NCT02014857

Brief Summary

Increased levels of cytokines in GCF have been demonstrated in smoker subjects with chronic periodontitis. It is not surprising that increased levels of inflammation associated molecules in GCF has been observed in smokers with periodontitis. However, it is not clear if smoking has an influence on these parameters in periodontally healthy individuals. In the present study, it has been hypothesized that smoking might affect the levels of GCF MMPs and growth factors in young adults with periodontal health.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2012

Geographic Reach
1 country

1 active site

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

May 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 18, 2013

Completed
Last Updated

December 18, 2013

Status Verified

December 1, 2013

Enrollment Period

1.3 years

First QC Date

December 10, 2013

Last Update Submit

December 12, 2013

Conditions

Keywords

Smoking, gingival crevicular fluid, matrix metalloproteinases, intercellular signaling peptides and proteins, healthy volunteers

Outcome Measures

Primary Outcomes (1)

  • GCF levels of MMP-1, MMP-8, TGF-β1, VEGF and PDGF-AB

    Total amount and concentration of these biomarkers in GCF

    Baseline

Study Arms (2)

Periodonatlly healthy smokers

Gingival crevicular fluid sampling

Procedure: Gingival Crevicular Fluid Sampling

Periodontally healhty non-smokers

Gingival crevicular fluid sampling

Procedure: Gingival Crevicular Fluid Sampling

Interventions

Periodonatlly healthy smokersPeriodontally healhty non-smokers

Eligibility Criteria

Age19 Years - 27 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Dental faculty students

You may qualify if:

  • Periodontally and systemically healthy individuals
  • Have at least 20 teeth
  • \>10 cigarettes/day consumption for smoker group
  • Non-smokers subjects were selected from periodontally healthy participants who had never smoked.

You may not qualify if:

  • Any health condition affecting their systemic status such as diabetes mellitus, immunologic disorders, human immunodeficiency virus infections, hepatitis were excluded
  • Also pregnant and lactating women and those taking oral contraceptive drugs were not included in the study.
  • Any antibiotic intake within the last 3 months and any periodontal treatment within 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University School of Dentistry Department of Periodontology

Izmir, 35100, Turkey (Türkiye)

Location

Biospecimen

Retention: NONE RETAINED

Gingival crevicular fluid

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Gul Atilla, Professor

    Ege University School of Dentistry

    STUDY DIRECTOR
  • Hatice Oya Turkoglu, Assoc. Professor

    Ege University School of Dentistry

    STUDY CHAIR
  • Harika Atmaca, PhD

    Celal Bayar University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

December 10, 2013

First Posted

December 18, 2013

Study Start

May 1, 2012

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

December 18, 2013

Record last verified: 2013-12

Locations