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Completed

NCT Number: NCT02014857

Evaluation of GCF MMP-1, -8 and Growth Factor Levels in Smokers With Periodontal Health

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.

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Key information

Age range

19 year–27 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ege University School of Dentistry Department of Periodontology

Izmir, 35100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gingival Crevicular Fluid Sampling

Procedure

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 18, 2013
Registry last updated
Dec 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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