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临床试验/NCT03919006
NCT03919006已完成不适用

Levels of Netrin 1 and Its Receptor Unc5b in Gingival Crevicular Fluid, Saliva and Serum in Periodontal Disease and Health

Abant Izzet Baysal University2 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Biochemical parameters (Netrin-1 and Unc5b)

研究概览

简要总结

This study aimed to investigate gingival crevicular fluid (GCF), saliva and serum Netrin 1 and Unc5b levels in periodontal health and disease. A total of 60 individuals, 20 patients with periodontitis, 20 with gingivitis and 20 periodontally healthy individuals were included. Whole-mouth and site-specific clinical periodontal parameters including probing depth, clinical attachment level, bleeding on probing, gingival index, plaque index and papillar bleeding index were recorded. GCF, salivary and serum Netrin 1 and Unc5b levels were measured by enzyme-linked immunosorbent assay. Statistical analysis was performed by using non-parametric tests.

详细描述

A total of 60 individuals, comprising 20 patients with Periodontitis (P Group), 20 patients with gingivitis (G Group), and 20 periodontally healthy controls (H Group) were involved in the study. The patients were diagnosed according to the new classification scheme. Stage and extent of periodontitis were also determined.

The clinical periodontal criteria for the diagnosis of the groups were as follows: the periodontitis group had interdental clinical attachment loss (CAL) ≥5 mm at site of greatest loss and periodontal probing depth (PD) ≥ 6 mm in one or more sites of the 2 non-adjacent teeth in at least two quadrants of the mouth. Accordingly, Stage III generalized periodontitis patients were included in the study. Patients were diagnosed as gingivitis with bleeding on probing ≥ 50 %, PD ≤3 mm, and no radiographic bone loss or CAL. Periodontally healthy individuals had no recorded history of periodontal problems, with PD ≤3 mm, no radiographic bone loss, good oral hygiene, no gingival inflammation.

Inclusion criteria were as follows: (1) aged >18 years, (2) having at least 16 natural teeth (excluding third molar),(3) nonsmokers with no history of smoking, (4) not having any diagnosed medical illness or drug intake that could affect the periodontal condition. The patients who had (1) taken antibiotics, nonsteroidal antiinflammatory or any other drugs within the past 3 months,(2) received nonsurgical or surgical periodontal treatment, (3) a restorative and endodontic therapy requirement, (4) a removable partial denture and/or having orthodontic therapy were excluded from the study. Current pregnancy or lactation and having serum C reactive protein (CRP) > 3mg/L were also the exclusion criteria.

All individuals were examined at baseline and four weeks after non-surgical periodontal treatment including, whole mouth probing depth (PD), CAL, presence of bleeding on probing (BOP), papillar bleeding index (PBI), gingival index (GI) and plaque index (PI) except the third molars. PD and CAL were measured at six sites per tooth using a manual periodontal probe.

The non-surgical periodontal treatment for periodontitis group included supra- and subgingival scaling, root planing and oral hygiene instructions. Subgingival scaling and root planing were performed under local anesthesia in two sessions within the 48-72 h. Gingivitis group had supra-and subgingival scaling, polishing and oral hygiene instructions. The treatment of gingivitis and periodontitis patients were performed by a periodontist (BM) using hand and ultrasonic instruments. All measurements were performed by the same calibrated examiner (SG).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

盲法说明

Single (Outcomes Assessor)

入排标准

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

入选标准

  • Aged >18 years,
  • Having at least 16 natural teeth (excluding third molar),
  • Nonsmokers with no history of smoking,
  • Not having any diagnosed medical illness or drug intake that could affect the periodontal condition.

排除标准

  • Patients who had taken antibiotics, nonsteroidal antiinflammatory or any other drugs within the past 3 months,
  • Patients received nonsurgical or surgical periodontal treatment,
  • Patients who have a restorative and endodontic therapy requirement,
  • Having a removable partial denture and/or having orthodontic therapy,
  • Current pregnancy or lactation and having serum CRP > 3mg/L .

结局指标

主要结局

Biochemical parameters (Netrin-1 and Unc5b)

时间窗: Baseline and 4 weeks after treatment

The changes in levels of Netrin-1 and Unc5b 4 weeks after periodontal treatment determined by ELISA. The changes in levels of Netrin-1 and Unc5b were analyzed to determine as a diagnostic biomarker of periodontal disease.

次要结局

  • Clinical attachment loss(Baseline and 4 weeks after treatment)
  • Bleeding on probing(Baseline and 4 weeks after treatment)
  • Papillar bleeding index(Baseline and 4 weeks after treatment)
  • Probing pocket depth(Baseline and 4 weeks after treatment)
  • Gingival index(Baseline and 4 weeks after treatment)
  • Plaque index(Baseline and 4 weeks after treatment)

研究者

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

Sadiye Gunpinar

Asst. Prof.

Abant Izzet Baysal University

研究点 (2)

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