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

Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04626011
• Other study ID #: BLorenzo
• Status: Recruiting
• Phase: N/A
• Start date: October 5, 2020
• Est. completion date: October 5, 2022

Study information

• Verified date: April 2021
• Source: University of Trieste
• Contact: Lorenzo Bevilacqua, DDS
• Phone: 00390403994787
• Email: l.bevilacqua[@]fmc.units.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: October 5, 2022
• Est. primary completion date: October 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Surgery
• Gingivitis
• Inflammation
• Inflammation Gum

Intervention

Procedure:
• Tooth extractions
After blood collection tests, Periodontal analysis, Orthopantomography and Anamnestic record each group will receive a full mouth disinfection and needed extractions.

Locations

Country	Name	City	State
Italy	Department of Medical Sciences, University of Trieste	Trieste	Italy, Trieste

Sponsors (1)

Lead Sponsor	Collaborator
University of Trieste

Country where clinical trial is conducted

Italy, 

References & Publications (6)

Chapple ILC, Mealey BL, Van Dyke TE, Bartold PM, Dommisch H, Eickholz P, Geisinger ML, Genco RJ, Glogauer M, Goldstein M, Griffin TJ, Holmstrup P, Johnson GK, Kapila Y, Lang NP, Meyle J, Murakami S, Plemons J, Romito GA, Shapira L, Tatakis DN, Teughels W, Trombelli L, Walter C, Wimmer G, Xenoudi P, Yoshie H. Periodontal health and gingival diseases and conditions on an intact and a reduced periodontium: Consensus report of workgroup 1 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol. 2018 Jun;89 Suppl 1:S74-S84. doi: 10.1002/JPER.17-0719. — View 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. — View 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. — View Citation

Ebersole JL, Machen RL, Steffen MJ, Willmann DE. Systemic acute-phase reactants, C-reactive protein and haptoglobin, in adult periodontitis. Clin Exp Immunol. 1997 Feb;107(2):347-52. — View Citation

Loos BG, Craandijk J, Hoek FJ, Wertheim-van Dillen PM, van der Velden U. Elevation of systemic markers related to cardiovascular diseases in the peripheral blood of periodontitis patients. J Periodontol. 2000 Oct;71(10):1528-34. — View 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. Erratum in: N Engl J Med. 2018 Jun 13;:null. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.