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临床试验/NCT05262153
NCT05262153已完成不适用

Clinical and Biochemical Effect of Smoking on Non-surgical Periodontal Treatment in Periodontitis Grade III Stage C Patients

Marmara University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年1月25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
1
主要终点
Salivary OPG (pg/ml) level

研究概览

简要总结

The present study aimed to assess the effect of smoking on non-surgical periodontal treatment on serum and salivary RANKL, OPG and IL34 levels in periodontitis stage III grade C (P-III-C) patients. 20 periodontally healthy, 20 P-III-C and 20 P-III-C with smoking (P-III-CS) 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 RANKL, OPG 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. In bone tissue, bone resorption by osteoclasts and bone formation by osteoblasts are repeated continuously. Osteoclasts are multinucleated cells that derive from monocyte-/macrophage-lineage cells and resorb bone. In contrast, osteoblasts mediate osteoclastogenesis by expressing receptor activator of nuclear factor-kappa B ligand (RANKL), which is expressed as a membrane-associated cytokine. Osteoprotegerin (OPG) is a soluble RANKL decoy receptor that is predominantly produced by osteoblasts and which prevents osteoclast formation and osteoclastic bone resorption by inhibiting the RANKL-RANKL receptor interaction. 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 RANKL, OPG and IL-34 in saliva and serum in smoker and non-smoker periodontitis, and evaluates the situation before and after the treatment. The first hypothesis of this study; in smoker periodontitis group, salivary and serum RANKL, OPG and IL-34 levels will be high, in contrast to the non-smoker periodontitis and periodontal healthy group. The second hypothesis of this study is that after periodontal treatment, saliva and serum RANKL and IL-34 levels will decrease, saliva and serum OPG will increase. Based on these hypotheses, the aim of the study is; to compare the levels of RANKL, OPG and IL-34 in saliva and serum of healthy controls, P-III-C, and P-III-CS subjects and to evaluate the effect of periodontal treatment.

A total of 60 systemically healthy patients; 20 periodontally healthy, 20 P-III-C, 20 P-III-CS 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.

Treatment

研究设计

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

入排标准

年龄范围
24 Years 至 56 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • systemically healthy individuals
  • having ≥20 teeth present (except third molars)
  • individuals with periodontally healthy, periodontitis stage III grade C diagnoses
  • Smokers were smoking 10 cigarettes per day more than 5 years while non-smokers were never smoked.

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 OPG (pg/ml) level

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

change in salivary OPG 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 IL-34 levels from baseline to 1 month and 3 months after treatment

Salivary RANKL (pg/ml) level

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

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

Sites initially PD≥5mm

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

PD reduction in sites initially PD≥5mm

Serum OPG (pg/ml) level

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

change in serum OPG levels from baseline to 1 month and 3 months after treatment

Serum RANKL (pg/ml) level

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

change in serum RANKL levels from baseline to 1 month and 3 months after treatment

Serum IL-34 (pg/ml) level

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

change in serum IL-34 levels from baseline to 1 month and 3 months after treatment

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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