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Secondhand Smoke ExposureNCT06791707

Evaluation of Periodontal Health, Salivary Cotinine and S100A8/A9 Levels in Children Exposed to Passive Smoking

An observational study of Secondhand Smoke Exposure and Children, run by Cumhuriyet University at 1 site in Turkey (Türkiye).

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The periodontal health of children exposed to passive smoking will be evaluated by S100A8 and S100A9 levels. Read more about this study

Who is it for?
Ages 6 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Secondhand Smoke Exposure, Children, Inflamation
How many people
146 participants
Where
1 siteTurkey (Türkiye)
Study dates
24 Feb 2025to 19 Nov 2025
Phase
Observational
Are there results?
Not yet: the study is under way

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 6 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: All children were selected from patients referred to Sivas Cumhuriyet University, Faculty of Dentistry, and Department of Pediatric Dentistry.

Who may be able to join

  • Systemically and genetically healthy children

Who cannot join

  • Any medications known to affect defense system and periodontium
  • The presence of orthodontic / intraoral appliance

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Cumhuriyet University

    Sivas, 58140

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of Periodontal Health, Salivary Cotinine and S100A8/A9 Levels in Children Exposed to Secondhand Smoking

The periodontal health of children exposed to passive smoking will be evaluated by S100A8 and S100A9 levels.

Read the detailed description

Periodontal diseases are inflammatory conditions that affect the tissues supporting the teeth and occur through the interaction between dental plaque and the body's defense response. Microbial biofilm interacts with these tissues to trigger an immune response, and this process leads to changes in proteins, immunoglobulins, and inflammatory markers in the body. S100A8 and S100A9 proteins play an important role in the development of inflammation and are usually found in immune cells.

People exposed to passive smoking have a higher risk of developing periodontal disease. This is related to both microbial effects and changes in immune responses.

In this study, salivary levels of S100A8 and S100A9 proteins, which play a role in inflammation, will be evaluated to determine whether passive smoking increases the risk of periodontal disease in children. 146 children who apply to Sivas Cumhuriyet University Faculty of Dentistry for routine treatment will participate in the study. Their parents will be surveyed about demographic information and smoking habits, and children of parents who regularly smoke at home will be considered as passive smokers, while children of non-smoking parents will be considered as controls. Children who meet the inclusion criteria will be asked to spit into sterile polypropylene tubes for 5 minutes. The saliva flow rate (ml/min) will be measured from the obtained saliva samples and the saliva samples will be centrifuged at 6000 rpm for 10 minutes to remove cell debris. The supernatant phase will be transferred to Eppendorf tubes and stored at -80°C until analysis. Salivary cotinine and S100 A8/A9 levels will be measured using ELISA assay kits following the manufacturer's instructions. The periodontal status of the children will be determined by measuring the whole mouth plaque index (PI), gingival index (GI), probing depth (PD), and clinical attachment level (CAL). All measurements will be made with a dental loupe under 3.5 magnification to increase the accuracy of the data. The data obtained will be recorded on periodontal examination forms. All data obtained will be analyzed using SPSS 23.0 software package program (SPSS Inc., Chicago, IL, USA). Shapiro-Wilk test will be used to examine the normality of data distribution, T test and Mann-Whitney U test will be used to determine the differences between the groups in terms of normal and non-normal data, respectively. Correlations will be analyzed using Spearman's correlation analysis and p<0.05 will be considered significant. As a result of the analysis of the data, the effect of passive smoking on periodontal health in children will be evaluated by comparing the periodontal status and salivary S100A8/A9 and cotinine levels in children exposed to passive smoking and those not exposed.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06791707
Study groupRoleWhat they receive
Passive smoking-exposed childrenThis group consists of children whose family members have smoked at home since the birth of the child.
Passive smoking-unexposed childrenThis group consists of children whose family members have not smoked at home since the birth of the child.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Protein marker

    S100A8/A9 (pg/mL)

    Measured: Within 1 year

Secondary outcomes (1)
  1. Passive smoking measurement

    Cotinine (ng/mL)

    Measured: Within 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2025
  2. Study start24 Feb 2025
  3. Primary completion19 Sep 2025
  4. Study completion19 Nov 2025 (estimated)

Resources

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
146 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06791707
Sponsor's protocol ID
CumhuriyetU_ArzuKockanat_002
Status last verified
Jan 2025
First submitted
20 Jan 2025
Last updated
25 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kockanat A, Acipinar S. Salivary cotinine and S100A8/A9 levels in children exposed to environmental tobacco smoke: a case-control study. J Appl Oral Sci. 2026 May 15;34:e20250840. doi: 10.1590/1678-7765-2025-0840. eCollection 2026.

    PubMed 42154892

Questions about this trial

What is this clinical trial studying?

An observational study of Secondhand Smoke Exposure and Children, run by Cumhuriyet 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 1 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 25 Nov 2025. 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?

This study is still under way. Results are not available in the source record yet.

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?

Protein marker (time frame: Within 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06791707, which also lists 1 linked publication.

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 25 Nov 2025.

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