Effectiveness of Silver Diamine Fluoride Versus Sodium Fluoride Varnish With Parental Behavior Modification for Arresting Early Childhood Caries: A Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Caries Arrest
研究概览
简要总结
Arresting dental caries using silver diamine fluoride (SDF) has gained attention recently for the management of early childhood caries (ECC). However, black staining is one of its drawbacks. A possible affordable alternative can be Sodium Fluoride (NaF) supported with good oral hygiene induced by parental Motivational Interviewing (MI).
The trial aims to compare the impact of SDF versus NaF supported by MI on lesion activity in preschool children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged ≤ 4 years old.
- •The presence of at least one active carious lesion on a primary tooth, with scores 3 and higher (according to the International Detection and Assessment System- ICDAS II)
- •Children whose caregivers have means of communication (mobile phones).
- •Completion of an informed consent to participate in the study.
排除标准
- •Children reporting spontaneous or elicited pain from caries or showing any signs of pulpal infection, swelling and/or abscess.
- •Parental refusal to participate in the study.
- •Allergy or sensitivity to silver or any of the materials included in the study.
研究组 & 干预措施
Naf + MI
Sodium Fluoride Varnish 5% (Applied biannually) + two MI sessions: baseline face-to-face session and phone call after 3months.
干预措施: Sodium Fluoride Varnish (5%) (Drug)
Naf + MI
Sodium Fluoride Varnish 5% (Applied biannually) + two MI sessions: baseline face-to-face session and phone call after 3months.
干预措施: Motivational Interviewing (Behavioral)
SDF
Silver Diamine fluoride 38% (Applied biannually)
干预措施: SDF (Drug)
结局指标
主要结局
Caries Arrest
时间窗: 6 months
Percentage of arrested carious lesions
次要结局
- Parental satisfaction(Baseline and 6 months)
- Caries Increment(6 months)
研究者
randa hassan abdelsamea yassin
Teaching Assistant
Alexandria University