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临床试验/NCT05495373
NCT05495373已完成不适用

Can Saliva be the New Bio-fluid to Monitor Children's Oral Health?

Hadassah Medical Organization1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Periodontal status

研究概览

简要总结

Background: Salivary diagnosis is an emerging field; the potentially valuable biofluid contains many molecules of the systemic circulation. Still, its profile in health has been scarcely investigated.

Aim: This study aimed to characterize the inflammatory profile of healthy children's saliva, and to associate the parameters with clinical diagnoses of caries and gingival inflammation.

Study design: Unstimulated saliva was collected from 100 children who underwent clinical dental examinations. The saliva samples were analysed for total protein, specific cytokines (IL-10, IL-8, IL-6 and TNF- α) and bacteria using Bradford assay, ELISA and quantitative real-time polymerase chain reaction, respectively. Salivary values were analysed according to age, plaque index (PI) and gingival index (GI).

详细描述

Salivary diagnosis is an emerging field that has progressed through several important developments, including salivary proteome and the development of compact point-of-care devices for rapid analysis. Indeed, an increasing number of salivary markers have been identified; and some have been associated with cancer, cardiovascular diseases, autoimmune diseases, viral and bacterial diseases, and human immunodeficiency. Saliva is frequently studied due to the easy, non-invasive, and rapidly obtained collection, without the need for specialized equipment. Moreover, the prodigious fluid source of saliva provides many, if not most, of the molecules found in the systemic circulation, rendering it a potentially valuable bio-fluid for diagnoses.

Several types of inflammatory biomarkers associated with oral diseases, as well as systemic diseases, have been detected in saliva. Cytokines are among the most investigated biomarkers in this context. Due to their involvement in inflammatory, infectious and immunological diseases, cytokines may serve as markers of local oral pathologies such as periodontal disease and carries. Indeed, in adults, evidence shows that such disease can be detected through saliva biomarkers such as interleukins (IL)-1b, -6, -8 and -10), tumor necrosis factor- α (TNF- α) and matrix metalloproteinases (MMP)-8 and -9 in adults. Additionally, as some etiologies of oral pathology as gingivitis include bacterial infection such as Streptococcus, Fusobacterium, Actinomyces, Veillonella, Treponema, Capnocytophaga and Eikenella, saliva may also be used to measure bacterial load.

Dental caries is one of the most common childhood diseases worldwide, and is associated with polymicrobial colonization on tooth surfaces. Both acidogenic and aciduric bacteria, such as the Mutans group of Streptococci and Lactobacilli, are primary etiological agents of dental caries. Lactobacilli and S. Mutans are mostly found together in saliva . The diversity of microbes in saliva has been shown to increase in the caries active status. In children with cavitated carious lesions, altered concentrations of the cytokines IL-6 and IL-8 were reported.

The objective of this study was to characterize the inflammatory and microbiological profile of the saliva of healthy children, and to associate those levels with clinical diagnosis of caries and gingival disease.

Materials and methods Study population The study population comprised 100 participants, born during 2008-2016 (aged 4-12 years at the time of the study).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
4 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • healthy cases, no drug consumption or any chronic diseases. -

排除标准

  • antibiotics in last 6 months, during any medical treatment other than dental care.

结局指标

主要结局

Periodontal status

时间窗: at screening visit

measured by the gingival index (GI)

Oral hygiene

时间窗: at screening visit

measured by the plaque index (PI)

Caries status

时间窗: at screening visit

DMFT/ dmft index (D=decay, M=missing, F=filling; T per tooth) in permanent/ primary dentition

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Polak David

Principal Investigator

Hadassah Medical Organization

研究点 (1)

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