Impact of Teeth Extraction on Inflammation Marker's Levels in Patients Who Undergoing Cardiac Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Inflammation Gum, Cardiac Surgery

Intervention / Treatment
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* Procedure: Tooth extractions


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group One<br>Participants receiving full mouth disinfection and extractions in one stage. | Procedure: Tooth extractions<br>* After blood collection tests, Periodontal analysis, Orthopantomography and Anamnestic record each group will receive a full mouth disinfection and needed extractions.<br>* Other names: Inflammation markers evaluation;|
| Active Comparator: Group Two<br>Participants receiving full mouth disinfection at stage one and extractions at stage two after 7 days. | Procedure: Tooth extractions<br>* After blood collection tests, Periodontal analysis, Orthopantomography and Anamnestic record each group will receive a full mouth disinfection and needed extractions.<br>* Other names: Inflammation markers evaluation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dental protocol to be followed in patients undergoing cardiac surgery by measuring changes in serum inflammatory markers. | 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. | Changes from baseline of serum inflammatory markers after 1 day, 7 days and 14 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Surgery, Tooth Extractions, Inflammation Markers