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临床试验/NCT02660814
NCT02660814已完成早期 1 期

Effects of Non-Surgical Periodontal Treatment on the Gingival Crevicular Fluid Levels of Chemerin in Obese Patients With Chronic Periodontitis

Umut BALLI0 个研究点目标入组 72 人开始时间: 2014年7月1日最近更新:
适应症

试验速览

阶段
早期 1 期
状态
已完成
发起方
入组人数
72
主要终点
Chemerin

研究概览

简要总结

The objective in this case-control intervention study, therefore, was to explore the effect of nonsurgical periodontal therapy on the GCF levels of chemerin and IL-6 in patients with chronic periodontitis in order to determine the usefulness of chemerin as a diagnostic and prognostic biomarker of periodontal disease.

详细描述

All individuals underwent a full-mouth periodontal examination, which included probing pocket depth (PPD), clinical attachment level (CAL), plaque index (PI), gingival index (GI), bleeding on probing (BOP). BMI and WHR were used for assessing obesity. In addition, HbA1c and fasting plasma glucose levels were used for elimination of diabetes mellitus. Based on the periodontal and anthropometric measurements, individuals (n=72) were divided into four groups: the periodontal-healthy group (n=18), chronic periodontitis group (n=18), periodontal-healthy with obesity group (n=18) and chronic periodontitis with obesity group (n=18). Periodontitis patients received nonsurgical periodontal therapy. GCF sampling and clinical periodontal parameters were assessed before and 6 weeks after therapy. Chemerin and IL-6 levels were measured by enzyme-linked immunosorbent assay.

研究设计

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

入排标准

年龄范围
32 Years 至 53 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 32-53 years of age
  • had a minimum of 20 natural teeth, excluding third molars
  • glycosylated hemoglobi levels <6%
  • fasting plasma glucose levels <100 mg/dl.
  • 5-) Criteria for the periodontal healthy group were GI = 0, PPD≤ 3 mm, and no signs of attachment and bone loss by clinical and radiographic examination.
  • 6-) Criteria for the chronic periodontitis group were clinical signs of inflammation (red color and swelling of the gingival margin), GI ≥ 2, PPD and CAL ≥ 5 mm, and bone loss affecting >30% of the existing teeth on clinical and radiographic examination.
  • 7-) Criteria for obese groups were 30≤ BMI <40 kg/m2, and concomitant WHR ≥0.85 for females and WHR ≥0.90 for males.
  • 8-) Criteria for normal-weight groups were 20≤ BMI <25 kg/m2, and WHR below that determined for obesity.

排除标准

  • Aggressive periodontitis
  • Periapical pathologies
  • Excessive forces including mechanical forces from orthodontics and occlusion
  • Systemic diseases (e.g., diabetes mellitus; cancer; human immunodeficiency virus; or disorders that could affect adipokines levels and the periodontal conditions)
  • Chronic high-dose steroid therapy, radiation or immunosuppressive therapy
  • Pregnancy, lactation
  • Smoking within the past five years, or allergy or sensitivity to any drug
  • Had no history of periodontal therapy or drug therapy (e.g., anti-inflammatories, antibiotics, or any other pharmacological treatment) for at least six months

结局指标

主要结局

Chemerin

时间窗: Baseline and 6 weeks after treatment

The changes in levels of chemerin 6 weeks after periodontal treatment determined by ELISA.

次要结局

  • Probing pocket depth(Baseline and 6 weeks after treatment)
  • Clinical attachment level(Baseline and 6 weeks after treatment)
  • Interleukin-6(Baseline and 6 weeks after treatment)
  • Gingival index(Baseline and 6 weeks after treatment)
  • Plaque index(Baseline and 6 weeks after treatment)
  • Bleeding on probing(Baseline and 6 weeks after treatment)

研究者

发起方
Umut BALLI
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Umut BALLI

Principal Investigator

Bulent Ecevit University

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