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.

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Key information

Conditions

Severe Early Childhood Caries Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bezmialem Vakif University Faculty of Dentistry, Department of Pediatric Dentistry

Istanbul, 34093, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Secondary outcomes

Streptococcus mutans Levels

Time frame: At single visit (baseline)

Quantitative assessment of Streptococcus mutans levels in saliva samples and comparison between study groups.
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.

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Feb 17, 2026
Registry last updated: Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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