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Effect of Preoperative Periodontal Treatment on Postoperative Infection and Mortality After Aortic and Mitral Valve Surgery (Perio-CVS)

31 maggio 2026 aggiornato da: Mehmet Selim Yildiz, Istanbul University - Cerrahpasa

Effect of Preoperative Periodontal Treatment on Postoperative Infection and Mortality in Patients Undergoing Aortic and Mitral Valve Surgery: A Retrospective Study

This retrospective observational study aims to evaluate the effect of preoperative periodontal treatment on postoperative infection and mortality in patients undergoing aortic and mitral valve surgery.

Patient records between 2015 and 2024 analyzed. Demographic, clinical, and and radiographic findings, evaluated. Postoperative outcomes such as infection, antibiotic use, length of hospital and intensive care unit stay, and mortality assessed.

The findings of this study may contribute to understanding the role of periodontal health in improving postoperative outcomes in cardiac surgery patients.

Panoramica dello studio

Descrizione dettagliata

Periodontitis is a chronic inflammatory disease that has been associated with various systemic conditions, including cardiovascular diseases and infective endocarditis. Oral pathogens and inflammatory mediators originating from periodontal tissues may enter the bloodstream and contribute to systemic inflammation and postoperative complications.

This retrospective observational study includes patients aged 18 years and older who underwent aortic and mitral valve surgery and received or not periodontal treatment within 15 days prior to surgery. Patient records from 2015 to 2024 has been reviewed. Inclusion and exclusion criteria has been applied to ensure data consistency and reliability.

Collected data included demographic characteristics, medical history, periodontal disease stages, DMFT scores, and radiographic findings. Postoperative variables such as infection status, antibiotic use, duration of hospitalization, intensive care unit stay, and mortality has been evaluated.

Statistical analyses performed using appropriate parametric and non-parametric tests. Multivariate regression models used to identify factors associated with postoperative infection and mortality.

The aim of this study is to determine whether preoperative periodontal treatment has a significant impact on postoperative outcomes in patients undergoing cardiac valve surgery.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

200

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Bakirköy
      • Istanbul, Bakirköy, Turchia (Türkiye), 34147
        • Bakirköy Dr. Sadi Konuk Education and Research Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

This retrospective study population consists of adult patients who underwent cardiac valve surgery and had available preoperative panoramic radiographs and complete clinical records. The study aims to evaluate the association between oral health status (DMFT index and radiographic periodontal condition) and postoperative clinical outcomes.

Descrizione

Inclusion Criteria:

  • Adult patients (≥18 years) who underwent cardiac valve surgery
  • Availability of preoperative panoramic radiographs
  • Complete medical and dental records, including DMFT index and systemic clinical parameters
  • Patients with documented postoperative clinical follow-up data

Exclusion Criteria:

  • Patients under 18 years of age
  • Patients with incomplete or missing medical or radiographic records
  • Patients with a history of systemic conditions severely affecting bone metabolism (e.g., advanced malignancy, metabolic bone disease)
  • Patients who received recent periodontal treatment prior to radiographic assessment
  • Poor-quality radiographs that do not allow accurate evaluation

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Elective Surgery Patients
This cohort includes patients who underwent elective aortic or mitral valve surgery and had complete medical and dental records available. All patients received standard preoperative evaluation, and those with documented periodontal treatment within 15 days prior to surgery were included.
Emergency Surgery Patients
This cohort consists of patients who underwent emergency aortic or mitral valve surgery. Due to the urgent nature of the procedure, preoperative periodontal assessment and treatment not have been consistently performed.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Radiographic Alveolar Bone Loss Percentage Assessed on Panoramic Radiographs
Lasso di tempo: Preoperative assessment (baseline)
Radiographic periodontal bone loss have been assessed on panoramic radiographs by measuring the percentage of alveolar bone loss relative to root length. Bone loss severity will be categorized according to the extent of radiographic alveolar bone loss. Higher percentages indicate greater periodontal destruction and more severe periodontal disease.
Preoperative assessment (baseline)
Periodontal disease diagnosis (presence and severity)
Lasso di tempo: Preoperative assessment (baseline)
Periodontal disease diagnosed based on radiographic findings and classified according to established periodontal disease criteria (e.g., mild, moderate, or severe periodontitis).
Preoperative assessment (baseline)
DMFT index (Decayed, Missing, Filled Teeth score)
Lasso di tempo: Preoperative assessment (baseline)
The DMFT index calculated from radiographic and clinical records to quantify cumulative dental caries experience in each patient.
Preoperative assessment (baseline)
Postoperative infection-related clinical outcomes (fever duration)
Lasso di tempo: Measured within the first 7 postoperative days following cardiac surgery.
The number of days with postoperative fever (≥37.5°C) recorded from patient medical records and used as an indicator of postoperative infection.
Measured within the first 7 postoperative days following cardiac surgery.
Length of postoperative hospital stay (days)
Lasso di tempo: From the date of cardiac surgery until hospital discharge, assessed up to 30 days postoperatively.
The duration of hospitalization has been recorded in days from the date of cardiac surgery until hospital discharge and compared according to preoperative oral and periodontal status.
From the date of cardiac surgery until hospital discharge, assessed up to 30 days postoperatively.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Duration of intensive care unit (ICU) stay (days)
Lasso di tempo: From admission to the intensive care unit following cardiac surgery until ICU discharge, assessed up to 30 days postoperatively.
The number of days spent in the intensive care unit following cardiac surgery recorded and analyzed according to preoperative oral and periodontal health status.
From admission to the intensive care unit following cardiac surgery until ICU discharge, assessed up to 30 days postoperatively.
Time to initiation of oral feeding (days)
Lasso di tempo: From the date of cardiac surgery until initiation of oral feeding, assessed up to 30 days postoperatively.
The number of days from cardiac surgery to the initiation of oral feeding recorded and evaluated as an indicator of postoperative recovery.
From the date of cardiac surgery until initiation of oral feeding, assessed up to 30 days postoperatively.
Postoperative C-Reactive Protein (CRP) Level
Lasso di tempo: Measured within the first 7 postoperative days following cardiac surgery.
Serum C-reactive protein (CRP) concentration, measured in milligrams per liter (mg/L), obtained from medical records and analyzed as an indicator of postoperative systemic inflammatory response. Higher values indicate a greater inflammatory response.
Measured within the first 7 postoperative days following cardiac surgery.
Postoperative White Blood Cell (WBC) Count
Lasso di tempo: Measured within the first 7 postoperative days following cardiac surgery.
White blood cell count, measured in ×10⁹ cells/L, obtained from medical records and analyzed as an indicator of postoperative systemic inflammatory response. Higher values indicate a greater inflammatory response.
Measured within the first 7 postoperative days following cardiac surgery.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 gennaio 2015

Completamento primario (Effettivo)

1 dicembre 2024

Completamento dello studio (Effettivo)

1 maggio 2025

Date di iscrizione allo studio

Primo inviato

19 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

31 maggio 2026

Primo Inserito (Effettivo)

4 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

31 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Descrizione del piano IPD

De-identified participant data including questionnaire responses and periodontal measurements will be available upon reasonable request after publication.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • ICF
  • CODICE_ANALITICO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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