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NCT Number: NCT06791707

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cumhuriyet University

Sivas, 58140, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Systemically and genetically healthy children

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Protein marker

    Time frame: Within 1 year

    S100A8/A9 (pg/mL)

Secondary outcomes

  1. Passive smoking measurement

    Time frame: Within 1 year

    Cotinine (ng/mL)

Sponsors and collaborators

Lead sponsor

Cumhuriyet University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 24, 2025
Registry last updated
Nov 25, 2025

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

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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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