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Bacteremia From Periodontal Treatment to Elucidate the Underpinnings of Sepsis

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion date: Dec 31, 2026 to Dec 31, 2027
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v5
  2. Study completion date: Dec 31, 2026 to Dec 31, 2027
    • Study description shortened, about 13 words
    v4
  3. Primary completion date: Dec 31, 2023 to Dec 31, 2026
    • Study completion date: Dec 31, 2024 to Dec 31, 2026
    v3
  4. Primary completion date: Dec 31, 2022 to Dec 31, 2023
    • Study completion date: Dec 31, 2022 to Dec 31, 2024
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Malmö University
20 trials monitored
See 1 trial at risk
Heart Disease
8,786 trials monitored
See 412 trials at risk
Approximately 40,000 Swedes suffer from sepsiseach year, about 20% die. Biomarkers that are sensitive to current or previous bacteremia are needed in the treatment of sepsis. Bacteremia from periodontal treatment is predictive and occurs in 13-75%. Cardiovascular disease (CVD) is the number one cause of death in industrialized countries and the impact of bacteria and their products need to be elucidated. The study's hypothesis is to utilize bacteremia from periodontal treatment to evaluate biological markers for current or previous bacteremia. A. What are the long term clinical, and 'omics related CVD-phenotypical effects from treating periodontal disease compared to an untreated group? B. Can biomarkers be used for detecting a bacteremia or previous bacteremia? C. Are the effects from bacteremia on cardiovascular biomarkers related to the individual's antimicrobial peptide profile? D. Does the presence of bacterial proteases, such as gingipain, relate to having a bacteremia from periodontal treatment and the systemic response from a bacteremia? Significance: The project has the potential to shorten the time to treat sepsis, which in turn shortens hospital stay and higher survival. The possible definition of protective AMP-profile could translate to future pharmacologic intervention and improve the treatment of sepsis as well as prophylactic treatment at dental treatments. An elucidation of the impact of bacteria and their products on CVD could lead to personalized medicine targeting anti-inflammation and anti-oxidative stress in subjects with periodontitis. As of March 2024 78 subjects have been included and we anticipate to keep the time-line that we set up.
Trial Details
NCT Number NCT04565691
Lead Sponsor Malmö University
Collaborators: Skane University Hospital, Swedish Dental Service Organisation
Conditions
(from sponsor)		 Bacteremia, Periodontal Diseases, Sepsis, Heart Diseases
Related terms Bacteremia, Heart Diseases, Periodontal Diseases, Sepsis
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov