- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07626801
Effect of Preoperative Periodontal Treatment on Postoperative Infection and Mortality After Aortic and Mitral Valve Surgery (Perio-CVS)
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.
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Bakirköy
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Istanbul, Bakirköy, Turecko (Türkiye), 34147
- Bakirköy Dr. Sadi Konuk Education and Research Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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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.
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Radiographic Alveolar Bone Loss Percentage Assessed on Panoramic Radiographs
Časové okno: Preoperative assessment (baseline)
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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.
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Preoperative assessment (baseline)
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Periodontal disease diagnosis (presence and severity)
Časové okno: Preoperative assessment (baseline)
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Periodontal disease diagnosed based on radiographic findings and classified according to established periodontal disease criteria (e.g., mild, moderate, or severe periodontitis).
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Preoperative assessment (baseline)
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DMFT index (Decayed, Missing, Filled Teeth score)
Časové okno: Preoperative assessment (baseline)
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The DMFT index calculated from radiographic and clinical records to quantify cumulative dental caries experience in each patient.
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Preoperative assessment (baseline)
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Postoperative infection-related clinical outcomes (fever duration)
Časové okno: Measured within the first 7 postoperative days following cardiac surgery.
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The number of days with postoperative fever (≥37.5°C)
recorded from patient medical records and used as an indicator of postoperative infection.
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Measured within the first 7 postoperative days following cardiac surgery.
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Length of postoperative hospital stay (days)
Časové okno: From the date of cardiac surgery until hospital discharge, assessed up to 30 days postoperatively.
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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.
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From the date of cardiac surgery until hospital discharge, assessed up to 30 days postoperatively.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Duration of intensive care unit (ICU) stay (days)
Časové okno: From admission to the intensive care unit following cardiac surgery until ICU discharge, assessed up to 30 days postoperatively.
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The number of days spent in the intensive care unit following cardiac surgery recorded and analyzed according to preoperative oral and periodontal health status.
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From admission to the intensive care unit following cardiac surgery until ICU discharge, assessed up to 30 days postoperatively.
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Time to initiation of oral feeding (days)
Časové okno: From the date of cardiac surgery until initiation of oral feeding, assessed up to 30 days postoperatively.
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The number of days from cardiac surgery to the initiation of oral feeding recorded and evaluated as an indicator of postoperative recovery.
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From the date of cardiac surgery until initiation of oral feeding, assessed up to 30 days postoperatively.
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Postoperative C-Reactive Protein (CRP) Level
Časové okno: Measured within the first 7 postoperative days following cardiac surgery.
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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.
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Measured within the first 7 postoperative days following cardiac surgery.
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Postoperative White Blood Cell (WBC) Count
Časové okno: Measured within the first 7 postoperative days following cardiac surgery.
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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.
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Measured within the first 7 postoperative days following cardiac surgery.
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Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- Hajishengallis G. Periodontitis: from microbial immune subversion to systemic inflammation. Nat Rev Immunol. 2015 Jan;15(1):30-44. doi: 10.1038/nri3785.
- Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Fleisher LA, Jneid H, Mack MJ, McLeod CJ, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A. 2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2017 Jul 11;70(2):252-289. doi: 10.1016/j.jacc.2017.03.011. Epub 2017 Mar 15. No abstract available.
- Nakano K, Nemoto H, Nomura R, Inaba H, Yoshioka H, Taniguchi K, Amano A, Ooshima T. Detection of oral bacteria in cardiovascular specimens. Oral Microbiol Immunol. 2009 Feb;24(1):64-8. doi: 10.1111/j.1399-302X.2008.00479.x.
- Sfyroeras GS, Roussas N, Saleptsis VG, Argyriou C, Giannoukas AD. Association between periodontal disease and stroke. J Vasc Surg. 2012 Apr;55(4):1178-84. doi: 10.1016/j.jvs.2011.10.008. Epub 2012 Jan 14.
- Saengtipbovorn S, Taneepanichskul S. Effectiveness of lifestyle change plus dental care (LCDC) program on improving glycemic and periodontal status in the elderly with type 2 diabetes. BMC Oral Health. 2014 Jun 16;14:72. doi: 10.1186/1472-6831-14-72.
- Bagyi K, Haczku A, Marton I, Szabo J, Gaspar A, Andrasi M, Varga I, Toth J, Klekner A. Role of pathogenic oral flora in postoperative pneumonia following brain surgery. BMC Infect Dis. 2009 Jun 29;9:104. doi: 10.1186/1471-2334-9-104.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2025/168
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- ICF
- ANALYTIC_CODE
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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