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

April 27, 2021 updated by: Bevilacqua Lorenzo, University of Trieste

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Italy, Trieste
      • Trieste, Italy, Trieste, Italy, 34127
        • Recruiting
        • Department of Medical Sciences, University of Trieste
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group One
Participants receiving full mouth disinfection and extractions in one stage.
Procedure: Tooth extractions
After blood collection tests, Periodontal analysis, Orthopantomography and Anamnestic record each group will receive a full mouth disinfection and needed extractions.
Other Names:
  • Inflammation markers evaluation
ACTIVE_COMPARATOR: Group Two
Participants receiving full mouth disinfection at stage one and extractions at stage two after 7 days.
Procedure: Tooth extractions
After blood collection tests, Periodontal analysis, Orthopantomography and Anamnestic record each group will receive a full mouth disinfection and needed extractions.
Other Names:
  • Inflammation markers evaluation

What is the study measuring?

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Trieste

Investigators

  • Principal Investigator: Lorenzo Bevilacqua, DDS, Clinica Stomatologia, Piazza dell'Ospitale 1, Ospedale Maggiore 34125 Trieste Italia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 5, 2020

Primary Completion (ANTICIPATED)

October 5, 2022

Study Completion (ANTICIPATED)

October 5, 2022

Study Registration Dates

First Submitted

October 5, 2020

First Submitted That Met QC Criteria

November 8, 2020

First Posted (ACTUAL)

November 12, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 3, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BLorenzo

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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