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临床试验/CTRI/2025/12/098940
CTRI/2025/12/098940尚未招募不适用

Comparative Evaluation Of Cariostatic Efficacy Of 5% Nano silver Fluoride,38% Silver Diamine Fluoride,5% Sodium Fluoride Varnish On Primary Teeth In Children Of Age Group 4 To 8 Years With Incipient Carious Lesions – An In-Vivo Randomized Clinical Trial

BHEEMA PRAVALIKA1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2025年12月22日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
140
试验地点
1
主要终点
Caries arrest rate measured by change in lesion hardness and color

研究概览

简要总结

Over the past two decades, dentistry has evolved significantly yet dental caries remains a prevalent chronic disease worldwide particularly among children. Factors such as poor oral hygiene dietary habits limited access to care and socioeconomic conditions contribute to its high occurrence. Many cavities go untreated due to the overwhelming demand for oral healthcare services. Minimally invasive cost-effective approaches are replacing traditional drilling and filling methods to arrest caries progression. A shift toward a medical model of caries management focusing on prevention and remineralization is essential. While fluoride-based treatments are widely used they require patient compliance and multiple applications. To address this, the present study aimed to compare and evaluate the cariostatic efficacy of 5% nanosilver fluoride 38% silver diamine fluoride 5% sodium fluoride varnish on primary teeth in children of age group 4 to 8 years with incipient carious lesions an Invivo randomized clinical study. Ethical clearance was obtained from the institutional review board before conducting the study. A total of 160 incipient lesions of primary teeth were included in the study. Children were randomly assigned to one of four groups Group I 5% nanosilver fluoride, Group II 38% silver diamine fluoride, Group III 5% sodium fluoride varnish and Group IV saline served as the control group. After obtaining the consent form from the parents Under a sterile condition topical fluoride application was done to individuals of respective groups. The evaluation of cariostatic efficacy in terms of depth size and sensitivity was assessed in four groups. The results were subjected to statistical analysis. It was observed that the superior efficacy of SDF and NSF in managing dental caries. While SFV offers temporary benefits its long-term efficacy is limited. Saline proved ineffective confirming the need for active intervention. SDF emerged as the most effective agent, followed closely by NSF making these treatments highly recommended for caries management.

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
4.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • Subject who is willing to participate in the study and has given written consent.
  • Children aged 4 to 8 years with incipient lesions or dental caries in primary teeth Absence of pulp involvement, pain, mobility, abscess, sinus, or fistula.
  • Participants should be free of any systemic diseases.

排除标准

  • Children whose parents refused to give consent Primary teeth with irreversible pulpitis Primary teeth which are close to exfoliation Children with fluorosis.

结局指标

主要结局

Caries arrest rate measured by change in lesion hardness and color

时间窗: Caries arrest rate measured by change in lesion hardness and color at 1 week 3 months | 6 months 9months 12months

次要结局

  • Parental satisfaction and child acceptance of treatment(Immediately post intervention)

研究者

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

BHEEMA PRAVALIKA

MNR DENTAL COLLEGE AND HOSPITAL

研究点 (1)

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