Efficacy of Silver Diamine Fluoride Versus Nano-Silver Fluoride in Arresting Active Dentin Caries in Primary Teeth in Young Children: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Caries arrest of active dentin caries
研究概览
简要总结
Early childhood caries is a major public health problem affecting preschool children worldwide. Silver Diamine Fluoride is a well-established non-invasive treatment for arresting caries; however, it causes black discoloration of treated lesions. Nano-Silver Fluoride has been introduced as an alternative that may arrest caries without discoloration.
This randomized clinical trial aims to compare the efficacy of Silver Diamine Fluoride and Nano-Silver Fluoride in arresting active dentin caries in primary teeth and to assess discoloration, post-operative pain, and parental satisfaction over a 12-month follow-up period.
详细描述
This randomized clinical trial will be conducted on 30 children aged 3-5 years attending the outpatient clinic of Pediatric Dentistry, Faculty of Dentistry, Suez Canal University. Children with active dentin caries in primary molars will be randomly allocated into two groups: Silver Diamine Fluoride group and Nano-Silver Fluoride group.
Both materials will be applied topically without caries excavation. Clinical evaluation will be performed at baseline and at 1, 3, 6, 9, and 12 months using ICDAS criteria, visual and tactile examination, assessment of post-operative pain, discoloration through standardized photographs, and parental satisfaction questionnaires.
The primary outcome is caries arrest. Secondary outcomes include discoloration, pain, and parental satisfaction.
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
- 3 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Apparently healthy children.
- •Children with age ranged from 3-5 years from both genders.
- •Children who refused dental treatment with Frankl Behavior Rating Scale 1 and
- •Children having molars with active dentin caries score (2,3,4) according to International Caries Detection and Assessment System- ICDAS II, detected by visual and tactile.
- •Parents/guardians accept treatment and write informed consent.
排除标准
- •Children with allergy to silver from their medical history.
- •Children with ulcerative gingivitis.
- •Children with primary molars with the following criteria:
- •Symptomatic
- •Involving the pulp
- •Presence of fistula or sinus
- •Presence of gingival inflammation and Pain on percussion
- •Close to exfoliation
研究组 & 干预措施
Arm A: Nano-Silver Fluoride
Topical application of Nano-Silver Fluoride varnish containing silver nanoparticles, chitosan, and fluoride applied to active dentin caries lesions in primary molars. Application will be performed twice: at baseline and after 6 months, without caries excavation or restoration.
干预措施: Nano-Silver Fluoride (Drug)
Arm B: Silver Diamine Fluoride
Topical application of 38% Silver Diamine Fluoride varnish applied to active dentin caries lesions in primary molars. Application will be performed twice: at baseline and after 6 months, without caries excavation or restoration.
干预措施: Silver Diamine Fluoride (Drug)
结局指标
主要结局
Caries arrest of active dentin caries
时间窗: 1, 3, 6, 9 and 12 months
Arrest of caries assessed clinically by hardness of dentin using blunt periodontal probe and ICDAS criteria
次要结局
- Discoloration of carious lesions(1, 3, 6, 9 and 12 months)
- Post-operative pain(1, 3, 6, 9 and 12 months)
- Parental satisfaction(1, 3, 6, 9 and 12 months)
研究者
khaled sayed
lecturer assistant at pediatric dentistry department- faculty of dentistry- October University for Modern Sciences and Arts -
October University for Modern Sciences and Arts