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临床试验/CTRI/2025/02/079990
CTRI/2025/02/079990尚未招募Phase 3 4

Comparative evaluation of caries arrest potential of silver diamine fluoride gel with conventional solution form in primary teeth- A randomized controlled trial.

Dr. Ligam Padu1 个研究点 分布在 1 个国家目标入组 252 人开始时间: 2025年2月18日最近更新:

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

发起方
Dr. Ligam Padu
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Ligam Padu

All India Institute of Medical Sciences

研究点 (1)

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