- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07414030
Salivary Antimicrobial Peptides and Severe Early Childhood Caries in Turkish Children
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
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Istanbul, Turkey (Türkiye), 34093
- Bezmialem Vakif University Faculty of Dentistry, Department of Pediatric Dentistry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Severe Early Childhood Caries (S-ECC)
Children diagnosed with severe early childhood caries based on clinical examination.
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Caries-Free Control
Caries-free children without clinical signs of dental caries.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Salivary Antimicrobial Peptide Levels
Time Frame: At single visit (baseline)
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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.
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At single visit (baseline)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Streptococcus mutans Levels
Time Frame: At single visit (baseline)
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Quantitative assessment of Streptococcus mutans levels in saliva samples and comparison between study groups.
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At single visit (baseline)
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Candida albicans Levels
Time Frame: At single visit (baseline)
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Quantitative assessment of Candida albicans levels in saliva samples and comparison between children with severe early childhood caries and caries-free controls.
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At single visit (baseline)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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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