Comparative Study of Two Different Marketed Brands of Silver Diamine Fluoride SDF in Arresting Dental Caries in Children (Randomized Control Trial)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- o Arrest of caries
研究概览
简要总结
this study aims to evaluate two different materials used to stop dental caries in children. both materials are available at the market. both materials leave black stain after application. we follow up the patients for 1 year to evaluate which one is more effective in stopping dental caries.
详细描述
Before application of SDF, to protect the surrounding gingival tissues, cotton rolls will be used to minimize potential pigmentation. The lips and surrounded skin will also be protected using Vaseline. SDF in both groups will be applied directly to the affected tooth surface only, excess SDF will be removed with gauze, and finally the site will be isolated for up to three minutes.
All children will be recalled after 6 and 12 months for follow up.
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)
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children who are apparently healthy with primary carious teeth aged from 4-7 years.
- •Uncooperative children.
- •Children with financial barrier in accessing dental care
- •Clinically: absence of any pathology or pain except of sensitivity with eating.
- •Parents and patients accepting the new treatment modality and parents assigned the informed consent.
排除标准
- •Known sensitivity to silver or other heavy-metal ions.
- •Children who will not comply to recall program.
- •Teeth with pulp involvement.
- •Tooth mobility (more than grade 1 (grade 1:1-2 mm tooth mobility).
- •History of pain for a long period of time that may indicate chronic pulp inflammation.
研究组 & 干预措施
SDF, ToothMate®, Egypt.
Egyptian manufactured SDF, 38% silver diamine fluoride is applied. Before application of tooth mate SDF, to protect the surrounding gingival tissues, cotton rolls will be used to minimize potential pigmentation. The lips and surrounded skin will also be protected using Vaseline. Tooth mate SDF will be applied by bond brush directly to the affected tooth surface only, excess SDF will be removed with gauze, and finally the site will be isolated for up to three minutes.
All children will be recalled after 6 and 12 months for follow up
干预措施: SDF, ToothMate®, Egypt (Other)
SDF, ToothMate®, Egypt.
Egyptian manufactured SDF, 38% silver diamine fluoride is applied. Before application of tooth mate SDF, to protect the surrounding gingival tissues, cotton rolls will be used to minimize potential pigmentation. The lips and surrounded skin will also be protected using Vaseline. Tooth mate SDF will be applied by bond brush directly to the affected tooth surface only, excess SDF will be removed with gauze, and finally the site will be isolated for up to three minutes.
All children will be recalled after 6 and 12 months for follow up
干预措施: SDF, Advantage Arrest USA (Other)
SDF, Advantage arrest®, USA
USA manufactured SDF, 38% silver diamine fluoride. Before application of Advantage arrest SDF, to protect the surrounding gingival tissues, cotton rolls will be used to minimize potential pigmentation. The lips and surrounded skin will also be protected using Vaseline. Advantage arrest SDF will be applied by bond brush directly to the affected tooth surface only, excess SDF will be removed with gauze, and finally the site will be isolated for up to three minutes.
All children will be recalled after 6 and 12 months for follow up
干预措施: SDF, ToothMate®, Egypt (Other)
SDF, Advantage arrest®, USA
USA manufactured SDF, 38% silver diamine fluoride. Before application of Advantage arrest SDF, to protect the surrounding gingival tissues, cotton rolls will be used to minimize potential pigmentation. The lips and surrounded skin will also be protected using Vaseline. Advantage arrest SDF will be applied by bond brush directly to the affected tooth surface only, excess SDF will be removed with gauze, and finally the site will be isolated for up to three minutes.
All children will be recalled after 6 and 12 months for follow up
干预措施: SDF, Advantage Arrest USA (Other)
结局指标
主要结局
o Arrest of caries
时间窗: 12 months
Arrest of caries through: * tactile examination to assess hardness of treated lesions using gentle pressure with a probe, * color examination (yellow, brown or black
number of tooth with arrested caries in each group
时间窗: 12 months
Arrest of caries through: * tactile examination to assess hardness of treated lesions using gentle pressure with a probe, * color examination (yellow, brown or black)
次要结局
未报告次要终点
研究者
Rabab Mahmoud Abd Elhakam
Researcher of Pediatric Dentistry
National Research Centre, Egypt