Assesment of Gingival Crevicular Fluid and Serum ErbB4/Neuregulin-4 Levels in Periodontal Disease and Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Biochemical parameters (IL-6, IL-10, nitric oxide synthase (NOS) 2 and Arg1)
研究概览
简要总结
This study aimed to investigate gingival crevicular fluid (GCF) and serum ErbB4 and Nrg4 levels in periodontal health and disease. A total of 80 individuals, 20 patients with stage II grade B periodontitis, 20 patients with stage III grade B 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 and serum ErbB4 and Nrg4 levels were measured by enzyme-linked immunosorbent assay. Statistical analysis was performed by using non-parametric tests.
详细描述
A total of 80 individuals, comprising 20 patients with stage II grade B periodontitis (P1 Group), 20 patients with stage III grade B periodontitis (P2 Group), 20 patients with gingivitis (G Group), and 20 periodontally healthy controls (H Group) were involved in the study.
The participants were classified into four groups depending on periodontal health status in accordance with the consensus reports of the 2017 World Workshop:
- periodontally healthy (H) group: no interproximal attachment loss (AL), probing depth (PD) ≤3 mm, bleeding on probing (BOP) scores <10%;
- gingivitis (G) group: no interproximal AL, PD ≤3 mm, and BOP ≥10%;
- stage II grade B periodontitis (P1) group: 3 <PD ≤5 mm and 3 ≤ clinical attachment loss (CAL) <5 mm in one or more sites of the 2 non-adjacent teeth in at least two quadrants of the mouth, full mouth BOP ≥ 10% and no tooth loss due to periodontitis
- stage III grade B periodontitis (P2) group: PD >5 mm and CAL ≥ 5 mm in one or more sites of the 2 non-adjacent teeth in at least two quadrants of the mouth, full mouth BOP >10% and tooth loss due to periodontitis of ≤4 teeth.
Inclusion criteria were as follows:
- aged >18 years,
- having at least 16 natural teeth (excluding third molar),
- not having any diagnosed medical illness or drug intake that could affect the periodontal condition.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged >18 years,
- •Having at least 16 natural teeth (excluding third molar),
- •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,
- •Heavy smoking and having serum CRP > 3mg/L .
研究组 & 干预措施
stage II grade B periodontitis
GCF and serum samples were taken before and after treatment from stage II grade B periodontitis patients.
Intervention: Non- surgical periodontal treatment (SRP and oral hygiene instructions)
干预措施: non surgical periodontal treatment (Other)
stage II grade B periodontitis
GCF and serum samples were taken before and after treatment from stage II grade B periodontitis patients.
Intervention: Non- surgical periodontal treatment (SRP and oral hygiene instructions)
干预措施: Gingival crevicular fluid and serum collection (Other)
stage III grade B periodontitis
GCF and serum samples were taken before and after treatment from stage III grade B periodontitis patients.
Intervention: Non- surgical periodontal treatment (SRP and oral hygiene instructions)
干预措施: non surgical periodontal treatment (Other)
stage III grade B periodontitis
GCF and serum samples were taken before and after treatment from stage III grade B periodontitis patients.
Intervention: Non- surgical periodontal treatment (SRP and oral hygiene instructions)
干预措施: Gingival crevicular fluid and serum collection (Other)
gingivitis
GCF and serum samples were taken before and after treatment from gingivitis patients.
Intervention: Non- surgical periodontal treatment (Scaling and oral hygiene instructions)
干预措施: non surgical periodontal treatment (Other)
gingivitis
GCF and serum samples were taken before and after treatment from gingivitis patients.
Intervention: Non- surgical periodontal treatment (Scaling and oral hygiene instructions)
干预措施: Gingival crevicular fluid and serum collection (Other)
periodontally healthy
GCF and serum samples were taken at baseline from periodontally healthy individuals.
干预措施: Gingival crevicular fluid and serum collection (Other)
结局指标
主要结局
Biochemical parameters (IL-6, IL-10, nitric oxide synthase (NOS) 2 and Arg1)
时间窗: Baseline and 4 weeks after treatment
The changes in GCF levels of IL-6 and IL-10 and serum levels of nitric oxide synthase (NOS)2 and Arg1, four weeks after periodontal treatment determined by ELISA.
Biochemical parameters (ErbB4 and Nrg4)
时间窗: Baseline and 4 weeks after treatment
The changes in levels of ErbB4 and Nrg4, four weeks after periodontal treatment determined by ELISA. The changes in levels of ErbB4 and Nrg4 were analyzed to determine as a diagnostic biomarker of periodontal disease.
次要结局
- 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)
- Clinical attachment loss(Baseline and 4 weeks after treatment)
- Papillar bleeding index(Baseline and 4 weeks after treatment)
- Bleeding on probing(Baseline and 4 weeks after treatment)
研究者
Sadiye Gunpinar
Asst. Prof.
Abant Izzet Baysal University