NCT06791707

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
146

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 24, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

February 24, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 19, 2025

Completed
Last Updated

November 25, 2025

Status Verified

January 1, 2025

Enrollment Period

7 months

First QC Date

January 20, 2025

Last Update Submit

November 22, 2025

Conditions

Secondhand Smoke ExposureChildrenInflamationCotinine Levels

Outcome Measures

Primary Outcomes (1)

  • Protein marker

    S100A8/A9 (pg/mL)

    Within 1 year

Secondary Outcomes (1)

  • Passive smoking measurement

    Within 1 year

Study Arms (2)

Passive smoking-exposed children

This group consists of children whose family members have smoked at home since the birth of the child.

Passive smoking-unexposed children

This group consists of children whose family members have not smoked at home since the birth of the child.

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Systemically and genetically healthy children

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cumhuriyet University

Sivas, 58140, Turkey (Türkiye)

Location

Study Officials

  • Arzu Koçkanat, Asst.Prof.

    Cumhuriyet University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 20, 2025

First Posted

January 24, 2025

Study Start

February 24, 2025

Primary Completion

September 19, 2025

Study Completion

November 19, 2025

Last Updated

November 25, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)