Phase 1 Study of Clinical and Radiographic Success of Antibacterial Cement in Infected Dentin of Deciduous Teeth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- number of successful restorations with a dental liner with antibiotics
研究概览
简要总结
Dental materials with antibacterial properties can prevent the harmful effects caused by oral cariogenic bacteria. This double-blind controlled clinical trial evaluated the performance of antibacterial cement for sealing infected dentin in atraumatic restorations of primary molars.
详细描述
The study enrolled 45 children (45 teeth) between 5 and 8 years of age, of both genders, divided into two groups. In group A (GA; n=22), the cavities were lined with conventional glass ionomer cement (Vidrion F®) and in group B (GB; n=23), with antibacterial cement (Vidrion F® containing 1% each of metronidazole, ciprofloxacin, and cefaclor). Both groups were restored with Ketac Molar Easymix®. Molars with carious lesions on the inner half of dentin without clinical or radiographic pulp damage were selected. Patients were evaluated clinically (for pain, fistulas, or mobility) and radiographically (area of caries, periapical region, and furcation of teeth) after 1, 3, 6, and 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signed consent from a parent or guardian;
- •primary molars with carious lesions on the inner half of dentin;
- •access of caries lesions to dentin spoons.
排除标准
- •damaged pulp determined clinically (for pain, fistulas, tooth mobility);
- •damaged pulp determined radiography (bone or dental pathology);
- •children taking antibiotics;
- •children who refused the treatment;
- •children had systemic disease.
结局指标
主要结局
number of successful restorations with a dental liner with antibiotics
时间窗: differences of overall success between baseline and the evaluations performed at 1, 3, 6, and 12 months.
The absence of pain, fistulas, and mobility throughout the study was considered clinical success and the decreased or unchanged area of caries (obtained by a software to accurately measure distances between anatomical points selected by the operator of radiolucent zone beneath the restoration) and no bone or dental disorder was detected was considered radiographic success. Overall success was defined as clinical and radiographic success being achieved simultaneously.
次要结局
未报告次要终点
研究者
Jainara Maria Soares Ferreira
Principal investigator
University of Pernambuco