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临床试验/NCT05962567
NCT05962567招募中不适用

Effect of Non-surgical Periodontal Therapy on Interleukin-34 Level in Gingival Crevicular Fluid in Patients With Periodontal Disease (Controlled Clinical Trial)

Ain Shams University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
1- To measure the IL - 34 levels in ng/L in GCF before &after Non-Surgical Periodontal Therapy of stage II periodontitis patients and compare it to healthy individuals

研究概览

简要总结

Aim of the study:

  1. To investigate changes in the levels of Interleukin 34 (IL-34) in the Gingival crevicular fluid(GCF) of patients with stage II periodontitis patients before and after nonsurgical periodontal therapy and compare it with healthy individuals
  2. To correlate changes in Gingival crevicular fluid level of Interleukin 34 with changes in periodontal parameters after nonsurgical periodontal therapy

详细描述

Periodontal disease is a chronic disease of various inflammatory diseases where the early symptoms are gingival redness, swelling, and bleeding. As the disease progresses, periodontal pockets, clinical attachment loss (CAL) as well as alveolar bone resorption may occur. If left untreated, periodontal disease can lead to loss of teeth which directly affects patient's mastication.

A new system of periodontal classification has been adopted, in which the types of disease that were previously identified as "chronic" or "aggressive" Armitage, 1999 are now classified under one category ("periodontitis") and re-diagnosed on the basis of many variants (staging and grading system).

The stage is based on the severity of the disease and the complexity of the disease management (in terms of loss of clinical attachment between teeth (CAL), radiographic bone loss, and tooth loss), complexity, and size and distribution. Grading provides additional information about the biological features of the disease, including history-based analysis of the progression rate of periodontitis; progression risk assessment; analysis of possible adverse effects of treatment; and risk assessment that the disease or its treatment may adversely affect the patient's normal life.

Periodontitis is described in four stages ranging from Stage I: Initial periodontitis (CAL 1-2mm), Stage II: Moderate periodontitis (CAL 3-4 mm), Stage III: Severe periodontitis with potential for additional tooth loss (<4), and(CAL≥5mm) Stage IV: Severe periodontitis with potential for loss of dentition (≥5) and (CAL≥5mm). Grading focuses on assessing risk factors like smoking, diabetes, and outcomes of scaling and root debridement. Grade A: Slow rate of progression (no CAL loss over 5 years), Grade B: Moderate rate of progression (CAL loss<2mm over 5years), and Grade C: Rapid rate of progression (CAL loss ≥2 mm over 5 years).

Periodontitis occurs due to a complex of genetic, environmental, and bacterial interaction in which bacterial and host factors play an important role. The imbalance between the previous two factors results in a completely different change from health state to inflammatory disease and once inflammation has begun, activation of many cytokines and molecular mechanisms occur.

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
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with stage II Periodontitis.
  • Both genders aged from 20-50 years
  • Minimum 20 natural teeth excluding third molars
  • Good compliance with the plaque control instructions following initial therapy.
  • Availability for follow-up and maintenance program.

排除标准

  • Pregnant and lactating females.
  • Systemic diseases that could affect the outcome of the therapy (According to Cornell Medical Index-Health Questionnaire).
  • Patients taking antibiotics, anti-inflammatory, and immunosuppressive therapy during the preceding 3 months before the start of the trial and during the study.
  • Patients who have undergone any periodontal therapy in the last 6 months
  • Vulnerable groups of patients e.g. (handicapped patients).

结局指标

主要结局

1- To measure the IL - 34 levels in ng/L in GCF before &after Non-Surgical Periodontal Therapy of stage II periodontitis patients and compare it to healthy individuals

时间窗: 3 months

1- To measure the IL - 34 levels in ng/L in GCF before \&after Non-Surgical Periodontal Therapy of stage II periodontitis patients and compare it to healthy individuals

次要结局

  • To evaluate Probing depth before & after Non-Surgical Periodontal Therapy of stage II periodontitis patients(3 months)
  • To evaluate Clinical attachment level before & after Non-Surgical Periodontal Therapy of stage II periodontitis patients(3 months)
  • To evaluate Plaque index before & after Non-Surgical Periodontal Therapy of stage II periodontitis patients(3 months)
  • To evaluate Gingival index before & after Non-Surgical Periodontal Therapy of stage II periodontitis patients(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nada Zidan

MSc student

Ain Shams University

研究点 (1)

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