The Effect of Silver Diamine Fluoride (SDF) on Bacteria Involved in Root or Cervical Carious Lesions Using HOMINGS Technology. A Clinical Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Change in Bacterial Composition Before and One Month After SDF Application to Root or Cervical Caries Lesions
研究概览
简要总结
The study will compare bacteria levels in cavities before and after silver diamine fluoride (SDF) treatment.
详细描述
To assess the effect of silver diamine fluoride (SDF) treatment on microorganisms present in root caries or cervical lesions by collecting microbial deposits before and 1 month after SDF application. Bacterial samples will be collected from 20 adult subjects at the initial visit before application of SDF and one month after. At the 1 month recall, examination for caries arrest will be performed. All 40 bacterial samples will be sent to the Forsyth Institute to verify bacterial composition using HOMINGS technology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Generally healthy adult participants 18 years of age and older.
- •At least one tooth with active (soft) cavitated lesions of ICDAS score 5 or 6 near the gingival margin (coronal cervical caries at the CEJ or exposed root surfaces with soft active carious lesions exposing dentin).
排除标准
- •Adult participants who suffer from serious life-threatening medical diseases that interfere with basic daily self care activities.
- •Patients taking antibiotics within the last two weeks.
- •Patients using chlorhexidine or fluoride mouth washes within the last two weeks.
- •Pregnant or breastfeeding women.
- •Teeth with arrested (hard) cervical or root caries lesions.
- •Teeth that have been diagnosed with an abscess or an irreversible pulpitis, or are mobile.
结局指标
主要结局
Change in Bacterial Composition Before and One Month After SDF Application to Root or Cervical Caries Lesions
时间窗: baseline, One month after SDF
Using human oral microbiome identification using next-generation sequencing (HOMINGS), change in the total bacterial composition of all subjects was measured by the difference of the number of bacteria count from baseline to one month after SDF application.
Caries Arrest of Teeth Measured by Change in Dentin Texture (Soft, Hard)
时间窗: One month
Caries were examined for hardness or softness before and after SDF application. The change in the texture was examined after one month of SDF application the change from soft to hard is noted below.
次要结局
- Patient Assessment of Appearance of Treated Tooth (Concern With the Appearance of Study Tooth, Desire for the Study Tooth to be Filled)(One month)
研究者
Heba Mitwalli
DDS, Master's Student
University of Michigan