NCT03426241

Brief Summary

This study comparatively evaluate the expressions of MMP-2 and MMP-9 in smoker vs non-smoker chronic periodontitis patients as well as periodontally healthy subjects. the hypothesis of this study was that smoking may interfere with periodontal disease by effecting MMP-2 and MMP-9 expressions.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2010

Typical duration for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2012

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2012

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 8, 2018

Completed
Last Updated

February 8, 2018

Status Verified

February 1, 2018

Enrollment Period

2.9 years

First QC Date

January 29, 2018

Last Update Submit

February 7, 2018

Conditions

Keywords

chronic periodontitissmokingmmp-2mmp-9

Outcome Measures

Primary Outcomes (1)

  • expression of gelatinases levels in gingival tissue among groups

    In chronic periodontitis group, after recording the clinical parameters, gingival tissues were harvested from the deepest periodontal pocket. Whereas in periodontally healthy group, gingival tissues were collected during crown-lengthening surgery or during an extraction of a teeth for orthodontic reasons. In both groups the samples include both sulcus/pocket epithelium and underlying connective tissues. The expression of MMP-2 and MMP-9 is measured immunohistochemically

    day 1

Secondary Outcomes (2)

  • difference in probing depths among groups

    day o

  • difference in probing depths among groups

    day 0

Study Arms (4)

smoking chronic periodontitis

Other: no intervention

non-smoking periodontitis

Other: no intervention

smoking healthy

Other: no intervention

non-smoking healthy

Other: no intervention

Interventions

this is cross-sectional study

non-smoking healthynon-smoking periodontitissmoking chronic periodontitissmoking healthy

Eligibility Criteria

Age16 Years - 62 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

A total of 80 subjects (35 females, 45 males, with an age range of 16-62 years) were included in this study from those patients seeking dental treatment at the Baskent University School of Dentistry

You may qualify if:

  • A total of 80 subjects (35 females, 45 males, with an age range of 16-62 years) were included in this study from those patients seeking dental treatment at the Baskent University School of Dentistry between February 2010 and December 2012.

You may not qualify if:

  • Patients with systemic disease;
  • pregnant and/or lactating women;
  • patients taking any medications that may influence the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

PeriodontitisSmokingChronic Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesBehaviorChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinician in periodontology department

Study Record Dates

First Submitted

January 29, 2018

First Posted

February 8, 2018

Study Start

February 10, 2010

Primary Completion

December 29, 2012

Study Completion

December 30, 2012

Last Updated

February 8, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share