NCT03639376

Brief Summary

This study investigates the salivary LL-37 in passive smoking-exposed and unexposed children and the association between salivary LL-37 levels and periodontal clinical parameters in these children.Unstimulated salivary samples were collected from 180 children (90 passive smoking-exposed and 90 passive smoking-unexposed)

Trial Health

100
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2016

Status
completed

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

Study Start

First participant enrolled

November 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 21, 2018

Completed
Last Updated

August 21, 2018

Status Verified

August 1, 2018

Enrollment Period

1.4 years

First QC Date

August 16, 2018

Last Update Submit

August 20, 2018

Conditions

Innate ImmunityPeriodontal Health

Keywords

ChildrenCotinineLL-37Passive smokingPeriodontal healthSaliva

Outcome Measures

Primary Outcomes (1)

  • Antimicrobial Peptide

    LL-37 (pg/mL)

    In the first 18 months of study

Secondary Outcomes (1)

  • Passive smoking measurement

    In the first 18 months of study

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 Kirikkale University, Faculty of Dentistry, and Department of Pediatric Dentistry

You may qualify if:

  • Systemically 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 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

August 16, 2018

First Posted

August 21, 2018

Study Start

November 1, 2016

Primary Completion

April 1, 2018

Study Completion

June 1, 2018

Last Updated

August 21, 2018

Record last verified: 2018-08