Clinical Performance of Restorative Materials in Class II Cavities of Primary Molar Teeth
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Clinical evaluation of restorative materials in class II cavities on primary molar teeth according to the modified USPHS criteria
研究概览
简要总结
The purpose of this study is to evaluate and compare the clinical performance of dental restorative materials in Class II cavities of primary molar teeth
详细描述
Restorations will be placed on four primary molar teeth with proximal caries, in a split mouth design. 100 patients will be included in the study. The teeth will be randomized into four groups according to the restorative materials.
Group 1: Adhesive agent+ Compomer (Dyract AP, Dentsply DeTrey, Konstanz,Germany) Group 2: Primer + Resin modified glass ionomer (Vitremer, 3M ESPE, U.S.) Group 3: Adhesive agent + Giomer (Beautifil II, (Shofu Dental, Tokyo, Japan) Group 4: Amalgam (Permite amalgam, SDI Limited, Bayswater, Australia) The restorations will be evaluated at baseline, 3., 6., 12. months for the first year, and at every 6 months for 5 years. The modified US Public Health Service criteria (secondary caries, marginal integrity, marginal discoloration and retention) will be used for clinical evaluation of restorations. The data will be analysed statistically using Wilcoxon test, chi square test and the Kaplan-Meier survival method will be used to estimate survival percentages.
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 (Participant)
入排标准
- 年龄范围
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients and parent of the patients who accept to participate and sign the informed consent
- •Patients who have at least four first and/or second primary molars with proximal caries that require class II restorations
- •Teeth that have healthy lamina dura and periodontal ligament
- •Teeth that have caries lesions extending no more than the outher half of dentin radiographically
排除标准
- •Patients and parent of the patients who don't accept to participate and sign the informed consent
- •Teeth that are previously restored
- •Patients who are uncooperative
- •Teeth that doesn't have proximal or occlusal contacts with adjacent healthy teeth
- •Patients who have bruxism, skeletal or dental malocclusion
- •Teeth that have developmental defects or anomalies
结局指标
主要结局
Clinical evaluation of restorative materials in class II cavities on primary molar teeth according to the modified USPHS criteria
时间窗: 5 years
Long-term clinical success of different restorative materials in class II cavities on primary molar teeth
次要结局
未报告次要终点
研究者
Zafer Cavit Cehreli, DDS, PhD
Prof
Hacettepe University