Effect of Preoperative Periodontal Treatment on Postoperative Infection and Mortality After Aortic and Mitral Valve Surgery (Perio-CVS)
31 de mayo de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Descripción detallada
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 de estudio
De observación
Inscripción (Actual)
200
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Bakirköy
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Istanbul, Bakirköy, Turquía (Türkiye), 34147
- Bakirköy Dr. Sadi Konuk Education and Research Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Radiographic Alveolar Bone Loss Percentage Assessed on Panoramic Radiographs
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Duration of intensive care unit (ICU) stay (days)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de enero de 2015
Finalización primaria (Actual)
1 de diciembre de 2024
Finalización del estudio (Actual)
1 de mayo de 2025
Fechas de registro del estudio
Enviado por primera vez
19 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
31 de mayo de 2026
Publicado por primera vez (Actual)
4 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
31 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2025/168
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
De-identified participant data including questionnaire responses and periodontal measurements will be available upon reasonable request after publication.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- CIF
- CÓDIGO_ANALÍTICO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .