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临床试验/NCT02014857
NCT02014857已完成不适用

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

Ege University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2012年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
1
主要终点
GCF levels of MMP-1, MMP-8, TGF-β1, VEGF and PDGF-AB

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
19 Years 至 27 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

GCF levels of MMP-1, MMP-8, TGF-β1, VEGF and PDGF-AB

时间窗: Baseline

Total amount and concentration of these biomarkers in GCF

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gülnihal Eren, Research Asisstant

Research Assistant

Ege University

研究点 (1)

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