Severe Early Childhood CariesNCT07414030
Salivary Antimicrobial Peptides and Severe Early Childhood Caries in Turkish Children
An observational study of Severe Early Childhood Caries and Dental Caries, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Severe Early Childhood Caries, Dental Caries
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2024to 30 Sep 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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
Show all 18Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakif University Faculty of Dentistry, Department of Pediatric Dentistry
Istanbul, 34093
About this study
Official title: 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.
- Conditions
- Severe Early Childhood Caries, Dental Caries
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Salivary LL-37 Level
Quantitative level of LL-37 measured in unstimulated saliva samples and compared between children with S-ECC and caries-free controls.
Measured: At single visit (baseline)
Salivary hBD-3 Level
Quantitative level of human beta-defensin 3 (hBD-3) measured in unstimulated saliva samples and compared between children with S-ECC and caries-free controls.
Measured: At a single visit (baseline)
Salivary HST-5 Level
Quantitative level of histatin-5 (HST-5) measured in unstimulated saliva samples and compared between children with S-ECC and caries-free controls.
Measured: At a single visit (baseline)
Secondary outcomes (2)
Streptococcus mutans Levels
Quantitative assessment of Streptococcus mutans levels in saliva samples and comparison between study groups.
Measured: At single visit (baseline)
Candida albicans Levels
Quantitative assessment of Candida albicans levels in saliva samples and comparison between children with severe early childhood caries and caries-free controls.
Measured: At single visit (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start1 Jul 2024
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Early Childhood CariesStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07414030
- Sponsor's protocol ID
- E.140950
- Status last verified
- Aug 2026
- First submitted
- 10 Feb 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Salivary Antimicrobial Peptides and Severe Early Childhood Caries in Turkish Children
- ClinicalTrials.gov ID
- NCT07414030
- Acronym / sponsor ID
- E.140950
- Conditions
- Severe Early Childhood Caries, Dental Caries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Salivary LL-37 Level
Time frame: At single visit (baseline)
Quantitative level of LL-37 measured in unstimulated saliva samples and compared between children with S-ECC and caries-free controls.
Salivary hBD-3 Level
Time frame: At a single visit (baseline)
Quantitative level of human beta-defensin 3 (hBD-3) measured in unstimulated saliva samples and compared between children with S-ECC and caries-free controls.
Salivary HST-5 Level
Time frame: At a single visit (baseline)
Quantitative level of histatin-5 (HST-5) measured in unstimulated saliva samples and compared between children with S-ECC and caries-free controls.
2 secondary outcomes
Streptococcus mutans Levels
Time frame: At single visit (baseline)
Candida albicans Levels
Time frame: At single visit (baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Early Childhood Caries and Dental Caries, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary LL-37 Level (time frame: At single visit (baseline)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.