 4. Rough surface, cannot be masked by saliva film, simple polishing is not sufficient. Further intervention necessary, 5. Very rough, unacceptable plaque retentive surface.).
Fracture of material and retention
时间窗: Changes of dental restorations regarding Fracture of material and retention were observed at 1-week, 6-month, 1-year, and 2-year results were compared between two restorative material and change of material suring the study is observed
Fracture of material and retention of dental restorations were observed by visual examination of two examiners. Restorations were scored 1 to 5 according to FDI criteria (1. No fractures / cracks, 2. Small hairline crack. 3. Two or more or larger hairline cracks and/or material chip fracture not affecting the marginal integrity or approximal contact, 4. Material chip fractures which damage marginal quality or, approximal contacts. 5. (Partial or complete) loss of restoration or multiple fractures.).
次要结局
未报告次要终点
研究者
Huseyin Hatirli
Assistant Professor
Tokat Gaziosmanpasa University