Effectiveness of Silver Diamine Fluoride in Arresting Dental Caries in Deciduous Molars: a Controlled and Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 2
- 主要终点
- Caries arresting
研究概览
简要总结
The present study aims to evaluate, through a controlled clinical randomized study,the effectiveness of silver diamine fluoride in arresting dentin caries lesions in primary molars when compared to atraumatic restorative treatment.
详细描述
The present controlled clinical randomized study aiming at evaluating the effectiveness of silver diamine fluoride (SDF) in arresting dentin caries lesions on the occlusal surface of primary molars when compared to atraumatic restorative treatment (ART). For this, 118 healthy children aged 2-5 years with at least one active dentin carious lesion, with no signs of pain or pulp involvement. The participants will be allocated randomly to one of two treatment groups: (1) Test Group - SDF and (2) Control Group - ART. The International Caries Detection and Assessment System (ICDAS) will be used to determine caries diagnosis and activity. In both groups, the guardians and children will receive oral hygiene instructions and will be advised about eating habits and fluoride dentifrice use.The clinical success will be verified through examinations performed by a blinded operator, after 3, 6 and 12 months, with clinical evaluations to detect caries arresting, representing the primary outcome of the study.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged 2 to 5 years;
- •who are in good general health;
- •have at least one active dentin carious lesion on the occlusal surface of primary molars corresponding to ICDAS codes 5 or 6.
排除标准
- •with systemic or neurological diseases;
- •whose families intend to move from Rio de Janeiro next year;
- •with a history of allergy to silver or any substance present in the different materials to be used for treatment.
- •with spontaneous or provoked pain, dental mobility or radiographic signs of involvement or possible pulp involvement;
- •shows possible pulp involvement by radiographic examination
结局指标
主要结局
Caries arresting
时间窗: The follow-up oral examinations will be conducted every 3 months for 48 months totally
The main outcome of the study will be the observation of the proportion of arrested caries lesions in the test group, compared to the control group.
次要结局
- Cost(1 year)
- Aesthetic perception and treatment satisfaction(First appointment, 3,6 and 12 months after treatment.)
- Duration of the intervention visit(1 year)
- Quality of life assessment(First appointment,15 days and 3 months after treatment.)
- Anxiety(From allocation up to two weeks.)
研究者
Ana Lúcia Vollú
Postgraduate student,
Universidade Federal do Rio de Janeiro