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临床试验/CTRI/2025/02/080119
CTRI/2025/02/080119尚未招募Unknown

Visual And Photographic Assessment Of Remineralizing Efficacy Of Self Assembling Peptide And Sodium Fluoride Varnish On White Spot Lesions In Primary Anterior Teeth: A Comparative Randomized Clinical Study.

Dr Shwetha N1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2025年2月15日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方
入组人数
46
试验地点
1
主要终点
1. increase or decrease in area of white spot lesion pre and post intervention.

研究概览

简要总结

Early childhood caries(ECC) is a biofilm-mediated, multifactorial, dynamic disease induced by the imbalance between demineralization and remineralization of dental hard tissues.1 Caries progress when the equilibrium of demineralization and remineralization is tilted, leading to net mineral loss and white spot lesion(WSLs) formation.2 Since a lower level of mineralization and the thin enamel make primary teeth more susceptible to caries formation, effective control of initial lesions before cavitation is of utmost importance.3

Remineralization of the initial lesion is always a viable option that arrests or reverses the caries process at a lesion level which reduces the loss of sound tooth structure.4 Sodium fluoride varnish(NaF) is a professionally used topical fluoride preparation that is simple, relatively inexpensive and effective in controlling the progression of WSLs.5 However, it has been claimed that the effect of fluoride is limited to the outer 30um and does not enter a deeper subsurface demineralized zone, where remineralization is much needed for the affected enamel.6

Owing to this limitation seeking an alternative that diffuses deeply into the subsurface caries in a biomimetic way similar to the natural remineralization could be valuable. One such is the Self-assembling peptide(SAP11-4) which mimics the action of natural enamel proteins that aid in guided enamel regenerartion.7 Several methods exist for the detection and assessment of WSLs, visual and tactile method is commonly used for detection and photography is simple and effective for assessment. There are limited clinical studies evaluating the efficacy of SAP11-4 and NaF on primary teeth, henceforth this study is undertaken.

研究设计

研究类型
Observational

入排标准

年龄范围
3.00 Year(s) 至 6.00 Year(s)(—)
性别
All

入选标准

  • • Co-operative children, aged 3-6 years with primary dentition .
  • • Teeth presenting at least one non-cavitated, active( whitish opaque appearance with rough surface), visible with or without air drying .
  • • The initial caries of ICDAS II score 1 or 2 on labial aspect of primary anterior teeth.
  • • Subjects with no systemic diseases or medications affecting salivary flow.
  • • Subjects with photographs of high image quality.

排除标准

  • • Subjects who had history of professional topical fluoride application or use of any remineralizing agents .
  • • Subjects who have GIC restorations adjacent to tooth with the white spot lesions .
  • • Subjects under tetracyclines or any other medications known to cause stains, had enamel hypoplasia, fluorosis or other developmental defects .

结局指标

主要结局

1. increase or decrease in area of white spot lesion pre and post intervention.

时间窗: 1 year 6 months

次要结局

  • change in appearence of white spot lesions in pre and post photographs(1year 6months)

研究者

发起方
Dr Shwetha N
申办方类型
Other [nil]
责任方
Principal Investigator
主要研究者

Dr Shwetha N

Government dental college and research institute

研究点 (1)

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