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临床试验/CTRI/2025/08/093836
CTRI/2025/08/093836尚未招募3 期

Comparative evaluation of the effect of different anti-oxidants in reducing tooth discoloration caused by 38 percent silver diamine fluoride in primary molars- a randomized controlled trial

Ranjeet Deshmukh Dental College and research Centre1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2025年9月18日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
45
试验地点
1
主要终点
To evaluate and compare the effectiveness of anti-oxidants ALA and GSH with KI in reducing

研究概览

简要总结

A randomised controlled trial to evaluate and compare the effectiveness of antioxidants Alpha Lipoic Acid and Glutathione with Potassium Iodide in reducing discoloration caused by 38 percent Silver Diamine Fluoride in carious primary molars.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
3.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • The study will include healthy children aged 3 to 8 years with a Frankl behavior rating of 3 or
  • Selected teeth were primary molars presenting with occlusal carious lesions having an ICDAS score of 3, 4, or 5, with radiographic evidence of sound dentin.
  • Written informed consent was obtained from the parent prior to participation.

排除标准

  • The exclusion criteria will comprise medically compromised patients, those with thyroid gland disorders, individuals with a known history of allergy to silver, and highly uncooperative patients.

结局指标

主要结局

To evaluate and compare the effectiveness of anti-oxidants ALA and GSH with KI in reducing

时间窗: 4 weeks

discoloration caused by 38% SDF in carious primary molars.

时间窗: 4 weeks

次要结局

  • To assess if the reduction in discoloration is acceptable by parents.(1 week)
  • To evaluate the palatability of ALA, GSH & KI after application of 38 percent SDF.(1 week)

研究者

发起方
Ranjeet Deshmukh Dental College and research Centre
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Sheel Mate

Ranjeet Deshmukh Dental college and research centre

研究点 (1)

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