Randomized, Controlled Trial of Glass Ionomer System vs Composite Posterior Restorations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 主要终点
- Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding anatomic form.
研究概览
简要总结
The aim of this clinical trial was to compare the clinical performances of a glass ionomer restorative system with a micro hybrid resin based composite in class I and class II cavities. A total of 140 (80 class I and 60 class II) lesions in 59 patients were restored with a glass ionomer restorative system (Equia) or a micro hybrid composite(Gradia Direct). Restorations were evaluated at baseline and yearly during 6 years according to the modified-USPHS criteria. Data were analyzed with Cohcran's Q and McNemar's tests (p<0.05).
详细描述
Since the introduction of glass ionomers many modifications of these materials have been performed over the years. Compared to other permanent filling materials like resin-based composites, glass ionomers show several advantages, such as the ability to adhere to moist enamel and dentin and anti-cariogenic properties such as the long-term fluoride release. So, it was doubtful that glass ionomers represent a capable counterpart of amalgam or resin-based composites in posterior teeth.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 15 Years 至 37 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •a need for at least two but not more than four posterior toothcolored restorations;
- •the presence of teeth to be restored in occlusion;
- •teeth that were symptomless and vital;
- •a normal periodontal status;
- •a good likelihood of recall availability.
排除标准
- •partly erupted teeth;
- •absence of adjacent and antagonist teeth
- •poor periodontal status;
- •adverse medical history;
- •potential behavioral problems.
结局指标
主要结局
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding anatomic form.
时间窗: From baseline to 6 year the change of restorations was evaluated
Anatomic form was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha 1: Continuous with existing anatomical form Alpha 2: Slightly discontinuous due to some chipping on the proximal ridge Bravo: Discontinuous with existing anatomical form due to material loss but proximal contact still present Charlie: Proximal contact is lost with ridge fracture.
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal discoloration.
时间窗: From baseline to 6 year the change of restorations was evaluated
Marginal discolouration was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha: No discoloration anywhere along the margin between the restoration and the adjacent tooth. Bravo: Slight discoloration along the margin between the restoration and the adjacent tooth. Charlie: The discoloration penetrated along the margin of the restorative material in a pulpal direction.
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding color change.
时间窗: From baseline to 6 year the change of restorations was evaluated
Colour changes was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha: The restoration matches the adjacent tooth structure in color and translucency. Bravo: Light mismatch in color, shade or translucency between the restoration and the adjacent tooth. Charlie: The mismatch in color and translucency is outside the acceptable range of tooth color and translucency.
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate.
时间窗: From baseline to 6 year the change of restorations was evaluated
Retention rate was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C and D score means that the restoration has failed and needs to be replaced. Alpha 1:Clinically excellent Alpha 2: Clinically good with slight deviations from ideal performance, correction possible without damage of tooth or restoration Bravo: Clinically sufficient with few defects, corrections or repair of the restoration possible Charlie: Restoration is partially missed Delta: Restoration is totally missed
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal adaptation.
时间窗: From baseline to 6 year the change of restorations was evaluated
Marginal adaptation was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C and D score means that the restoration has failed and needs to be replaced. Alpha 1: Harmonious outline Alpha 2: Marginal gap (max 100µ) with discoloration (removable) Bravo: Marginal gap (\> 100µ) with discoloration (unremovable) Charlie: The restoration is fractured or missed.
次要结局
未报告次要终点
研究者
Zeynep Bilge Kutuk
Research assistant
Hacettepe University