- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06791707
Evaluation of Periodontal Health, Salivary Cotinine and S100A8/A9 Levels in Children Exposed to Passive Smoking
Evaluation of Periodontal Health, Salivary Cotinine and S100A8/A9 Levels in Children Exposed to Secondhand Smoking
Study Overview
Status
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Sivas, Turkey (Türkiye), 58140
- Cumhuriyet University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Systemically and genetically healthy children
Exclusion Criteria:
- Any medications known to affect defense system and periodontium
- The presence of orthodontic / intraoral appliance
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Passive smoking-exposed children
This group consists of children whose family members have smoked at home since the birth of the child.
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Passive smoking-unexposed children
This group consists of children whose family members have not smoked at home since the birth of the child.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Protein marker
Time Frame: Within 1 year
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S100A8/A9 (pg/mL)
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Within 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Passive smoking measurement
Time Frame: Within 1 year
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Cotinine (ng/mL)
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Within 1 year
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Arzu Koçkanat, Asst.Prof., Cumhuriyet University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
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
Other Study ID Numbers
- CumhuriyetU_ArzuKockanat_002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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