PeriodontitisPerio-CVSNCT07626801
Effect of Preoperative Periodontal Treatment on Postoperative Infection and Mortality After Aortic and Mitral Valve Surgery
An observational study of Periodontitis and Heart Valve Disease, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis, Heart Valve Disease, Postoperative Infection
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2015to 1 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakirköy Dr. Sadi Konuk Education and Research Hospital
Istanbul, Bakirköy, 34147
About this study
Official title: 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.
Read the detailed description
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.
- Keywords
- Preoperative Periodontal Treatment, Cardiac Valve Surgery, Periodontal Disease, Postoperative Infection, Retrospective Study
- Medical subject headings
- Periodontitis, Heart Valve Diseases, Cardiovascular Diseases, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Alveolar Bone Loss Percentage Assessed on Panoramic Radiographs
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.
Measured: Preoperative assessment (baseline)
Periodontal disease diagnosis (presence and severity)
Periodontal disease diagnosed based on radiographic findings and classified according to established periodontal disease criteria (e.g., mild, moderate, or severe periodontitis).
Measured: Preoperative assessment (baseline)
DMFT index (Decayed, Missing, Filled Teeth score)
The DMFT index calculated from radiographic and clinical records to quantify cumulative dental caries experience in each patient.
Measured: Preoperative assessment (baseline)
Postoperative infection-related clinical outcomes (fever duration)
The number of days with postoperative fever (≥37.5°C) recorded from patient medical records and used as an indicator of postoperative infection.
Measured: Measured within the first 7 postoperative days following cardiac surgery.
Length of postoperative hospital stay (days)
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.
Measured: From the date of cardiac surgery until hospital discharge, assessed up to 30 days postoperatively.
Secondary outcomes (4)
Duration of intensive care unit (ICU) stay (days)
The number of days spent in the intensive care unit following cardiac surgery recorded and analyzed according to preoperative oral and periodontal health status.
Measured: 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)
The number of days from cardiac surgery to the initiation of oral feeding recorded and evaluated as an indicator of postoperative recovery.
Measured: From the date of cardiac surgery until initiation of oral feeding, assessed up to 30 days postoperatively.
Postoperative C-Reactive Protein (CRP) Level
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: Measured within the first 7 postoperative days following cardiac surgery.
Postoperative White Blood Cell (WBC) Count
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: Measured within the first 7 postoperative days following cardiac surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start1 Jan 2015
- Primary completion1 Dec 2024
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Selim Yildiz, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07626801
- Sponsor's protocol ID
- 2025/168
- Acronym
- Perio-CVS
- Status last verified
- May 2026
- First submitted
- 19 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data including questionnaire responses and periodontal measurements will be available upon reasonable request after publication.
Publications
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.
PubMed 19121072Sfyroeras 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.
PubMed 22244863Saengtipbovorn 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.
PubMed 24934646Nishimura 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.
PubMed 28315732Hajishengallis G. Periodontitis: from microbial immune subversion to systemic inflammation. Nat Rev Immunol. 2015 Jan;15(1):30-44. doi: 10.1038/nri3785.
PubMed 25534621Bagyi 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.
PubMed 19563632
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Periodontal Treatment on Postoperative Infection and Mortality in Patients Undergoing Aortic and Mitral Valve Surgery: A Retrospective Study
- ClinicalTrials.gov ID
- NCT07626801
- Acronym / sponsor ID
- Perio-CVS / 2025/168
- Keywords
- Preoperative Periodontal Treatment, Cardiac Valve Surgery, Periodontal Disease, Postoperative Infection, Retrospective Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Radiographic Alveolar Bone Loss Percentage Assessed on Panoramic Radiographs
Time frame: 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.
Periodontal disease diagnosis (presence and severity)
Time frame: 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).
DMFT index (Decayed, Missing, Filled Teeth score)
Time frame: Preoperative assessment (baseline)
The DMFT index calculated from radiographic and clinical records to quantify cumulative dental caries experience in each patient.
Postoperative infection-related clinical outcomes (fever duration)
Time frame: 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.
Length of postoperative hospital stay (days)
Time frame: 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.
4 secondary outcomes
Duration of intensive care unit (ICU) stay (days)
Time frame: 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)
Time frame: From the date of cardiac surgery until initiation of oral feeding, assessed up to 30 days postoperatively.
Postoperative C-Reactive Protein (CRP) Level
Time frame: Measured within the first 7 postoperative days following cardiac surgery.
Postoperative White Blood Cell (WBC) Count
Time frame: Measured within the first 7 postoperative days following cardiac surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Results publication: PubMed 19121072Nakano 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.
- Results publication: PubMed 22244863Sfyroeras 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.
- Results publication: PubMed 24934646Saengtipbovorn 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.
- Results publication: PubMed 28315732Nishimura 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.
- Results publication: PubMed 25534621Hajishengallis G. Periodontitis: from microbial immune subversion to systemic inflammation. Nat Rev Immunol. 2015 Jan;15(1):30-44. doi: 10.1038/nri3785.
- Results publication: PubMed 19563632Bagyi 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.
- Individual participant dataSharing planned: Yes. De-identified participant data including questionnaire responses and periodontal measurements will be available upon reasonable request after publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis and Heart Valve Disease, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic Alveolar Bone Loss Percentage Assessed on Panoramic Radiographs (time frame: Preoperative assessment (baseline)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07626801, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.