Randomized, Controlled Clinical Evaluation of Glass Ionomer System vs Composite Posterior Restorations

Hacettepe University2 个研究点分布在 1 个国家目标入组 54 人开始时间: 2009年5月1日最近更新: 2019年1月30日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Hacettepe University
入组人数: 54
试验地点: 2
主要终点: retention rate

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

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 9 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)

盲法说明

Double (Participant, Investigator)

入排标准

年龄范围: 20 Years 至 50 Years（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.

研究组 & 干预措施

EQUIA

Active Comparator

EQUIA Placing glass ionomer restorations, the dentin and enamel of cavities were conditioned with 20% polyacrylic acid for 20 seconds, washed, and briefly dried. Equia Fil was injected into the cavity. Isolation was maintained using cotton rolls and a saliva ejector. After the setting time of 2.5 minutes, the restoration was polished wet using high-speed fine diamonds. When the restoration was briefly dried, Equia Coat was applied and photocured for 20 seconds using a photo-curing light.

干预措施: EQUIA (Device)

Gradia Direct Posterior

Active Comparator

Gradia Direct Posterior The enamel and dentin were conditioned with G-Bond adhesive using a microtip applicator, left undisturbed for five to 10 seconds, and then dried thoroughly for five seconds with oil-free air under air pressure, Gradia Direct Posterior resin was applied with the incremental technique (2 mm thick layers) and light-cured for 20 seconds. Finally, the restoration was shaped with finishing diamonds and silicon instruments.

干预措施: Gradia Direct Posterior (Device)