Comparison of Cariostatic Effect of Nano-Silver Fluoride Versus Silver Diamine Fluoride in a Group of Preschool Children
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- caries lesion activity and severity assessment using Nyvad criteria
研究概览
简要总结
This study will be conducted to test the cariostatic effect of Nano Silver Fluoride in a comparison to Silver Diamine Fluoride in a group of preschool children.
详细描述
Silver Diamine Fluoride has offered a non-invasive and easily performed method to manage dental caries in very young children.Studies shows that SDF has been proven to arrest caries in cavitated lesions and to prevent caries in sound teeth as Fluoride is effective in enhancing the remineralization of dental hard tissue and silver ion acts as an antibacterial agent. However, It was found that silver causes staining to the dental tissues with a black discoloration, which can be considered to be a main drawback specifically, when it is used on anterior teeth. Nano-silver fluoride varnish preparation showed high efficacy in arresting caries progression in primary teeth without causing black discoloration to the tissues.Silver diamine fluoride (SDF) .
Benefits for patient:
- Non-invasive treatment leading to reduce patient anxiety and stress.
- No drilling and filling.
- Protects against further caries progression.
Benefits for the practitioner:
- Provide alternative treatment options.
- Pain-free procedure that facilitates child management and saves time.
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 blinded study. Participants were blinded towards agents used in the study by using two identical squeezable plastic droppers with tag codes A and B. Also the bio-statistician will be blinded from the meaning of codes.
入排标准
- 年龄范围
- 3 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged from 3 to 5 years
- •clinical diagnosis of active dentinal caries in primary teeth
- •Co-operative participants and free of any systemic diseases
排除标准
- •Children whose parents refuse to sign consent
- •Primary teeth with pulp involvement, pain, mobility, abscess, sinus, fistula; or discoloration related to tooth non-vitality.
研究组 & 干预措施
Silver Diamine Fluoride
38% Silver Diamine Fluoride varnish
- the affected tooth will be cleaned by a disposable micro-brush for 30 seconds and then will be dried using cotton gauze sponges.
- No excavation will be done to the infected dentin tissue prior to the application of the agent.
- Gum will be protected with petroleum jelly, and isolation will be achieved by using cotton rolls.
- After isolation, a single drop SDF will be applied into the cavity by using a disposable micro-brush for at least two minutes. Then site of application will be covered with petroleum jelly.
- Finally, parents will be instructed that children participating in the trial are not allowed to eat or drink for one hour after application of the agent
干预措施: Silver diamine fluoride (Drug)
Nano-Silver Fluoride
Nano-Silver fluoride varnish preparation
- the affected tooth will be cleaned by a disposable micro-brush for 30 seconds and then will be dried using cotton gauze sponges.
- No excavation will be done to the infected dentin tissue prior to the application of the agent.
- Gum will be protected with petroleum jelly, and isolation will be achieved by using cotton rolls.
- After isolation, a single drop NSF will be applied into the cavity by using a disposable micro-brush for at least two minutes. Then site of application will be covered with petroleum jelly.
- Finally, parents will be instructed that children participating in the trial are not allowed to eat or drink for one hour after application of the agent
干预措施: Nano-Silver Fluoride (Drug)
结局指标
主要结局
caries lesion activity and severity assessment using Nyvad criteria
时间窗: 6 months
visual and tactile assessment for caries lesion to evaluate the caries progression using Nyvad classification - score from 0 ( normal enamel translucency and texture ) to 9 (carie lesion with filling )
次要结局
- ICDAS II(6 months)
研究者
Lara Abdelmoniem Mohamed
Pediatric dentist
Cairo University