NCT07626801

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 19, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 4, 2026

Completed
Last Updated

June 4, 2026

Status Verified

May 1, 2026

Enrollment Period

9.9 years

First QC Date

May 19, 2026

Last Update Submit

May 31, 2026

Conditions

Keywords

Preoperative Periodontal TreatmentCardiac Valve SurgeryPeriodontal DiseasePostoperative InfectionRetrospective Study

Outcome Measures

Primary Outcomes (5)

  • 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.

    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).

    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.

    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 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.

    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)

    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)

    From the date of cardiac surgery until initiation of oral feeding, assessed up to 30 days postoperatively.

  • Postoperative C-Reactive Protein (CRP) Level

    Measured within the first 7 postoperative days following cardiac surgery.

  • Postoperative White Blood Cell (WBC) Count

    Measured within the first 7 postoperative days following cardiac surgery.

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bakirköy Dr. Sadi Konuk Education and Research Hospital

Istanbul, Bakirköy, 34147, Turkey (Türkiye)

Location

Related Publications (6)

  • 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.

  • 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.

  • Hajishengallis G. Periodontitis: from microbial immune subversion to systemic inflammation. Nat Rev Immunol. 2015 Jan;15(1):30-44. doi: 10.1038/nri3785.

  • 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.

MeSH Terms

Conditions

PeriodontitisHeart Valve DiseasesCardiovascular DiseasesPeriodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesHeart Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 19, 2026

First Posted

June 4, 2026

Study Start

January 1, 2015

Primary Completion

December 1, 2024

Study Completion

May 1, 2025

Last Updated

June 4, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, ICF, ANALYTIC CODE

Locations