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Effect of Periodontal Therapy on Biomarkers in Periodontitis

2021年8月6日 更新者:Marmara University

Effect of Non-Surgical Periodontal Therapy on Salivary and Serum Biomarkers in Stage III Grade B and C Periodontitis

The present study aimed to assess the effect of non-surgical periodontal treatment on serum and salivary MMP-8, MAF, MIP-1α, M-CSF, and IL34 levels in periodontitis stage III grade B (P-III-B) and C (P-III-C) patients. 20 periodontally healthy, 20 P-III-B and 25 P-III-C participants were enrolled. At baseline, serum and saliva samples were collected and the whole mouth clinical periodontal parameters were recorded. Periodontitis patients received non-surgical periodontal treatment. Clinical parameters were re-measured and samples were re-collected at 1 and 3 months after treatment. Serum and salivary MMP-8, MAF, MIP-1α, M-CSF, and IL34 levels were analyzed by ELISA. Data were analyzed using appropriate statistical tests.

研究概览

详细说明

Periodontal disease is an inflammatory process that can result in tooth loss and also is considered a modifying factor for systemic health. Matrix metalloproteinase (MMP)-8 is the major collagenase of periodontal tissue breakdown. Macrophage-activating factor (MAF) can activate macrophages. M-CSF is known to modulate disease and inflammation and to play an important role in bone destruction. IL-34 shares vital functions of M-CSF, and manages myeloid cell survival, differentiation, and proliferation.

This study is the first controlled clinical study that examines the levels of MIP-1α, MAF, MMP-8, M-CSF, IL-34 in saliva and serum in two different periodontitis, and evaluates the situation before and after the treatment. The first hypothesis of this study; in periodontitis group, salivary and serum MIP-1α, MAF, MMP-8, M-CSF, IL-34 levels will be high, in contrast to the periodontal healthy group. The second hypothesis of this study is that after periodontal treatment, saliva and serum MIP-1α, MAF, MMP-8, M-CSF, IL-34 levels will decrease. Based on these hypotheses, the aim of the study is; to compare the levels of MIP-1a, MAF, MMP-8, M-CSF, IL-34 in saliva and serum of healthy controls, P-III-B, and P-III-C subjects and to evaluate the effect of periodontal treatment.

A total of 65 systemically healthy patients; 20 periodontally healthy, 20 P-III-B, 25 P-III-C were included in this study. The whole mouth clinical periodontal examination included measurement of probing depth (PPD), clinical attachment level (CAL), presence of bleeding on probing (BOP), gingival index (GI), and plaque index (PI) at 6 sites per tooth, except the third molars. The presence and type of the alveolar bone loss were assessed on the digital panoramic radiograph in each participant, which was supplemented with periapical radiographs if necessary.

Periodontal status of each patient was evaluated by a single calibrated periodontists with a manual probe. The diagnosis of periodontitis or periodontally health was determined according to the 2017 World Workshop on Classification of Periodontal and Peri-Implant Diseases and Conditions. Periodontally healthy individuals (n=20) in the control group had no sites with PD >3 mm and CAL >2 mm and also no radiographic evidence of alveolar bone loss. BOP was <10% in the whole mouth. Healthy group also exhibited no history of periodontitis. The periodontitis stage III patients had a minimum three teeth apart from the first molars and incisors showing CAL ≥5 mm and PD ≥6 mm and showed no>4 teeth loss because of periodontitis. Radiographic bone loss extending from coronal to middle third or beyond. Radiographic bone loss was determined from the tooth showing the most severe bone loss as a percentage of root length. If the values of bone loss %/age were between 0.25 and 1.0, the patients were assigned to grade B (n=20). If higher than 1.0, the patients were assigned to grade C (n=25)

Treatment

The recruited periodontitis patients received conventional quadrant scaling and root planning (SRP) under local anesthesia in a total of 4 sessions in two weeks. SRP was performed by the same periodontist using ultrasonic inserts and manual periodontal curettes. Re-evaluations were performed at 1 and 3 months following the completion of the SRP. No periodontal intervention was carried out in the periodontally healthy controls.

Saliva and Serum Sampling A total of 5 mL of unstimulated whole saliva was collected by passive drool method between 9:00 and 10:00 am. The participants were advised to avoid food consumption for three hours before sample collection. The participants were seated upright and saliva was collected over a period of 5 minutes with instructions to pool saliva in the floor of the mouth and passively drool it into a sterile glass beaker. Then saliva samples are immediately transferred to a 2 mL polypropylene tube and stored at -80°C. A total of 5 mL of blood was collected from the antecubital fossa by venepuncture method. Serum was isolated from the blood by centrifuging at 5000 rpm for 10 minutes followed by its rapid transfer to a sterile polypropylene tube and storage at -80°C.

Biomarker Immunoassays Saliva and serum samples were thawed on ice. The saliva samples were centrifuged at 5.000 rpm for 15 minutes at room temperature, and supernatants were immediately used for assays. Serum and salivary samples of MMP-8 , M-CSF*, MIP-1α*, MAF , IL-34 in were measured by ELISA using commercial kits.

Statistical Analysis All statistical analyses were carried out with the standard statistical software package. For the intra-group comparisons, if the data were not normally disturbed, Friedman test and the Dunn test with the Bonferroni correction were used to analyze the change between baseline and 1 month and 3 months after treatment. For inter-group comparisons, Mann-Whitney U test for normally and non-normally disturbed data. The Spearman's rank correlation test was used to detect the correlations of biochemical parameters with clinical parameters and each others in diseased group before and after treatment. All tests were performed at significance level of P <0.05.

研究类型

介入性

注册 (实际的)

65

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Istanbul、火鸡
        • Marmara University, Faculty of Dentistry, Department of Periodontology

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

23年 至 51年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. systemically healthy and non-smoker individuals
  2. having ≥20 teeth present (except third molars)
  3. individuals with periodontally healthy, periodontitis stage III grade B and C diagnoses

Exclusion Criteria:

  1. having any diagnosed medical disorders such as diabetes mellitus, cardiovascular diseases, rheumatoid arthritis, immunological and mucocutaneous diseases
  2. usage of antibiotics, non-steroidal anti-inflammatory drugs and immunosuppressive agents within the past 6 months
  3. having any non-inflammatory destructive periodontal disease
  4. nonsurgical/surgical periodontal therapy received in the past year
  5. pregnant/ lactating/ postmenopausal females.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:非随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
无干预:Periodontal healthy
有源比较器:Periodontitis Stage III Grade B
The patients were subjected to quadrant-wise full-mouth subgingival scaling and root planning under local anesthesia. The entire non-surgical periodontal treatment of periodontitis groups was completed in a total of 4 sessions in two weeks.
使用手动和超声波仪器对牙周炎患者进行治疗。
有源比较器:Periodontitis Stage III Grade C
The patients were subjected to quadrant-wise full-mouth subgingival scaling and root planning under local anesthesia. The entire non-surgical periodontal treatment of periodontitis groups was completed in a total of 4 sessions in two weeks.
使用手动和超声波仪器对牙周炎患者进行治疗。

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Salivary MMP-8 (ng/ml) level
大体时间:baseline to 1 month and 3 months after treatment
change in salivary MMP-8 levels from baseline to 1 month and 3 months after treatment
baseline to 1 month and 3 months after treatment
Salivary MAF (ng/ml) level
大体时间:baseline to 1 month and 3 months after treatment
change in salivary MAF levels from baseline to 1 month and 3 months after treatment
baseline to 1 month and 3 months after treatment
Salivary MIP-1α (pg/ml) level
大体时间:baseline to 1 month and 3 months after treatment
change in salivary MIP-1α levels from baseline to 1 month and 3 months after treatment
baseline to 1 month and 3 months after treatment
Salivary M-CSF (pg/ml) level
大体时间:baseline to 1 month and 3 months after treatment
change in salivary M-CSF levels from baseline to 1 month and 3 months after treatment
baseline to 1 month and 3 months after treatment
Salivary IL-34 (pg/ml) level
大体时间:baseline to 1 month and 3 months after treatment
change in salivary M-CSF levels from baseline to 1 month and 3 months after treatment
baseline to 1 month and 3 months after treatment

次要结果测量

结果测量
措施说明
大体时间
血清 IL-34 (pg/ml) 水平
大体时间:基线至治疗后 1 个月和 3 个月
血清 IL-34 水平从基线到治疗后 1 个月和 3 个月的变化
基线至治疗后 1 个月和 3 个月
Serum MMP-8 (ng/ml) level
大体时间:baseline to 1 month and 3 months after treatment
change in serum MMP-8 levels from baseline to 1 month and 3 months after treatment
baseline to 1 month and 3 months after treatment
Serum MAF /ng/ml) level
大体时间:baseline to 1 month and 3 months after treatment
change in serum MAF levels from baseline to 1 month and 3 months after treatment
baseline to 1 month and 3 months after treatment
Serum MIP-1α (pg/ml) level
大体时间:baseline to 1 month and 3 months after treatment
change in serum MIP-1α levels from baseline to 1 month and 3 months after treatment
baseline to 1 month and 3 months after treatment
Serum M-CSF (pg/ml) level
大体时间:baseline to 1 month and 3 months after treatment
change in serum M-CSF levels from baseline to 1 month and 3 months after treatment
baseline to 1 month and 3 months after treatment

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年1月23日

初级完成 (实际的)

2020年7月24日

研究完成 (实际的)

2020年7月24日

研究注册日期

首次提交

2021年7月29日

首先提交符合 QC 标准的

2021年8月6日

首次发布 (实际的)

2021年8月16日

研究记录更新

最后更新发布 (实际的)

2021年8月16日

上次提交的符合 QC 标准的更新

2021年8月6日

最后验证

2021年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • SAG-A-230119-0014

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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