Comparative evaluation of caries arrest potential of silver diamine fluoride gel with conventional solution form in primary teeth- A randomized controlled trial.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 252
- 试验地点
- 1
- 主要终点
- To compare and evaluate the caries arrest potential of
研究概览
简要总结
Thirty-eight percent silver diamine fluoride (SDF) has been found to arrest carious lesions, but multiple applications are more effective than a single treatment. Although safe, the liquid form of SDF is difficult to control in young children, increasing the possibility of inadvertent exposure of the soft tissues. Moreover, SDF solution is bitter and has a metallic taste, and children who have many teeth to be treated may respond negatively to the taste. A gel version of 38% SDF became available in the United States in early 2023 and in 2022 in India. A few in vitro studies using SDF gel have been reported in the literature. SDF gel has been shown to exhibit less cytotoxic effect compared to Kidz-e and Fagamin and can be considered the best choice for arresting caries in primary and permanent teeth. To date, the clinical studies on dental caries arrest potential of SDF gel are limited. Also, the clinical/in-vivo studies comparing the caries arrest potential of novel silver diamine fluoride gel with conventional solution in primary teeth are scarce. Hence, this study is planned to compare caries arrest potential between the SDF gel and the solution form on the dentinal lesions in primary teeth in children
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 8.00 Year(s)(—)
- 性别
- All
入选标准
- •1-Healthy children from the age of 4-8 years 2-Child having at-least one asymptomatic active cavitated lesion in primary tooth 3-Children whose cooperation level is scored as positive or definitely positive as per Frankl Behaviour Rating Scale.
排除标准
- •1-Teeth with pain, or any other symptoms suggestive of pulpitis 2-Teeth with signs of irreversible of irreversible pulpitis (spontaneous pain, abscess, pathological mobility) 3-Teeth suggesting signs of non-vital pulp.
- •4-Children having significant chronic systematic condition or taking long term medication that may affect oral health 5-Children whose parents don’t give consent for the SDF application 6-Children with known allergy to silver.
结局指标
主要结局
To compare and evaluate the caries arrest potential of
时间窗: Baseline, 1 month, 6 month, 12 month
novel Silver Diamine Fluoride gel and Conventional SDF
时间窗: Baseline, 1 month, 6 month, 12 month
solution in cavitated carious lesions in primary teeth
时间窗: Baseline, 1 month, 6 month, 12 month
次要结局
- 1-To compare the taste acceptability of the patient(2-Parental acceptance level)
研究者
Dr Ligam Padu
All India Institute of Medical Sciences
