Salivary Antimicrobial Peptides and Severe Early Childhood Caries in Turkish Children

February 10, 2026 updated by: Bezmialem Vakif University

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

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.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Istanbul, Turkey (Türkiye), 34093
        • Bezmialem Vakif University Faculty of Dentistry, Department of Pediatric Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Salivary Antimicrobial Peptide Levels
Time Frame: 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.
At single visit (baseline)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Streptococcus mutans Levels
Time Frame: At single visit (baseline)
Quantitative assessment of Streptococcus mutans levels in saliva samples and comparison between study groups.
At single visit (baseline)
Candida albicans Levels
Time Frame: At single visit (baseline)
Quantitative assessment of Candida albicans levels in saliva samples and comparison between children with severe early childhood caries and caries-free controls.
At single visit (baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Actual)

September 30, 2024

Study Completion (Actual)

September 30, 2024

Study Registration Dates

First Submitted

February 10, 2026

First Submitted That Met QC Criteria

February 10, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • E.140950

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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