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

NCT04626011 | Unknown

• 1 other identifier: BLorenzo
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation Gum; Cardiac Surgery

Keywords

Tooth Extractions; Inflammation Markers; Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Group One

ACTIVE COMPARATOR

Participants receiving full mouth disinfection and extractions in one stage.

Procedure: Tooth extractions

Group Two

ACTIVE COMPARATOR

Participants receiving full mouth disinfection at stage one and extractions at stage two after 7 days.

Procedure: Tooth extractions

Interventions

Tooth extractions PROCEDURE

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

Also known as: Inflammation markers evaluation

Group One; Group Two

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Trieste: lead

Study Sites (1)

Department of Medical Sciences, University of Trieste

Trieste, Italy, Trieste, 34127, Italy

RECRUITING

Related Publications (6)

• 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.

  PMID: 31262607 BACKGROUND

• 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.

  PMID: 29926944 BACKGROUND

• 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.

  PMID: 15324349 BACKGROUND

• 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. doi: 10.1111/j.1365-2249.1997.270-ce1162.x.

  PMID: 9030874 BACKGROUND

• 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.

  PMID: 17329698 BACKGROUND

• 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. doi: 10.1902/jop.2000.71.10.1528.

  PMID: 11063384 BACKGROUND

MeSH Terms

Conditions

Gingivitis

Interventions

Tooth Extraction

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures; Surgical Procedures, Operative; Dentistry

Study Officials

• Lorenzo Bevilacqua, DDS

  Clinica Stomatologia, Piazza dell'Ospitale 1, Ospedale Maggiore 34125 Trieste Italia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lorenzo Bevilacqua, DDS

CONTACT

00390403994787; l.bevilacqua@fmc.units.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor, DDS, MsC

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: November 12, 2020
• Study Start: October 5, 2020
• Primary Completion: October 5, 2022
• Study Completion: October 5, 2022
• Last Updated: May 3, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)