PeriodontitisNCT03426241
Effect of Smoking on the Expression of Gelatinases in Chronic Periodontitis
An observational study of Periodontitis and Smoking, run by Baskent University.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 62 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Smoking
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 10 Feb 2010to 30 Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 62 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
- 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.
Who cannot join
- Patients with systemic disease;
- pregnant and/or lactating women;
- patients taking any medications that may influence the study.
About this study
Official title: The Effect of Smoking on the Expression of Gelatinases in Chronic Periodontitis: A Cross-sectional Study
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.
Read the detailed description
Smokers have greater risk for developing periodontal disease and smoking is highly correlated with greater marginal bone loss. Matrix metalloproteinases (MMP) play a major role in periodontal tissue destruction. MMP-2 and MMP-9, called gelatinases, are one of the major MMPs that plays important roles in periodontitis. To date, several studies showed the increased levels of gelatinases in periodontal disease and only a limited number of study investigated the effect of smoking on gelatinases. However, no previous study has directly investigated the possible relationship between smoking and gingival tissue gelatinases expressions (MMP-2 and MMP-9) in chronic periodontitis (CP) patients relative to periodontally healthy subjects.
Therefore this study is conducted to 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 of this study hypothesis was that smoking may interfere with periodontal disease by effecting MMP-2 and MMP-9 expressions.
- Conditions
- Periodontitis, Smoking
- Being tested
- no intervention
- Keywords
- chronic periodontitis, smoking, mmp-2, mmp-9
- Medical subject headings
- Periodontitis, Smoking, Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
this is cross-sectional study
| Study group | Role | What they receive |
|---|---|---|
| smoking chronic periodontitis | Not described Receives: Other: no intervention | |
| non-smoking periodontitis | Not described Receives: Other: no intervention | |
| smoking healthy | Not described Receives: Other: no intervention | |
| non-smoking healthy | Not described Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: day 1
Secondary outcomes (2)
difference in probing depths among groups
Clinical parameters will be recorded and difference in probing depths among the groups will be calculated
Measured: day o
difference in probing depths among groups
Clinical parameters will be recorded and difference in clinical attahment level among the groups will be calculated
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start10 Feb 2010
- Primary completion29 Dec 2012
- Study completion30 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Sezgin, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03426241
- Sponsor's protocol ID
- BaskentU2
- Status last verified
- Feb 2018
- First submitted
- 29 Jan 2018
- Last updated
- 8 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Smoking on the Expression of Gelatinases in Chronic Periodontitis: A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT03426241
- Acronym / sponsor ID
- BaskentU2
- Conditions
- Periodontitis, Smoking
- Keywords
- chronic periodontitis, smoking, mmp-2, mmp-9
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 10 Feb 2010 (actual)
- Primary completion
- 29 Dec 2012 (actual)
- Study completion
- 30 Dec 2012 (actual)
- First posted
- 8 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Smokers have greater risk for developing periodontal disease and smoking is highly correlated with greater marginal bone loss. Matrix metalloproteinases (MMP) play a major role in periodontal tissue destruction. MMP-2 and MMP-9, called gelatinases, are one of the major MMPs that plays important roles in periodontitis. To date, several studies showed the increased levels of gelatinases in periodontal disease and only a limited number of study investigated the effect of smoking on gelatinases. However, no previous study has directly investigated the possible relationship between smoking and gingival tissue gelatinases expressions (MMP-2 and MMP-9) in chronic periodontitis (CP) patients relative to periodontally healthy subjects.
Therefore this study is conducted to 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 of this study hypothesis was that smoking may interfere with periodontal disease by effecting MMP-2 and MMP-9 expressions.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| smoking chronic periodontitis | – | Other: no intervention |
| non-smoking periodontitis | – | Other: no intervention |
| smoking healthy | – | Other: no intervention |
| non-smoking healthy | – | Other: no intervention |
Who may qualify
- Ages
- 16 to 62 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients with systemic disease;
- pregnant and/or lactating women;
- patients taking any medications that may influence the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionthis is cross-sectional study | Other | non-smoking healthy, non-smoking periodontitis, smoking chronic periodontitis, smoking healthy |
Primary outcome
expression of gelatinases levels in gingival tissue among groups
Time frame: day 1
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
2 secondary outcomes
difference in probing depths among groups
Time frame: day o
difference in probing depths among groups
Time frame: day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis and Smoking, run by Baskent University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
expression of gelatinases levels in gingival tissue among groups (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2018.