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临床试验/NCT02861937
NCT02861937已完成不适用

Estimation of Interleukin-21 Levels in Gingival Crevicular Fluid in Patients With Periodontal Health and Disease Following Non-surgical Periodontal Therapy: A Clinico-biochemical Study

Krishnadevaraya College of Dental Sciences & Hospital0 个研究点目标入组 34 人开始时间: 2014年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
34
主要终点
Plaque Index

研究概览

简要总结

Human IL-21 is present in gingival crevicular fluid in periodontal health, gingivitis and chronic periodontitis. A significant increase in the concentration of IL-21 in gingival crevicular fluid is observed with an increase in the amount of periodontal destruction. Non- surgical periodontal therapy aided in decrease of GCF IL-21 levels in clinical gingivitis and chronic periodontitis

详细描述

Introduction

Periodontal disease is a poly-microbial disease that affects tooth-supporting tissues. Integral part of periodontal disease involves destruction of periodontal tissues that results from stimulation of the bacterial challenge to host immune-inflammatory response. Chronic periodontitis is the most common form of periodontal disease in adult population. The bacterial plaque biofilm is the primitive factor for periodontitis, but the majority of destruction of the periodontal tissues would eventually conclude from a sequence of immune-inflammatory reactions. As a result of cellular activation, inflammatory mediators include cytokines, chemokines etc. collectively contribute to tissue destruction and bone resorption. Cytokines can be grouped as Th1, Th2, Th17 and T regulatory (Treg) based on their expression pattern and effects on target cells or tissues.5 Classically, periodontal disease has been explained by Th1/Th2 pathway. Th1 cells are more frequently detected in the early stage of periodontal lesions suggesting that Th1 cells are associated with a protective response against bacterial infection whereas Th2 cells predominate in the later and advanced period of the disease, having a role in the destruction and progression of periodontal lesions. Alternative type of host response to pathogenic bacteria has been described by the IL-23/IL-17 pathway. This alternative pathway occurs when bacteria induce synthesis of IL-23/17 rather than IL-12, which plays a pivotal role in initiation and maintenance of inflammatory response. IL-23/17 pathway as compared to classical Th1/Th2 pathway is a much fine tuned cellular immune response that has a multitude of functions that bridges the innate and adaptive arm of the immune response.9 Th17 cytokines (IL-17, IL-21, IL-22, IL-6, Tumor necrosis factor {TNF}-a, etc.)8 participate in periodontal disease, but whether their dominant role is host-protective or destructive is questionable. These cytokines have not been elucidated at different inflammatory status in periodontitis.

IL-21 is a type-I cytokine, structurally it appears similar to IL-2, IL-4, and IL-15 proteins. IL-21 is principally composed by activated T cells, but it directs a vast spectrum of myeloid and lymphoid cells of the immune system, which facilitate IL-21 to modulate the acquired and innate immunity.10 IL-21 compete in the immunity against tumor cells11 and chronic viral infections,12 however, enormous accomplishment of IL-21 has been correlated with the advancement of immune inflammatory diseases in various organs.13 IL-21 is heighten in dermatological conditions like skin biopsies14 of patients with systemic lupus erythematosus, psoriasis, and atopic dermatitis. In addition, IL-21 interpretation correspond with the presence of Th17 cells in synovial fluid and peripheral blood of rheumatoid arthritis patients.

Role of IL-21 in inflammation has been extensively studied; the treatment aspect on its levels in periodontal diseases needs to be further explored. Therefore, in the light of the above findings, the investigators determine the levels of interleukin-21 (IL-21) in GCF from chronic gingivitis, chronic periodontitis and control patients before and after non-surgical periodontal therapy along with the co-relation of clinical parameters of periodontal tissues destruction.

MATERIAL AND METHODS:

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • patients having more than or equal to 14 functional teeth, systemically healthy patients who had not received any form of surgical and non surgical periodontal therapy or received antibiotics or non-steroidal anti-inflammatory

排除标准

  • smokers pregnant females

结局指标

主要结局

Plaque Index

时间窗: 6 weeks

The surfaces examined are the four gingival areas of the tooth i,e the distolabial, facial, mesiolabial, and lingual surfaces. Mouth mirror, a light source, a dental explorer, and air drying of the teeth and gingiva were used. SCORE CRITERIA 0 No plaque in gingival area 1. No plaque can be observed by naked eye. A film of plaque adhering to the free gingival margin and adjacent area of the tooth recognized only by running a probe across the tooth surface. 2. Moderate accumulation of soft deposits within the gingival pockets or on the tooth and gingival margin, which can be seen with naked eye. 3. Abundance of soft matter within the gingival pocket and or on the tooth surface and gingival margin. The interdental area is stuffed with soft debris. Plaque Score:Oral Hygiene Status 0:Excellent 0.1-0.9:Good 1.0-1.9:Fair 2.0-3.0:Poor. The higher the value,worst is the outcome.

Gingival Index

时间窗: 6 weeks

The severity of Gingivitis was scored on the distolabial papillae, facial margins, mesiolabial papillae and entire lingual gingival margin of each tooth. A blunt instrument such as Periodontal probe was used to assess the bleeding. 0-Absence of inflammation/normal gingival 1. Mild inflammation, slight change in color, slight edema; no bleeding on probing 2. Moderate inflammation; moderate glazing, redness, edema and hypertrophy. Bleeding on probing.The higher the score,worst the outcome 3. Severe inflammation; marked redness, hypertrophy and ulceration. Tendency to spontaneous bleeding. Gingival Score Degree of gingivitis 0.1-1.0-Mild gingivitis 1.1-2.0-Moderate gingivitis 2.1-3.0-Severe gingivitis

Relative Attachment Level:

时间窗: 6 weeks

RAL was measured using UNC-15 periodontal probe and customized acrylic stent. This measurement was made from a fixed reference point from the occlusal surface of the acrylic stent to the base of the periodontal pocket. No Relative Attachment Level (RAL) :healthy No Relative Attachment Level (RAL) : chronic gingivitis Relative Attachment Level (RAL) more than or equal to 8mm : chronic periodontitis

Pocket Depth

时间窗: 6 weeks

Probing pocket depth (PPD) was recorded using University of North Carolina {UNC}-15 Periodontal probe and customized occlusal stent. Pocket depth was recorded from the crest of the gingival margin to the base of the pocket. The deepest probing pocket depth in the patient"s mouth was considered.

Interleukin-21(IL-21) Cytokine Levels

时间窗: 6 weeks

IL-21 levels in Gingival crevicular fluid {GCF} was determined by using ELISA kit. Quantikine human IL-21 immunoassay was done according to manufacturer"s instructions (MABTECH SWEDEN)®. ELISA reader was used to record the optical density of the tested samples.

次要结局

未报告次要终点

研究者

发起方
Krishnadevaraya College of Dental Sciences & Hospital
申办方类型
Other
责任方
Sponsor

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