Discoloration of Carious Primary Teeth After Application of Silver Diamine Fluoride Versus Sodium Fluoride Varnish: A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Discoloration
研究概览
简要总结
To assess discoloration of carious primary teeth after application of silver diamine fluoride versus sodium fluoride varnish.
详细描述
The American Academy of Pediatric Dentistry's (AAPD) guidelines (2017) stated that Silver diamine fluoride (SDF) is a brush-on liquid that arrest 87.7% of dental caries lesions. The success rate is similar for restorations placed under GA. One of the most exciting aspects of SDF is the 67±4% decrease in new lesions on untreated surfaces, achieved simply by treating active lesions .This is not the same as incidence of any new lesions (elaborated above for treatment under GA), however the relation warrants further investigation.
Benefit to the patient
- No pain and infection.
- Enhance child cooperation.
- Enhance better patient compliance.
- Decrease cost of dental treatment and may eliminate the need for General Anesthesia.
Benefit to the dentist
- Develop an effective fast easy method to arrest the caries by using SDF.
- Ease of dental treatment.
- Better cooperation with the child.
- The procedure is simple.
- Inexpensive and non-invasive.
- It does not require expensive equipment or support infrastructure, such as pipe water or electricity.
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
- Double (Participant, Outcomes Assessor)
盲法说明
double (participant-outcome assessor)
入排标准
- 年龄范围
- 1 Year 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children with carious primary teeth before eruption of permanent teeth
- •High caries risk patients with anterior or posterior carious lesions
- •Uncooperative children without access to or with difficulty accessing dental care.
排除标准
- •Children with spontaneous or elicited pain from caries
- •Tooth mobility
- •Signs of pulpal infection
- •Severe medical conditions that would not allow management in the clinic
研究组 & 干预措施
Group 1
38% silver diamine fluoride liquid will be applied twice annually and patients will be followed up as 0,1,3,6,9 and 12 SDF is brush on liquid
干预措施: Silver Diamine Fluoride (Drug)
Group 2
5% Sodium fluoride varnish will be applied four times annually and patient will be followed up at 0,1,3,6,9 and 12
干预措施: Sodium Fluoride Varnish (Drug)
结局指标
主要结局
Discoloration
时间窗: 12 months
Discoloration will be assessed by questioning the patient and/or the guardian.binary (yes or no)
次要结局
- Timing of discoloration(12 months)
- Postoperative Pain: Questioning the patient(12 months)
- Investigator reported discoloration(12 months)
- Caries arrest (dentine texture)(12 months)
- Parental satisfaction: Questioning the parent(12 months)
研究者
Yousra Mohamed
Principal investigator
Cairo University