- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02014857
Evaluation of GCF MMP-1, -8 and Growth Factor Levels in Smokers With Periodontal Health
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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İzmir, Turkey, 35100
- Ege University School of Dentistry Department of Periodontology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Periodonatlly healthy smokers
Gingival crevicular fluid sampling
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Periodontally healhty non-smokers
Gingival crevicular fluid sampling
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Hatice Oya Turkoglu, Assoc. Professor, Ege University School of Dentistry
- Study Chair: Harika Atmaca, PhD, Celal Bayar University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Ege University
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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