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临床试验/NCT04980768
NCT04980768Unknown不适用

Association of Apical Periodontitis With Systemic Levels of Hs-CRP and Hemogram Indices: A Clinical Study.

Postgraduate Institute of Dental Sciences Rohtak2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
25
试验地点
2
主要终点
Hemogram indices

研究概览

简要总结

There is lack of evidence on resolution of signs of systemic inflammatory markers by successful elimination of periapical inflammation by endodontic treatment. Complete blood count (CBC) may have potential to detect various inflammatory conditions but its use for this purpose is sparsely reported. To the best of our knowledge effect of chronic apical periodontitis on various parameters of complete blood count has not been studied.

详细描述

Prevalence of Apical periodontitis (AP) is reported in the range of 17% to 65% with higher prevalence reported in older patients. Infection of the pulp tissue of the affected tooth is the principal cause of apical periodontitis and it is characterised by inflammation of the periradicular tissues. Presentation of AP varies from classical signs of inflammation (pain, swelling, loss of function) to being completely asymptomatic with only signs of apical bone resorption on the radiograph. Histological changes seen in AP is localized infiltration of inflammatory cells and bone resorptions. AP can be treated by root canal treatment (RCT) which comprises elimination of microbes and their toxic products followed by filling of the root canal by an inert material. It also acts to limit the spread of microbial infection seen in AP to jaw and the other parts of the body.

Apical periodontics if left untreated can cause serious complications. Infection and loss of function caused by loss of teeth may jeopardize overall health of the patients. Chronic infection like untreated AP may also influence development and progression of other serious conditions. Numerous inflammatory mediators are responsible for eliciting inflammatory reactions seen in AP for example both IL-1beta and TNF-alpha are found in periapical lesions and IL-1beta is suggested to cause greater bone resorption in patients of AP. Role of these mediators in AP is to cause vasodilation, increased vascular permeability and recruit other inflammatory cells. It is also been suggested that increased inflammatory mediators seen in AP may also enhance the systemic inflammation. Inflammation induced tissue damage may vary in different disease, however the markers that trigger this damage are very similar. They all act to increase the rate of the inflammatory process, cause tissue destruction and may even be involved in development of clinical symptoms. For example, markers like hsCRP is associated with various steps of atherogenesis and is also found elevated in AP. Studies have reported significantly higher levels of endothelial dysfunction in patients of apical periodontitis which were found to reduce to normal level following root canal treatment.

A recent systematic review has found significant difference in levels of CRP and IL-6 in AP subjects than control. IL-6 plays role in initiation of autoimmune disease and chronic inflammation and also contributes in low grade systemic inflammation. The same systematic review and meta-analysis has found only eight interventional study that studied effect on inflammatory marker before and after treatment. The data from these studies were also heterogenous with wide variety of treatment reported. Only two studies are available which has evaluated effect of endodontic treatment on levels of isolated groups of inflammatory mediators and stress markers like reactive oxygen species and circulatory immune complex. TNF- α is indicated to be responsible for adverse pregnancy outcome and along with CRP may enhance the insulin resistance. Similarly, complete hemogram indices like mean platelet volume, neutrophil-lymphocyte ratio is altered in chronic inflammatory conditions and their estimation could be useful in evaluating overall systemic inflammatory burden of patients of AP. To the best of our knowledge no study so far has evaluated effect of non-surgical root canal treatment on the levels of hsCRP and complete hemogram parameters. Therefore, this study proposes to compare these markers in patients of AP and healthy control and also before and two years after root canal treatment.

Medical and Dental Examination Prior to treatment a detailed medical and dental history will be recorded. Oral clinical examinations will include hard and soft tissue evaluation. Pulp sensibility test will be carried out along with percussion and palpation of the affected tooth. The periapical radiographic examinations will be carried out at standard exposure parameters to detect apical bone resorption. Periodontal clinical parameters will be evaluated at 6 sites in all teeth, including probing depths (PDs), the clinical attachment level, and bleeding on probing at the base of the crevice, excluding third molars. The periodontal assessment will be made with a manual periodontal probe (UNC 15; Hu-Friedy, Chicago, IL).

Blood Samples and Laboratory Analysis Fasting blood samples will be obtained by venipuncture of the ante-cubital vein. Blood sample will be submitted to the clinical laboratory of the Department of Biochemistry PGIMS and Department of Oral Pathology, PGIDS, Rohtak, Haryana for the quantitative analysis of hs-CRP and complete hemogram analysis respectively.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Pulpal necrosis in mature mandibular molar as confirmed by negative response to pulp sensibility test (cold and electric pulp test)
  • Radiographic evidence of apical periodontitis in the form of periapical radiolucency
  • Radiographic alveolar bone breakdown not more than one third of root length.

排除标准

  • Obese (BMI >30 kg/m2), smoker, pregnant, diabetic, immunocompromised or have any other systemic inflammatory condition.
  • Having a positive history of antibiotic use within the past month or require antibiotic premedication for dental treatment (including infective endocarditis or prosthetic joint prophylaxis).
  • Teeth having previous root fillings, unrestorable teeth, fractured/perforated roots, grade 3 mobility, and history of recent periodontal therapy (within previous 6 months).
  • Teeth with established endodontic-periodontal lesions exhibiting <2 mm radiopaque bone between the root apex.

结局指标

主要结局

Hemogram indices

时间窗: Baseline-3 months

Complete hemogram parameters in percentage will be assessed using automated machine.

Level of hs-CRP

时间窗: Baseline-3 months

Serum level of hs-CRP will be measured using ELISA in g/dl.

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 (2)

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