Salivary Antimicrobial Peptides and Severe Early Childhood Caries in Turkish Children

NCT07414030 | Completed

• 1 other identifier: E.140950
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Severe Early Childhood Caries; Dental Caries

Outcome Measures

Primary Outcomes (1)

• Salivary Antimicrobial Peptide Levels

  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.

  At single visit (baseline)

Secondary Outcomes (2)

• Streptococcus mutans Levels

  At single visit (baseline)

• Candida albicans Levels

  At single visit (baseline)

Study Arms (2)

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.

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population consisted of systemically healthy Turkish children aged 3-6 years who attended the pediatric dentistry clinic. Participants were divided into two groups: children diagnosed with severe early childhood caries (S-ECC) and caries-free controls.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University Faculty of Dentistry, Department of Pediatric Dentistry

Istanbul, 34093, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Unstimulated whole saliva samples were collected for the analysis of salivary antimicrobial peptides and microbiological evaluation, including Streptococcus mutans and Candida albicans.

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 17, 2026
• Study Start: July 1, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

TU (1)