跳至主要内容
临床试验/CTRI/2025/04/084140
CTRI/2025/04/084140尚未招募4 期

Effectiveness of silver diamine fluoride (SDF) in arresting caries in 3-6 years old children - a community based randomised control trial.

Model rural health research unit1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2025年5月1日最近更新:

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

发起方
Model rural health research unit
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Dr Ajoy Kumar Shahi

Rajendra institute of medical sciences

研究点 (1)

Loading locations...

相似试验