Clinical and Radiographic Evaluation After the Use of Silver Modified Atraumatic Restorative Treatment Versus Atraumatic Restorative Treatment in the Management of Occlusal Caries of Primary Molars in Preschool Children: Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Questioning parent about whether the child have pain between follow up intervals (provoked or spontaneous)
研究概览
简要总结
Silver modified atraumatic restorative treatment (intervention) or atraumatic restorative treatment (Control) will be used to manage occlusal caries in preschool children then the molars will be evaluated at the interval of 3,6 and 12 months clinically and 6 and 12 months radiographically
详细描述
Aim of the study:
To evaluate the clinical and radiographic outcomes after the use of silver modified atraumatic restorative treatment versus atraumatic restorative treatment in the management of occlusal caries in primary molars in preschool children.
PICO:
Population:
Preschool children (4-6 years) with occlusal caries in second primary molars.
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
- None
入排标准
- 年龄范围
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Patient and parent cooperation and compliance.
- •Children aged 4 - 6 years
- •Second primary molars with occlusal caries.
- •No clinical signs and symptoms of pulp involvement
- •No radiographic abnormalities
排除标准
- •• Uncooperative children or parents
- •Children with systemic diseases
- •Children with previous allergies to any of the used materials
研究组 & 干预措施
Silver modified atraumatic restorative treatment
Using silver diamine fluoride incorporated with atraumatic restorative treatment
干预措施: Silver modified atraumatic restorative treatment (Drug)
Atraumatic restorative treatment
Using atraumatic restorative treatment without the application of silver diamine fluoride
干预措施: Atraumatic restorative treatment (Other)
结局指标
主要结局
Questioning parent about whether the child have pain between follow up intervals (provoked or spontaneous)
时间窗: 12 months
Pain reported-Pain history that occurs after treatment at any point (will be recorded at the follow up intervals) Outcome will be binary (yes/no)
次要结局
- OHRQoL(oral health related to quality of life)(3 months)
- Questioning parents about their aesthetic perception(3 months)
- ART assessment criteria (Codes 00-90)(12 months)
- Caries density in radiograph(12 months)
研究者
Mennatallah Sameh Ahmed Farouk Abdelhamid
Principal investigator
Cairo University