Effectiveness of silver diamine fluoride (SDF) in arresting caries in 3-6 years old children - a community based randomised control trial.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- caries arrest in both experimental and control group
研究概览
简要总结
Rationale-- Traditional treatment approach of drill-and-fill", is associated with pain and fear for small age children. Traditionally, dental caries treatment requires surgical restorative approach, with sophisticated dental equipment and well-trained operators, and is relatively expensive. SDF offers an alternative innovative treatment option for caries. It is a practical, affordable, and acceptable option for caries treatment, eliminating the need for fear related dental treatment in young children, and can improve long-term oral health outcomes even at community level.
Novelty- This study is probably the first one to investigate the effectiveness of SDF 38% and GIC in arresting caries of young children of rural area at community level program. Due to the under-developed oral health care system at rural level, most of the decayed teeth in children remain untreated. Untreated dental caries in children can lead to problems with food intake, sleep, daily activities, and self-esteem. Caries arrest treatment with SDF is a non- invasive acceptable and affordable treatment option. Evidence that SDF is comparable in the treatment of dental caries in a school setting may substantially improve the reach and effectiveness of caries prevention as a dental public health intervention
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 3.00 Year(s) 至 6.00 Year(s)(—)
- 性别
- All
入选标准
- •At least one soft caries lesion, i.e, cavitated active caries lesion that is small in size (less than half of the mesial or distal or less than one-third of the buccal, lingual, or occlusal surfaces).
排除标准
- •Pulpal exposure, history of pain, nonvital teeth, swelling or fistula, silver allergy, arrested caries or inactive lesions, teeth at the period of shedding, restored teeth, secondary caries, fluorosis, enamel hypoplasia, uncooperative behavior, physical or mental disability, and a lack of signed informed consent.
结局指标
主要结局
caries arrest in both experimental and control group
时间窗: 6 months,12 months,18 months,24 months
次要结局
- complications associated with treatment(6 months,12 months,18 months,24 months)
研究者
Dr Ajoy Kumar Shahi
Rajendra institute of medical sciences
