Effect of Silver Diamine Fluoride Application on Oral Microbiome of Saudi Children: Randomized Clinical Trial in Jeddah City
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Arresting Effect
研究概览
简要总结
This clinical trial aims to learn more about the working mechanism of an antimicrobial agent used to manage dental caries, especially in young, uncooperative children. It will also provide a deeper insight into different products of the same agent and its effectiveness in Arresting dental caries.
The main questions it aims to answer are:
What is the clinical impact of silver diamine fluoride application in caries-active children? What is the antimicrobial effect of silver diamine fluoride in oral microbial inhabitants? Researchers will compare silver diamine fluoride (SDF)only and silver diamine fluoride+ potassium iodide(SDF+KI) to see which materials substantially affect on dental caries and oral microbial inhabitants
Participants/Parent will:
The parent will fill out a comprehensive data sheet for the child (childhood and current dental and medical history) Visit the dental clinic to Receive one of 2 (SDF or SDF+KI) treatment applications once Visit the clinic a 2nd time for a 2-4 week Treatment Follow-up Go through the sample collection process twice( pre- and 2-4 weeks post- Treatment) Sample collection including (Saliva- Biofilm and caries tissue sample)
详细描述
Aim of the Work
This study aims to:
- Evaluate the Arresting effect of 1-step (SDF only) versus 2-step (SDF+KI) application.
- Explore the effectiveness of SDF compared to SDF+KI on oral Microbiome.
- Evaluate and compare saliva composition before and after SDF application. Study Question What is the clinical and laboratory impact of silver diamine fluoride application in caries-active children? Research Null Hypothesis
- There is no difference in the Arresting effect of SDF versus SDF+KI application.
- There is no difference between the effectiveness of SDF versus SDF+KI application on oral Microbiome.
- There is no difference in in saliva composition before and after SDF
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
- None
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Presentation of irreversible pulpititis or necrosis• The extensive lesion was restored.
- •The surface of the lesion was hard and smooth.
- •Children with inherited or systemic conditions.
- •Children with a substantial medication history or those who have taken antibiotics within the previous three months.
- •Children who have undergone topical fluoride treatment within the previous 2 weeks.
研究组 & 干预措施
Arresting Treatment 1
Management of dental caries in children between the ages of 4 and 10 by arresting the lesion using standard Treatment for caries arrest, which is silver diamine fluoride %38
干预措施: Silver diamine Fluoride 38% (Drug)
Arresting Treatment 2
Management of dental caries n children between the ages of 4 and 10 by arresting the lesion using an alternative Treatment by using the combination of Silver diamine fluoride 38% + potassium iodide (SDF+KI), Both products reported as materials with an anti-microbial effect
干预措施: Silver diamine fluoride- potassium iodide (Drug)
结局指标
主要结局
Arresting Effect
时间窗: Baseline and follow up (after 2-4 weeks)
Arresting conditions (Arresting rate) will be assessed through clinical examination and intra-oral Photos evaluation of the cavities before and 2-4 weeks after SDF treatments * Caries activity status will be recorded as (active;1 or arrested;2) according to hardness and color (Caries activity status scored as 1: active or 2: arrested * Descriptive definition : * 1:Active lesion: tooth surface is deemed active if any softened area on the carious lesion is detected upon probing or no obvious changes in color, and the lesion is still soft. * 2:Arrested lesion: When the entire carious lesion is determined to be hard upon probing, or lesion is Darker in color and has hard surfaces (harder to excavate with a spoon excavator), it will be recorded as arrested caries.
次要结局
- Microbial status(Baseline and follow up (after 2-4 weeks))
研究者
Doaa Yasir Jamal
PhD candidate - Pediatric dental specialist
King Abdulaziz University