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临床试验/NCT06957509
NCT06957509招募中不适用

Salivary Metaproteome as a Prediction Tool in Early Childhood Caries

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年4月4日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Differential protein expression across caries severity levels

研究概览

简要总结

The goal of this observational study is to learn if the composition of salivary proteins in 3-year-old children, from communities with documented varying caries risks, can be used to identify future diagnostic predictors for caries risk.

The main question to answer is:

• Can the host´s salivary protein profile (expression and abundance) show a correlation with the caries prevalence between the individuals in the different study cohorts?

Two cohorts of children with different documented demographic characteristics in the region of Stockholm (Sweden) will be examined.

Participants will be asked to provide saliva samples and undergo clinical oral examinations conducted by trained dental practitioners.

详细描述

Project summary

The term early childhood caries (ECC) describes the presence of one or more decayed, missing (due to caries) or filled primary teeth in children aged six years or younger. It has been shown that risk factors for ECC are frequent sugar consumption, inadequate oral hygiene as well as the colonization with cariogenic bacteria, such as the group of mutans streptococci, which are considered to be the main etiological agents of tooth decay in children. Other bacteria, such as Prevotella spp. and Lactobacillus spp., as well as fungus Candida albicans, were shown to be associated to the development and progression of ECC. Proteins in human saliva can influence the viability of oral microorganisms by various innate defense mechanisms, thus affect the composition of the oral microflora. Simultaneously bacteria are producing proteins to enhance various processes, e.g., the production of polysaccharides. While the word proteomics covers the exploration of all proteins from one species, metaproteomics relates to the investigation of proteins from microbial communities in interaction with the host, e.g. the host-microbiota crosstalk. Overall, the protein composition in young children's saliva, be it of microbial or human origin, could assist in biomarker implementation for early diagnosis as well as risk assessment of ECC.

This study aims to explore the overall salivary protein composition in cohorts of 3-year-old children from Swedish communities of varying risk for ECC, using high-throughput proteomics.

In brief, 50 3-year-old children will be recruited at two Public Dental Healthcare Centers, Folktandvården Danderyd and Folktandvården Järva, respectively. The project is structured in a clinical part (stage 1) and an analytical laboratory part (stage 2). Stage 1 will entail the recruitment of patients, the collection of saliva swab samples as well as the clinical examination, with particular emphasis on the presence of ECC. Stage 2 comprises the molecular analytical part during which the proteomic characterization of the saliva will take place. This molecular analytical part will be performed at the Department of Dental Medicine at Karolinska Institutet, with the support of the respective core facilities (Scaleless).

The investigators hypothesize that there are differential host proteomic and metaproteomic salivary profiles in ECC-affected children compared to caries-free children, and that these are associated with already identified risks for ECC posed between the two community-distinct cohorts.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

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

入选标准

  • •3-year-old children residing in the areas served by Folktandvården Danderyd and Järva, respectively
  • •Written consent, signed by both parents (guardians)

排除标准

  • •children older than three years
  • •medication intake, and antibiotic use at the time of examination
  • •children who have consumed food, drink, or used oral hygiene products within 2 hours before the dental visit
  • •children who appear uncooperative during saliva sampling

研究组 & 干预措施

C

children with clinically detectable caries (initial or manifest)

proteom Danderyd

proteome of 3-year-old children examined in Folktandvården Danderyd

proteom Järva

proteome of 3-year-old children examined in Folktandvården Järva

NC

caries-free children

结局指标

主要结局

Differential protein expression across caries severity levels

时间窗: up to 12 weeks

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

Franziska Hetrodt

Lecturer

Karolinska Institutet

研究点 (1)

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