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临床试验/NCT05448976
NCT05448976已完成不适用

Potential Effect for the Smoking on Periodontitis From the Perspective of Arginine Metabolites Symmetric Dimethylarginine (SDMA) and Asymmetric Dimethylarginine (ADMA)

Istanbul Medipol University Hospital2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年8月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
2
主要终点
Pocket probing depth

研究概览

简要总结

Arginine metabolites are amino acids that are associated with vascular tone regulation and the level of inflammation, with critical roles in the synthesis of NO. Our aim was to determine the ADMA, SDMA, L-NMMA, L-arginine, L-homoarginine and IL-6 levels in saliva and serum samples from periodontitis patients and periodontally healthy individuals and to assess the levels of these compounds according to smoking status and compare these levels to those of healthy individuals.

详细描述

The study consisted of four groups: healthy individuals (control (C); n=20), smokers with healthy periodontium (S-C; n=20), nonsmokers with Stage III Grade B generalized periodontitis (P; n=20) and smokers with Stage III Grade C generalized periodontitis (S-P; n=18). Clinical periodontal parameters were measured. The determination of methylated arginine metabolites was carried out by LC-MS/MS.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • systemically healthy
  • clinical diagnosis of periodontitis
  • clinical diagnosis of periodontal health
  • For smoking group the so kerr were denied as smoking at least 10 cigarettes per day and the duration should more than 10 years.

排除标准

  • history of regular use of systemic antibiotics anti-inflammatory, or antioxidant drugs (previous 3 months)
  • nonsurgical periodontal treatment (previous 6 months)
  • surgical periodontal treatment (previous 12 months)
  • presence of<10 teeth
  • current medications affecting gingival health (calcium channel blockers, phenytoin, cyclosporine, and hormone replacement therapy)
  • diagnosis of rheumatoid arthritis
  • pregnancy
  • lactating
  • excessive alcohol consumption.

结局指标

主要结局

Pocket probing depth

时间窗: 6 months

Measurement of the depth of a sulcus or periodontal pocket determined by measuring distance from a gingival margin to the base of the sulcus or pocket with a calibrated periodontal probe

Clinical attachment level

时间窗: 9 months

Clinical attachment level (or loss, CAL) is a more accurate indicator of the periodontal support around a tooth than probing depth alone. CAL is measured from a fixed point on the tooth that does not change, the CEJ. To calculate CAL, two measurements are needed: distance from the gingival margin to the CEJ and probing depth. In recession: probing depth (+) gingival margin to the CEJ (add). In tissue overgrowth: probing depth (-) gingival margin to the CEJ (subtract)

Bleeding on probing

时间窗: 9 months

referring to bleeding that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus, or interface between the gingiva and a tooth

次要结局

  • Saliva and serum samples processing(2 months)
  • serum and saliva analyses for arginine metabolites(2 months)

研究者

发起方
Istanbul Medipol University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nur Balci, DDs, PhD

ASSOC. PROF DR

Istanbul Medipol University Hospital

研究点 (2)

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