CompletedNot Applicable

Salivary Antimicrobial Peptides and Severe Early Childhood Caries in Turkish Children

Turkey (Türkiye)50 participantsStarted 2024-07-01

Plain-language 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.

Who can participate

Age range

3 Years – 6 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Salivary Antimicrobial Peptide Levels

Timeframe: At single visit (baseline)

Trial details

NCT IDNCT07414030

SponsorBezmialem Vakif University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-09-30

View on ClinicalTrials.gov More Severe Early Childhood Caries trials