Effectiveness of Silver Diamine Fluoride as Cavity Disinfectant After Atraumatic Restorative Treatment in Primary Teeth: A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Microbiological assessment of total viable bacterial count
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of silver diamine fluoride (SDF) compared to chlorhexidine (CHX) as a cavity disinfectant in primary molars after Atraumatic Restorative Treatment approach (ART).
详细描述
This study is a three arm randomized controlled clinical trial, where children with an age range of 4-6 years indicated for Atraumatic Restorative Treatment (ART) are selected from the outpatient clinic of Pediatric Dentistry and Public Health Department, Faculty of Dentistry, Alexandria University after securing necessary consents. Sixty teeth are randomly allocated into 3 groups of Atraumatic restorative treatment approaches. Group I is assigned to silver diamine fluoride as an antibacterial agent, Group II is assigned to chlorhexidine as an antibacterial agent, and Group III serves as a negative control.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The operator will not be blinded to the type of treatment as each antibacterial agent has different consistency, color and application technique. However the expert assessing the microbiologic sample and statistician will be blinded to the treatment groups.
入排标准
- 年龄范围
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children free of any systemic disease or special health care needs.
- •Class I cavity involving dentin in primary molars.
- •Lesion wide enough to allow access of instruments.
- •Informed consent fulfilled.
排除标准
- •Signs of irreversible pulpitis or pulp necrosis.
- •Patients allergic to silver products.
研究组 & 干预措施
Silver Diamine Fluoride (SDF) group
Atraumatic restorative technique will be performed. Then the cavities will be dried with a gentle flow of compressed air. One drop of silver diamine fluoride (Advantage Arrest Silver Diamine Fluoride 38% - Bottle) will be dispensed into a dappen dish. A micro brush will be bent, dipped into SDF and dabbed on the side of the dappen dish to remove excess liquid before application. SDF will be applied directly to affected tooth surface and dried with gentle flow of compressed air for 1 minute. Excess SDF will be removed with cotton roll. Teeth will be restored with glass ionomer cement (GC Fuji IX).
干预措施: Silver Diamine Fluoride (Drug)
Chlorhexidine group
Atraumatic restorative treatment will be performed. Then, the cavities will be disinfected by placing a cotton pellet soaked in chlorhexidine solution (Consepsis®2% Chlorhexidine Antibacterial Solution) for 1 minute, air dried and restored using glass ionomer cement.
干预措施: Chlorhexidine (Drug)
Atraumatic Restorative Treatment without Disinfection
Cavities will be cleaned according to the ART approach.The cavity will be enlarged if needed using sterile hatchet.The carious dentin will be removed with excavators starting at the enamel-dentine junction. The unsupported thin enamel will be fractured off with the hatchet. The caries will be removed carefully until firm dentin is reached (physically resistant to hand excavation). The cavity will be cleaned with wet cotton pellets. Cavities will be restored immediately using conventional glass ionomer cement. All the cavities in the 3 groups will be temporary restored with glass ionomer cement handled according to manufacturer's instructions, however acid etching will not be carried out in order to make sample collection easier following the experimental period.
干预措施: Atraumatic Restorative Treatment without Disinfection (Procedure)
结局指标
主要结局
Microbiological assessment of total viable bacterial count
时间窗: First day (baseline)
The first dentin sample will be collected with a sterile spoon excavator from the firm dentin in the center of the cavity. Two microliters of the samples collected will be inoculated on blood agar for total viable count.
Change in the total viable count.
时间窗: 14 days
A second dentin sample will be taken from the same position with a sterile round bur for bacteriologic assessment.
Change in the lactobacilli count.
时间窗: 14 days
A second dentin sample will be taken from the same position with a sterile round bur for bacteriologic assessment.
Change in the streptococcus mutans count.
时间窗: 14 days
A second dentin sample will be taken from the same position with a sterile round bur for bacteriologic assessment.
Microbiological assessment of streptococcus mutans count
时间窗: First day (baseline)
The first dentin sample will be collected with a sterile spoon excavator from the firm dentin in the center of the cavity. Two µl of the samples will be inoculated on mitis salivarius agar supplemented with 15 percent sucrose and bacitracin (0.2 U/ml) for selective isolation of Streptococcus mutans.
Microbiological assessment of lactobacilli count
时间窗: First day (baseline)
The first dentin sample will be collected with a sterile spoon excavator from the firm dentin in the center of the cavity.Two µl of the samples will be inoculated on Rogosa agar, a medium selective for Lactobacilli.
次要结局
- Clinical changes in the dentin consistency(14 days)
- Clinical changes in the dentin color(14 days)
研究者
Nourhan M.Aly
Clinical Instructor and statistician
University of Alexandria