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临床试验/NCT03360266
NCT03360266已完成不适用

Comparative Evaluation of Remineralizing Efficacy of Fluoride Varnish and Its Combination Varnishes on White Spot Lesions in Children With ECC: A Randomized Clinical Trial

Indira Gandhi Institute of Dental Science0 个研究点目标入组 60 人开始时间: 2016年3月21日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
主要终点
Dimension and Activity of white spot lesions.

研究概览

简要总结

The remineralizing efficacy of 3 fluoride varnishes were assessed in children with white spot lesion under 6 years of age ( children with early childhood caries)

详细描述

Early childhood caries (ECC) is the presence of 1 or more decayed (Non - Cavitated or Cavitated lesions), missing (due to caries) or filled tooth surface in any primary tooth in a child of 71 months of age or younger. In children younger than 3 years of age, any sign of smooth-surface caries is indicative of severe early childhood caries (S-ECC). It is a virulent form of caries, which develops on smooth surfaces and progresses rapidly. In children aged 12 to 30 months it initially affects the maxillary primary incisors and first primary molars, reflecting the pattern of eruption.

In ECC, the first clinical observation of demineralization in enamel is the white spot lesion, which is characterized by enamel demineralization of the subsurface, with increasing porosity due to the removal of minerals into the outer surface. At this stage, the caries lesion is usually reversible.

In young children, remineralization can be achieved by Non- invasive methods that are very effective. Fluoride prevents the caries process, leading to the formation of less soluble fluorapatite crystals. Among them, Topical fluorides are the most respected regimen. On application of topical fluorides to the teeth, calcium fluoride-like globules are formed on the tooth surface. These globules are effective mineral reservoirs that help prevent demineralization and promote remineralization by releasing calcium, phosphate and fluoride following acid attacks.

American Academy of Pediatric Dentistry (AAPD) recommends fluoride varnish in children. Randomized control trials have found it to be efficacious in primary teeth. Fluoride varnish can reverse or arrest caries lesions as well as prevent demineralization process of an incipient caries/white spot lesion, when combined with other preventive measures such as oral hygiene instructions & diet counseling.Children at increased caries risk should receive a professional fluoride treatment at least every six months. There is evidence from randomized controlled trials and meta-analyses that professionally applied topical fluoride treatments as five percent sodium fluoride varnish or 1.23 percent fluoride gel preparations are efficacious in reducing caries in children at caries risk.

Fluoride varnish works by increasing the concentration of fluoride in the outer surface of teeth, thereby enhancing fluoride uptake during early stages of demineralization. The varnish hardens on the tooth as soon as it contacts saliva, allowing the high concentration of fluoride to be in contact with tooth enamel for an extended period of time This is a much longer exposure compared to other high-dose topical fluorides such as gels or foams, with less risk of fluorosis even in children younger than 6 years.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

盲法说明

Investigator is masked in application of fluoride varnish and during all followup visits

入排标准

年龄范围
3 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Preschool children with ECC.
  • Children with active white spot lesions on labial surface of 1 or more primary maxillary anterior teeth.
  • Children whose parents signed the informed consent form/willing to participate in the study.
  • Apart from fluoride varnish and fluoridated tooth paste, subjects exposed to no other form of fluoride were included.

排除标准

  • Preschool children with cavitated lesions on primary maxillary anterior teeth.
  • Developmental enamel alterations (hypoplasia, fluorosis).
  • Children with systemic diseases.
  • Children with allergy to milk products.

研究组 & 干预措施

Enamel Pro

Experimental

Sodium Fluoride with ACP varnish (Enamel Pro varnish) applied over white spot lesions on maxillary anterior teeth

干预措施: Sodium Fluoride with CPP-ACP varnish (Combination Product)

Profluorid group

Active Comparator

5% Sodium Fluoride varnish (Profluorid varnish) applied over white spot lesions on maxillary anterior teeth

干预措施: Sodium Fluoride with CPP-ACP varnish (Combination Product)

Profluorid group

Active Comparator

5% Sodium Fluoride varnish (Profluorid varnish) applied over white spot lesions on maxillary anterior teeth

干预措施: sodium fluoride with ACP varnish (Combination Product)

Enamel Pro

Experimental

Sodium Fluoride with ACP varnish (Enamel Pro varnish) applied over white spot lesions on maxillary anterior teeth

干预措施: 5% Sodium Fluoride Varnish (Drug)

MI varnish

Experimental

Sodium Fluoride with CPP-ACP varnish (MI varnish) applied over white spot lesions on maxillary anterior teeth

干预措施: sodium fluoride with ACP varnish (Combination Product)

MI varnish

Experimental

Sodium Fluoride with CPP-ACP varnish (MI varnish) applied over white spot lesions on maxillary anterior teeth

干预措施: 5% Sodium Fluoride Varnish (Drug)

结局指标

主要结局

Dimension and Activity of white spot lesions.

时间窗: 6 months

The dimension of white spot lesions were measured with photographs using Adobe photoshop software. After prolonged air drying of 5 sec, the activity of white spot lesions were visualized using CPITN probe

次要结局

未报告次要终点

研究者

发起方
Indira Gandhi Institute of Dental Science
申办方类型
Other
责任方
Principal Investigator
主要研究者

DR.S.RADHA

Principal investigator

Indira Gandhi Institute of Dental Science

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