跳至主要内容
临床试验/NCT05005923
NCT05005923已完成不适用

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

Marmara University1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2019年1月23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
65
试验地点
1
主要终点
Salivary M-CSF (pg/ml) level

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
23 Years 至 51 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Salivary M-CSF (pg/ml) level

时间窗: 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

Salivary IL-34 (pg/ml) level

时间窗: 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

Salivary MIP-1α (pg/ml) level

时间窗: 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

Salivary MMP-8 (ng/ml) level

时间窗: 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

Salivary MAF (ng/ml) level

时间窗: baseline to 1 month and 3 months after treatment

change in salivary MAF levels from baseline to 1 month and 3 months after treatment

次要结局

  • Serum MMP-8 (ng/ml) level(baseline to 1 month and 3 months after treatment)
  • Serum M-CSF (pg/ml) level(baseline to 1 month and 3 months after treatment)
  • Serum MIP-1α (pg/ml) level(baseline to 1 month and 3 months after treatment)
  • Serum MAF /ng/ml) level(baseline to 1 month and 3 months after treatment)
  • Serum IL-34 (pg/ml) level(baseline to 1 month and 3 months after treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验