IL-32 Levels in Gingival Crevicular Fluid and Saliva of Patients With Chronic Periodontitis After Periodontal Treatment.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 主要终点
- Biochemical parameters (IL-32, IL-10 and THF-alpha)
研究概览
简要总结
Interleukin-32 (IL-32) is a recently described cytokine that is a strong inducer of pro-inflammatory cytokines such as tumor necrosis factor (TNF)-α. A previous report have reported that Porphyromonas gingivalis-derived LPS significantly up-regulated IL-32 expression compared with the unstimulated cells in monocytes (THP-1 cells). They suggested that IL-32 may contribute to the pathogenesis of periodontal disease. In the present study the investigators hypothesized that IL-32 levels may increase in the gingival crevicular fluid (GCF) and saliva of patients with chronic periodontitis compared with healthy controls and these levels may decrease together with treatment.
详细描述
The purpose of this study was to investigate IL-32 levels in the GCF and saliva of patients with chronic periodontitis and to evaluate changes after nonsurgical periodontal therapy.
Twenty-seven CP and 27 periodontally healthy controls were enrolled in this study. Periodontitis patients received nonsurgical periodontal treatment. GCF and saliva sampling and clinical periodontal parameters were assessed before and a month after treatment. IL-32, IL-10 and TNF-α levels in GCF and saliva were measured by enzyme-linked immunosorbent assay.
Unstimulated salivary samples were collected using standard techniques. About 2 mL whole saliva was collected in disposable tubes and centrifuged immediately to remove cell debris (10,000 g x 10 minutes). The supernatants (50µL each) were stored at -40C until analyzed. GCF samples were collected from a mesio-buccal and disto-palatal site on each tooth. In the CP group, the samples were obtained from patients at areas with ≥5 mm CAL, ≥6 mm PD and ≥30% bone loss. In the healthy group, GCF samples were collected from teeth exhibiting PD<3 mm without CAL and BOP. The area was isolated with cotton rolls, saliva contamination elimination was ensured, and it was slightly air dried. GCF was sampled with paper strips. Paper strips were placed into the crevice until mild resistance was felt (intracrevicular method) and left in the position for 30 seconds. Strips contaminated with blood or saliva were discarded. Each sampled strip was placed into a 400µl eppendorf centrifuge tube and stored at -40C until analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •all subjects in the study were possess of at least 20 teeth excluding third molars.
排除标准
- •agressive periodontitis,
- •periapical pathologies,
- •excessive forces including mechanical forces caused by orthodontic forces and occlusal forces;
- •presence of systemic diseases;
- •administration of non-steroidal and anti-inflammatory drugs or antibiotic therapies within the previous 6 months;
- •need for antibiotic prophylaxis for dental treatment and having received non-surgical periodontal treatment within the past 6 months or surgical periodontal treatment within the past 12 months;
- •allergy or sensitivity to any drug,
- •pregnancy,
- •lactation, and
- •current and former use of tobacco.
结局指标
主要结局
Biochemical parameters (IL-32, IL-10 and THF-alpha)
时间窗: Baseline and 1 month after treatment
The changes in levels of IL-32 after periodontal treatment determined by ELISA. The changes in levels of IL-32 were analyzed to determine diagnostic and prognostic potential as a biomarker of periodontitis.
次要结局
- Probing pocket depth(Baseline and 1 month after treatment)
- Probing pocket depth and clinical attachment level(Baseline and 1 month after treatment)
- Gingival index(Baseline and 1 month after treatment)
- Plaque index(Baseline and 1 month after treatment)
- Bleeding on probing(Baseline and 1 month after treatment)
研究者
Figen ÖNGÖZ DEDE
Bülent Ecevit University Faculty of Dentistry
Bulent Ecevit University