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临床试验/CTRI/2024/08/072689
CTRI/2024/08/072689尚未招募3 期

Comparative Evaluation of Salivary Fluoride Concentration from Conventional Topical Fluoride Gel Application and Topical Fluoride Gel Infused via Iontophoresis among 8–12 Year Old Children: A Randomised Clinical Study.

DrJanvi Dave1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2024年8月28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
52
试验地点
1
主要终点
To evaluate Salivary

研究概览

简要总结

Fluorides have been at the forefront of preventive dentistry ever since their anticariogenic potential was discovered. Topical fluoridated products are able to create reservoirs, providing bioavailability of the product for the dental surface which is effective in reducing demineralization and increasing remineralization. Iontophoresis is a non-invasive technique, based on the application of a constant low-intensity electric current to facilitate the release of a variety of drugs, through the biological membranes. Iontophoresis enhances the delivery of both charged and uncharged drugs by the application of an electric current across a membrane. Iontophoresis has a wide range of application in dentistry, to produce a non-invasive technique of anaesthesia, iontophoresis of fluoride to decrease dentinal hypersensitivity, iontophoresis of peroxide for teeth whitening and that of nano-particles for re-mineralization of decalcified enamel and dentin are among the others. Fluoride levels in whole saliva can be affected by method of delivery, and generally follows the same pattern in plaque samples. Although salivary retention of fluoride does not necessarily reflect anticaries effect, this data can provide some indication of dose- effective methods of topical fluoride application. Barbakow in 19738 suggested that fluoride concentration were greater after the iontophoretic applications Recent invitro studies suggest tha there is increased uptake of fluoride in teeth after iontophoresis. Thus, it is vital to investigate improved fluoride administration systems.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Outcome Assessor Blinded

入排标准

年龄范围
8.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Children reporting to the Out-Patient- department accompanied by their parents within the age group of 8-12 years.Children with FRANKL’s 3 AND 4 behaviour rating scale will be included.Children with ICDAS score upto 2.

排除标准

  • Children who are medically compromised and those with special health care needs.Children with dental fluorosis.
  • Children with previous dental restorations.
  • Children who’s parents do not provide consent.

结局指标

主要结局

To evaluate Salivary

时间窗: Baseline, At 60 minutes, At 24 hours and At 1 week

level by infusing

时间窗: Baseline, At 60 minutes, At 24 hours and At 1 week

fluoride gel via

时间窗: Baseline, At 60 minutes, At 24 hours and At 1 week

Iontophorosis

时间窗: Baseline, At 60 minutes, At 24 hours and At 1 week

次要结局

  • To achieve more(efficient methods)

研究者

发起方
DrJanvi Dave
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Janvi Manish Dave

KM shah Dental College

研究点 (1)

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