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临床试验/NCT07414030
NCT07414030已完成不适用

Evaluation of the Relationship Between Salivary Antimicrobial Peptides and Severe Early Childhood Caries in Turkish Children

Bezmialem Vakif University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年7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
50
试验地点
1
主要终点
Salivary HST-5 Level

研究概览

简要总结

This observational study aims to evaluate the relationship between salivary antimicrobial peptides and severe early childhood caries (S-ECC) in Turkish children. Severe early childhood caries is a multifactorial disease influenced by microbial, environmental, and host-related factors. Salivary antimicrobial peptides play an important role in the innate immune defense of the oral cavity and may influence susceptibility to dental caries.

In this cross-sectional study, salivary samples were collected from children diagnosed with S-ECC and from caries-free controls. Clinical dental examinations were performed to assess caries status. The levels of selected salivary antimicrobial peptides were measured and compared between groups to determine potential associations.

The findings of this study may contribute to a better understanding of the role of salivary immune components in the development of severe early childhood caries.

研究设计

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

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

  • Case Group (S-ECC):
  • Preschool children aged 3-6 years
  • In the primary dentition period
  • No previous history of dental treatment
  • Diagnosis of severe early childhood caries (S-ECC) defined as:
  • dmft ≥4 at age 3, dmft ≥5 at age 4, dmft ≥6 at age 5
  • Systemically healthy children
  • Turkish ethnicity
  • Written informed consent obtained from parents or legal guardians
  • Control Group:
  • Preschool children aged 3-6 years
  • In the primary dentition period
  • No previous history of dental treatment
  • Caries-free children (dmft = 0)
  • No history of fillings or tooth extraction due to caries
  • Systemically healthy children
  • Turkish ethnicity
  • Written informed consent obtained from parents or legal guardians

排除标准

  • Use of medications affecting salivary flow within the last 3 months (e.g., antimuscarinic agents, antihypertensives, antidepressants)
  • Presence of systemic or local diseases affecting salivary secretion (e.g., diabetes, salivary gland infections, salivary gland stones, neurological disorders)
  • Lack of parental/legal guardian consent
  • Inability to cooperate during saliva sample collection
  • Presence of chronic systemic diseases
  • History of chemotherapy or radiotherapy

研究组 & 干预措施

Severe Early Childhood Caries (S-ECC)

Children diagnosed with severe early childhood caries based on clinical examination.

Caries-Free Control

Caries-free children without clinical signs of dental caries.

结局指标

主要结局

Salivary HST-5 Level

时间窗: At a single visit (baseline)

Quantitative level of histatin-5 (HST-5) measured in unstimulated saliva samples and compared between children with S-ECC and caries-free controls.

Salivary LL-37 Level

时间窗: At single visit (baseline)

Quantitative level of LL-37 measured in unstimulated saliva samples and compared between children with S-ECC and caries-free controls.

Salivary hBD-3 Level

时间窗: At a single visit (baseline)

Quantitative level of human beta-defensin 3 (hBD-3) measured in unstimulated saliva samples and compared between children with S-ECC and caries-free controls.

Salivary Antimicrobial Peptide Levels

时间窗: At single visit (baseline)

Quantitative levels of selected salivary antimicrobial peptides, including human beta-defensin 3 (HBD-3), histatin-5 (HST-5), and LL-37, measured in unstimulated saliva samples and compared between children with severe early childhood caries and caries-free controls.

次要结局

  • Streptococcus mutans Levels(At single visit (baseline))
  • Candida albicans Levels(At single visit (baseline))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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