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临床试验/NCT02498561
NCT02498561已完成1 期

Phase 1 Study of Periodontal Disease and Obese Individuals That Investigate of Local and Systemic Antioxidant Levels of Before and After Periodontal Treatment

Figen ÖNGÖZ DEDE0 个研究点目标入组 60 人开始时间: 2013年3月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
60
主要终点
Biochemical parameters (GSH and GSSG levels, GSH/GSSG ratio )

研究概览

简要总结

Obesity may affect periodontal health by inducing gingival oxidative damage through increased production in circulating reactive oxygen species (ROS). Previous studies have reported decreased glutathione levels in patients with periodontitis when compared to healthy subjects in gingival crevicular fluid (GCF), plasma and saliva. In the present study we hypothesized that high ROS levels in circulation may decrease glutathione levels in the GCF,plasma and saliva in obese patients with chronic periodontitis, whereas periodontal therapy could have positive effects on glutathione levels.

详细描述

The purpose of this study was to investigate the effects of obesity on glutathione levels in the plasma, GCF and saliva of patients with chronic periodontitis and to evaluate changes after nonsurgical periodontal therapy.

Diagnosed as obese (n=30) and normal-weight (n=30) individuals were categorized; chronic periodontitis (CP) and periodontally healthy controls (PH). Gingival crevicular fluid (GCF), plasma, saliva samples and clinical measurements were obtained at baseline and a month after nonsurgical periodontal therapy.

Unstimulated salivary samples were collected using standard techniques. About 2 mL whole saliva was collected in disposable tubes and centrifuged immediately to remove cell debris (10,000 g x 10 minutes). The supernatants (50µL each) were stored at -40C until analyzed. GCF samples were collected from a mesio-buccal and disto-palatal site on each tooth. In the CP group, the samples were obtained from patients at areas with ≥5 mm CAL, ≥6 mm PD and ≥30% bone loss. In gingivitis group, GCF samples were obtained from teeth with BOP and without CAL. In the healthy group, GCF samples were collected from teeth exhibiting PD<3 mm without CAL and BOP. The area was isolated with cotton rolls, saliva contamination elimination was ensured, and it was slightly air dried. GCF was sampled with paper strips. Paper strips were placed into the crevice until mild resistance was felt (intracrevicular method) and left in the position for 30 seconds. Strips contaminated with blood or saliva were discarded. Each sampled strip was placed into a 400µl eppendorf centrifuge tube and stored at -40C until analyzed.

Five milliliters of venous blood was taken from antecubital vein by using a standard venipuncture method. Obtained blood sample was collected in vacutainer tubes and anti-coagulated with EDTA. The blood samples were then stored at -40C until required for use in ELISAs.

Power analysis indicated that 12 individuals for each group would be sufficient to achieve 80% power to detect a difference of 0.05 between the alternative and the null hypotheses.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
25 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • never-smokers
  • no history of systemic disease
  • no patients had been under periodontal therapy and medicine for at least 6 months before the study
  • no pregnancy or lactation
  • no alcohol or antioxidant vitamin consumption.

排除标准

  • 未提供

研究组 & 干预措施

obese-periodontally healthy controls

Placebo Comparator

GCF, plasma and GCF samples were taken at baseline after oral hygiene instructions

干预措施: oral hygiene instructions (Procedure)

normal weight-CP patients

Active Comparator

GCF, plasma and GCF samples were taken before and after nonsurgical periodontal therapy

干预措施: nonsurgical periodontal therapy (Procedure)

normal weight-PH controls

Placebo Comparator

GCF, plasma and GCF samples were taken at baseline after oral hygiene instructions

干预措施: oral hygiene instructions (Procedure)

obese-chronic periodontitis patients

Active Comparator

GCF, plasma and GCF samples were taken before and after nonsurgical periodontal therapy

干预措施: nonsurgical periodontal therapy (Procedure)

结局指标

主要结局

Biochemical parameters (GSH and GSSG levels, GSH/GSSG ratio )

时间窗: Baseline and 1 month after treatment

The changes in levels of reduced and oxidized glutathione (GSH and GSSG) 1 month after periodontal treatment determined by ELISA. The changes in levels of GSH were analyzed to determine diagnostic and prognostic potential as a biomarker of periodontitis and obesity.

次要结局

  • Probing pocket depth(Baseline and 1 month after treatment)
  • Probing pocket depth and clinical attachment level(Baseline and 1 month after treatment)
  • Gingival index(Baseline and 1 month after treatment)
  • Plaque index(Baseline and 1 month after treatment)
  • Bleeding on probing(Baseline and 1 month after treatment)

研究者

发起方
Figen ÖNGÖZ DEDE
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Figen ÖNGÖZ DEDE

Faculty of Dentistry

Bulent Ecevit University

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