Parental Perception of Silver Diamine Fluoride Staining and Its Efficacy on Caries Arrestment in Comparison to Sodium Fluoride With Casein Phosphopeptide-amorphous Calcium Phosphate
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- caries arrestment
研究概览
简要总结
This randomized clinical trial aims to compare the effectiveness of two topical fluoride application protocols, namely 38% silver diamine fluoride and sodium fluoride with added casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) in arresting dental caries in children.
详细描述
The present randomized clinical study is aiming to evaluate the effectiveness of silver diamine fluoride (SDF) in arresting dentin caries lesions when compared to MI Varnish a 5% sodium fluoride varnish which also contains RECALDENT™* (CPP-ACP): Casein Phosphopeptide-Amorphous Calcium Phosphate. For this, healthy children aged 4-8 years with at least one active dentin carious lesion will be allocated randomly to one of two treatment groups: Group (1) SDF and Group (2) MI Varnish. Each participant will be assigned to one treatment group to avoid the possible synergistic effect of the different agents.
Parents/ guardians of each child will be fully informed regarding the study design, objectives and probable advantages and side effects especially the black discoloration of SDF before their involvement by written consent. The International Caries Detection and Assessment System (ICDAS II) will be used to determine caries diagnosis and activity.visual and tactile examination will be done with a WHO probe to assess the primary outcome. the secondary outcome will be conducted by a questionnaire given to the parents.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal healthy children without any systemic disease ASA 1 physical status.
- •Children with at least one carious dentin lesion in their primary teeth, code 5 (ICDAS II)
排除标准
- •Children who suffer from major systemic diseases and require long term medications.
- •Children refuse the study intervention.
- •Children with silver or milk product sensitivity.
- •Presence of any gingival or perioral ulceration or stomatitis.
- •Tooth with abscess, fistula or severe pain.
研究组 & 干预措施
Group 1: topical application of silver diamine fluoride
38% silver diamine fluoride liquid
干预措施: silver diamine fluoride (Drug)
Group 2: topical application of MI varnish.
MI Varnish:5% sodium fluoride varnish which also contains RECALDENT™* (CPP-ACP): Casein Phosphopeptide-Amorphous Calcium Phosphate
干预措施: MI Varnish (Drug)
结局指标
主要结局
caries arrestment
时间窗: 2 weeks
The measure will be done using international caries detection and assessment system II (ICDAS II) criteria for diagnosing active and arrested caries by WHO probe
次要结局
- Parent perception(0 - 2 weeks)
研究者
Asmaa Mohammed Khammas
principle investigator
University of Baghdad