Effectiveness of Silver Diamine Fluoride in Arresting Early Childhood Caries: Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- change in clinical success/failure rate
研究概览
简要总结
The study was conducted to evaluate the effectiveness of the biannual application of 38% silver diamine fluoride in arresting early childhood caries when compared to atraumatic restorative treatment.
详细描述
Owing to the virulent nature of early childhood caries (ECC) and its consequences if left untreated, immediate intervention is indicated to control the condition.
Barriers to intervention as young age, uncooperative patient behavior and lack of access to dental care are however, very common. The use of silver diamine fluoride as an anticaries agent is of growing popularity worldwide due to its promising results, safety of use, ease of application and relatively low cost. Further research is still required in order to provide evidence-based recommendations regarding the use of SDF in arresting early childhood caries. Purpose: To evaluate the effectiveness of biannual application of 38% silver diamine fluoride in arresting early childhood caries when compared to atraumatic restorative treatment.
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
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For children:
- •Healthy children.
- •Age range 2-5 years.
- •Informed consent (Appendix I)
- •Teeth with active dentin lesions corresponding to ICDAS II score 5 and
- •Teeth having lesions that are considered active according to ICDAS II activity criteria for coronal primary caries.
排除标准
- •For children:
- •Children with systemic diseases.
- •Children with reported allergy to silver or to any other component in the materials used.
- •Children unable to return for recall visits.
- •Clinical or radiographic signs of pulpal involvement.(pain, abscess, sinus, obvious discoloration, premature hypermobility, internal or external root resorption).
- •Teeth with inactive lesions.
研究组 & 干预措施
Silver Diamine Fluoride
- Gross debris will be removed with cotton pellets to allow better SDF contact with denatured dentin.
- Cotton rolls will be used to protect surrounding gingival tissues and mucous membranes to avoid pigmentation or irritation.
- Affected tooth surfaces will be dried with a gentle flow of air.
- 1-2 drops only of SDF will be used for the whole visit.
- SDF will then be directly applied to affected tooth surfaces only using a micro sponge brush.
- At least one minute will be needed to allow drying of SDF.
- Excess SDF will finally be removed with cotton rolls to minimize systemic absorption.
- When possible, isolation will be continued for up to three minutes.
- After 2-4 weeks: reapplication will be done only to lesions that do not appear arrested (dark and hard).
干预措施: SDF (Drug)
Atraumatic Restorative Treatment
Caries removal by hand instruments with care not to expose the pulp.
- Maximum excavation from the periphery of lesions will be done, to minimize leakage at the restoration margins.
- Cotton roll isolation will then be carried out.
- Cavities will be restored by glass ionomer cement.
- Hand pressure should be applied by a gloved and petroleum jelly coated finger, then, excess material will be removed.
干预措施: ART (Procedure)
结局指标
主要结局
change in clinical success/failure rate
时间窗: at 6 and 12 months
Treated teeth in both groups will be evaluated for clinical success in each follow up appointment. The number of clinically successful/failed teeth will be recorded in
次要结局
- Duration of the intervention visit(During the procedure)
- Patient Satisfaction(after the 4th week)
研究者
Hams Hamed Abdelrahman
Assistant lecturer
Alexandria University