Impact of Teeth Extraction on Inflammation Marker's Levels in Patients Who Undergoing Cardiac Surgery
Primary Purpose
Inflammation Gum, Cardiac Surgery
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Tooth extractions
Sponsored by
About this trial
This is an interventional prevention trial for Inflammation Gum focused on measuring Tooth Extractions, Inflammation Markers, Cardiac Surgery
Eligibility Criteria
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
Sites / Locations
- Department of Medical Sciences, University of TriesteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group One
Group Two
Arm Description
Participants receiving full mouth disinfection and extractions in one stage.
Participants receiving full mouth disinfection at stage one and extractions at stage two after 7 days.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04626011
Brief Title
Impact of Teeth Extraction on Inflammation Marker's Levels in Patients Who Undergoing Cardiac Surgery
Official Title
Impact of Total Teeth Extraction on Inflammation Marker's Levels in Patients Who Undergoing Cardiac Surgery: Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 5, 2020 (Actual)
Primary Completion Date
October 5, 2022 (Anticipated)
Study Completion Date
October 5, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Trieste
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation Gum, Cardiac Surgery
Keywords
Tooth Extractions, Inflammation Markers, Cardiac Surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
38 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group One
Arm Type
Active Comparator
Arm Description
Participants receiving full mouth disinfection and extractions in one stage.
Arm Title
Group Two
Arm Type
Active Comparator
Arm Description
Participants receiving full mouth disinfection at stage one and extractions at stage two after 7 days.
Intervention Type
Procedure
Intervention Name(s)
Tooth extractions
Other Intervention Name(s)
Inflammation markers evaluation
Intervention Description
After blood collection tests, Periodontal analysis, Orthopantomography and Anamnestic record each group will receive a full mouth disinfection and needed extractions.
Primary Outcome Measure Information:
Title
Dental protocol to be followed in patients undergoing cardiac surgery by measuring changes in serum inflammatory markers.
Description
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.
Time Frame
Changes from baseline of serum inflammatory markers after 1 day, 7 days and 14 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lorenzo Bevilacqua, DDS
Phone
00390403994787
Email
l.bevilacqua@fmc.units.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lorenzo Bevilacqua, DDS
Organizational Affiliation
Clinica Stomatologia, Piazza dell'Ospitale 1, Ospedale Maggiore 34125 Trieste Italia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medical Sciences, University of Trieste
City
Trieste
State/Province
Italy, Trieste
ZIP/Postal Code
34127
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lorenzo Bevilacqua, DDS
Phone
+39 040 399 2567
Email
l.bevilacqua@fmc.units
First Name & Middle Initial & Last Name & Degree
Lorenzo Bevilacqua, DDS
Phone
+39 040 399 2567
Email
l.bevilacqua@fmc.units.it
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31262607
Citation
Cotti E, Cairo F, Bassareo PP, Fonzar F, Venturi M, Landi L, Parolari A, Franco V, Fabiani C, Barili F, Di Lenarda A, Gulizia M, Borzi M, Campus G, Musumeci F, Mercuro G. Perioperative dental screening and treatment in patients undergoing cardio-thoracic surgery and interventional cardiovascular procedures. A consensus report based on RAND/UCLA methodology. Int J Cardiol. 2019 Oct 1;292:78-86. doi: 10.1016/j.ijcard.2019.06.041. Epub 2019 Jun 17.
Results Reference
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PubMed Identifier
29926944
Citation
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Results Reference
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PubMed Identifier
15324349
Citation
D'Aiuto F, Nibali L, Mohamed-Ali V, Vallance P, Tonetti MS. Periodontal therapy: a novel non-drug-induced experimental model to study human inflammation. J Periodontal Res. 2004 Oct;39(5):294-9. doi: 10.1111/j.1600-0765.2004.00741.x.
Results Reference
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PubMed Identifier
9030874
Citation
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Results Reference
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PubMed Identifier
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Citation
Tonetti MS, D'Aiuto F, Nibali L, Donald A, Storry C, Parkar M, Suvan J, Hingorani AD, Vallance P, Deanfield J. Treatment of periodontitis and endothelial function. N Engl J Med. 2007 Mar 1;356(9):911-20. doi: 10.1056/NEJMoa063186. Erratum In: N Engl J Med. 2018 Jun 13;:null.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
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Impact of Teeth Extraction on Inflammation Marker's Levels in Patients Who Undergoing Cardiac Surgery
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