Smoking, Healthy VolenteersNCT02014857
Evaluation of GCF MMP-1, -8 and Growth Factor Levels in Smokers With Periodontal Health
An observational study of Smoking, Healthy Volenteers, run by Ege University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 27 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Healthy Volenteers
- What is being tested?
- Gingival Crevicular Fluid Sampling
- Type of treatment
- Surgery or procedure
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2012to Sep 2013
- 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 19 to 27 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Dental faculty students
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University School of Dentistry Department of Periodontology
Izmir, 35100
About this study
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.
Read the detailed description
The main objective of the present study was to investigate the GCF levels of MMP-1, MMP-8, TGF-β1, PDGF-AB and VEGF in smoker versus non-smoker periodontally healthy young adults.
A total of 32 periodontally healthy young adults including 16 smokers and 16 non-smokers, were recruited for the present cross-sectional study ( 18 female and 14 males; age range: 19 to 27 years).
All participants had a thorough full-mouth clinical examination. The measurement of probing depth (PD) and clinical attachment level (CAL) were assessed at six sites per tooth in the whole mouth, excluding third molars in all study participants. Bleeding on probing (BOP) and the amount of plaque accumulation were also evaluated.
GCF sampling sites were selected from the sites without BOP and plaque accumulation. GCF samples were obtained from buccal aspects of proximal sites in a single-rooted teeth in each individual participating in the present study. Paper strips† were carefully inserted 1 mm into the crevice for 30 seconds. Care was taken to avoid mechanical trauma. The absorbed GCF volume was estimated by a calibrated instrument. Then each strip from each patient were placed into one polypropylene tube before freezing at -40°C. The readings were converted to an actual volume (µl) reference to the standard curve. All GCF samples were stored at -40°C until the laboratory analyses.
Considering a difference of 50% in mean GCF levels of the biochemical markers and assuming standard deviations to be maximum 80% of the mean values and accepting a power of 90%, P value of 5% in smoker and non-smoker groups, minimum sample size was calculated.
Chi-square test was used to determine for differences in gender and smoking state between the study groups. Student t test was applied for comparison of age between smokers and non-smokers. Normality test was performed to evaluate the distribution of clinical periodontal parameters and levels of growth factor and MMP-1, -8. Growth factor and MMP levels were compared by Mann-Whitney U test in study groups.
- Conditions
- Smoking, Healthy Volenteers
- Being tested
- Gingival Crevicular Fluid Sampling
- Keywords
- Smoking, gingival crevicular fluid, matrix metalloproteinases, intercellular signaling peptides and proteins, healthy volunteers
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gingival Crevicular Fluid SamplingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Periodonatlly healthy smokers | Gingival crevicular fluid sampling Receives: Procedure: Gingival Crevicular Fluid Sampling | |
| Periodontally healhty non-smokers | Gingival crevicular fluid sampling Receives: Procedure: Gingival Crevicular Fluid Sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
GCF levels of MMP-1, MMP-8, TGF-β1, VEGF and PDGF-AB
Total amount and concentration of these biomarkers in GCF
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2013 (estimated)
- Study startMay 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking, Healthy VolenteersStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülnihal Eren, Research Asisstant, Ege University
- Investigators
- Gul Atilla, Professor, Study director, Ege University School of DentistryHatice Oya Turkoglu, Assoc. Professor, Study chair, Ege University School of DentistryHarika Atmaca, PhD, Study chair, Manisa Celal Bayar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02014857
- Sponsor's protocol ID
- Ege University
- Status last verified
- Dec 2013
- First submitted
- 10 Dec 2013
- Last updated
- 18 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of GCF MMP-1, -8 and Growth Factor Levels in Smokers With Periodontal Health
- ClinicalTrials.gov ID
- NCT02014857
- Acronym / sponsor ID
- Ege University
- Conditions
- Smoking, Healthy Volenteers
- Keywords
- Smoking, gingival crevicular fluid, matrix metalloproteinases, intercellular signaling peptides and proteins, healthy volunteers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 18 Dec 2013 (estimated)
- 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.
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.
Detailed description
The main objective of the present study was to investigate the GCF levels of MMP-1, MMP-8, TGF-β1, PDGF-AB and VEGF in smoker versus non-smoker periodontally healthy young adults.
A total of 32 periodontally healthy young adults including 16 smokers and 16 non-smokers, were recruited for the present cross-sectional study ( 18 female and 14 males; age range: 19 to 27 years).
All participants had a thorough full-mouth clinical examination. The measurement of probing depth (PD) and clinical attachment level (CAL) were assessed at six sites per tooth in the whole mouth, excluding third molars in all study participants. Bleeding on probing (BOP) and the amount of plaque accumulation were also evaluated.
GCF sampling sites were selected from the sites without BOP and plaque accumulation. GCF samples were obtained from buccal aspects of proximal sites in a single-rooted teeth in each individual participating in the present study. Paper strips† were carefully inserted 1 mm into the crevice for 30 seconds. Care was taken to avoid mechanical trauma. The absorbed GCF volume was estimated by a calibrated instrument. Then each strip from each patient were placed into one polypropylene tube before freezing at -40°C. The readings were converted to an actual volume (µl) reference to the standard curve. All GCF samples were stored at -40°C until the laboratory analyses.
Considering a difference of 50% in mean GCF levels of the biochemical markers and assuming standard deviations to be maximum 80% of the mean values and accepting a power of 90%, P value of 5% in smoker and non-smoker groups, minimum sample size was calculated.
Chi-square test was used to determine for differences in gender and smoking state between the study groups. Student t test was applied for comparison of age between smokers and non-smokers. Normality test was performed to evaluate the distribution of clinical periodontal parameters and levels of growth factor and MMP-1, -8. Growth factor and MMP levels were compared by Mann-Whitney U test in study groups.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periodonatlly healthy smokers | – | Procedure: Gingival Crevicular Fluid SamplingGingival crevicular fluid sampling |
| Periodontally healhty non-smokers | – | Procedure: Gingival Crevicular Fluid SamplingGingival crevicular fluid sampling |
Who may qualify
- Ages
- 19 to 27 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Dental faculty students
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Gingival Crevicular Fluid Sampling | Procedure or surgery | Periodonatlly healthy smokers, Periodontally healhty non-smokers |
Primary outcome
GCF levels of MMP-1, MMP-8, TGF-β1, VEGF and PDGF-AB
Time frame: Baseline
Total amount and concentration of these biomarkers in GCF
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 18 Dec 2013.
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.
Gul Atilla, Professor study director
Ege University School of Dentistry
Hatice Oya Turkoglu, Assoc. Professor study chair
Ege University School of Dentistry
Harika Atmaca, PhD study chair
Manisa Celal Bayar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking, Healthy Volenteers, run by Ege University at 1 site in Turkey (Türkiye).
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 4 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 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
GCF levels of MMP-1, MMP-8, TGF-β1, VEGF and PDGF-AB (time frame: Baseline). 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 18 Dec 2013.