跳至主要内容
临床试验/NCT04642716
NCT04642716已完成不适用

Evaluation of Free Aminoacids in Saliva as A Diagnostic Biomarker of Periodontal Disease

Istanbul Medipol University Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年4月20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
60
试验地点
2
主要终点
Pocket probing depth

研究概览

简要总结

Amino acids (AAs) are organic molecules that are associated with inflammation and innate immunity diseases with critical roles in the cell repair and protection process. Our aim was to identify the free amino acids in saliva of a group of periodontitis patients and healthy individuals and additionally to assess their levels in different periodontal disease types and compare it to the healthy individuals.

详细描述

The study consisted of three groups: healthy individuals (control(C); n=20), Stage III Grade B generalized periodontitis (GP-B; n=20), and Stage III Grade C generalized periodontitis (GP-C; n=20). Clinical periodontal parameters (plaque index (PI), gingival index (GI), probing depth (PPD), gingival recession (GR), clinical attachment level (CAL) and bleeding on probing (BOP)) were measured. The amino acid analysis in saliva was accomplished by liquid chromatography-mass spectrometry (LC MS/MS) as mean concentration.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

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); diabetes diagnosis; rheumatoid arthritis diagnosis; and pregnancy, lactating, smoking, or excessive alcohol consumption.

结局指标

主要结局

Pocket probing depth

时间窗: 2 years

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: 2 years

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: 2 years

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

  • Amino acid Analysis(2 years)

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

Dr. Nur Balci

Istanbul Medipol University Hospital

研究点 (2)

Loading locations...

相似试验