跳至主要内容
临床试验/NCT04626011
NCT04626011Unknown不适用

Impact of Total Teeth Extraction on Inflammation Marker's Levels in Patients Who Undergoing Cardiac Surgery: Clinical Trial.

University of Trieste2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2020年10月5日最近更新:
适应症

试验速览

阶段
不适用
入组人数
38
试验地点
2
主要终点
Dental protocol to be followed in patients undergoing cardiac surgery by measuring changes in serum inflammatory markers.

研究概览

简要总结

The aim of this study is to examine effects of dental treatments, surgical (extractions) and non-surgical procedures (non-surgical periodontal therapy), on serum levels for PCR, WBCs and PCT in patients needing a dental remediation before undergoing cardiac surgery.

详细描述

Introduction. The association between periodontal disease and cardiovascular disease is already established. Chronic inflammation of periodontal tissues primes the release of inflammatory markers such as: PCR, IL-1, IL-6 and TNF alpha and also,an even more accurate marker, procalcitonin (PCT).

Aim. The aim of this study is to examine effects of dental treatments, surgical (extractions) and non-surgical procedures (non-surgical periodontal therapy), on serum levels for PCR, WBCs and PCT in patients needing a dental remediation before undergoing cardiac surgery.

Materials and methods. This study is designed to be a clinical trial. 38 patients will be recruited at the Cardiological Center at Cattinara Hospital (ASUITS) and they will be treated in Maxillofacial Surgery and Stomatology Clinic at Major Hospital (ASUITS). Inclusion criteria: adult age, consciousness and willingness to sign an informed consent, anamnestic history of cardiovascular disease, also needing cardiac surgery and dental reclamation, stage 3-4 grade B-C for periodontal disease diagnosed . Exclusion criteria: pregnancy, genetic dysmorphisms which have an impact on the periodontal health status (Down Syndrome), diabetes or immune system disorders, HIV, hardly smoking, blood disorders, urgent cardiac surgery or a too large dental remediation to be performed in just 2 dental sessions, patients who underwent dental treatments in the previous 2 months. At baseline, all patients will undergo blood tests (blood cell count, PCR, PCT and WBC count), periodontal analysis (FMPS, FMBS and PISA index recording), orthopantomography and anamnestic record. Afterwards they will be assigned, randomly following a 1:1 ratio to Gruppo1 (fullmouth disinfection therapy + extractions all in one session) or Gruppo2 (fullmouth disinfection therapy and after one week extractions). All patients will undergo blood chemistry tests (CPR, PCT, WBC) after 1, 7 and 14 days.

Statistical analysis. All data will be presented as a mean and standard deviation, unless another method will be specified. After the control of parametric data distribution we will proceed with the statistical analysis of the different biomarkers recorded over time by ANOVA for repeated measurements and by t-test between the different groups in the same time intervals.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • adult age, consciousness and willingness to sign an informed consent, anamnestic history of cardiovascular disease, also needing cardiac surgery and dental reclamation, stage 3-4 grade B-C for periodontal disease diagnosed

排除标准

  • pregnancy, genetic dysmorphisms which have an impact on the periodontal health status (Down Syndrome), diabetes or immune system disorders, HIV, hardly smoking, blood disorders, urgent cardiac surgery or a too large dental remediation to be performed in just 2 dental sessions, patients who underwent dental treatments in the previous 2 months

结局指标

主要结局

Dental protocol to be followed in patients undergoing cardiac surgery by measuring changes in serum inflammatory markers.

时间窗: Changes from baseline of serum inflammatory markers after 1 day, 7 days and 14 days.

To find out which dental procedures protocol to be used to reduce serum inflammation markers as TNF alfa, IL 6, CPR, WBC and PCT values in patient undergoing cardiac surgery using a sample of 38 patients.

次要结局

未报告次要终点

研究者

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

Bevilacqua Lorenzo

Clinical professor, DDS, MsC

University of Trieste

研究点 (2)

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