Bacteremia From Periodontal Treatment to Elucidate the Underpinnings of Sepsis

NCT04565691 | Active Not Recruiting DMC

• 1 other identifier: Lund university
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bacteremia; Periodontal Diseases; Sepsis; Heart Diseases

Keywords

Bacteremia; Periodontal disease; Sepsis; Heart Disease

Outcome Measures

Primary Outcomes (1)

• Bacteremia

  Changes in positive blood culture

  At baseline, periodontal treatment (within 5 min) and 1 hour, 1 day, 1 week and 1 year after periodontal treatment.

Secondary Outcomes (1)

• Changes in levels of biomarkers in relation to bacteremia

  At baseline, periodontal treatment (within 5 min) and 1 hour, 1 day, 1 week and 1 year after periodontal treatment.

Study Arms (1)

Bacteremia inducing arm

EXPERIMENTAL

As mentioned the participants will be their own controls at the different time-points.

Procedure: Non-surgical periodontal treatment

Interventions

Non-surgical periodontal treatment PROCEDURE

Non-surgical periodontal treatment that is accepted to cause bacteremia in about 40% of the cases.

Bacteremia inducing arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Periodontal disease

You may not qualify if:

• Recently used antibiotics.

Sponsors & Collaborators

• Malmö University: lead
• Skane University Hospital: collaborator
• Swedish Dental Service Organisation: collaborator

Study Sites (1)

Folktandvarden Skane

Lund, Sweden

Location

MeSH Terms

Conditions

Bacteremia; Periodontal Diseases; Sepsis; Heart Diseases

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mouth Diseases; Stomatognathic Diseases; Cardiovascular Diseases

Study Officials

• Daniel Jonsson, DDS PhD

  Malmo University, Lund University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: We study the impact of bacteremia. The subjects will be their own controls at the different time-points.

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: September 25, 2020
• Study Start: February 25, 2019
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

SE (1)