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PeriodontitisNCT01045070

Periodontitis and Coronary Heart Disease

An observational study of Periodontitis and Coronary Heart Disease, run by Martin-Luther-Universität Halle-Wittenberg at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

"Atherosclerosis is an inflammatory disease". The hypothesis of an infectious burden as trigger or initiator of the inflammatory process in atherosclerosis has been extensively discussed in the past years. One part of this discussion is focused on the infectious agents responsible for periodontitis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Periodontitis, Coronary Heart Disease
How many people
960 participants
Where
1 siteGermany
Study dates
Oct 2009to May 2012
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: Patients with coronary heart disease, admitted to the Martin Luther-University Halle-Wittenberg

Who may be able to join

  • Age >18 years
  • Coronary heart disease as defined by previous or current detection of 50% stenosis of a main coronary artery by coronary angiography or previous or current percutaneous coronary intervention (PCI) or previous or current coronary artery bypass surgery (CABG)

Who cannot join

  • Inability to give written informed consent
  • Periodontal treatment and/or antibiotic therapy during the last 6 months
  • Pregnancy
  • Current alcohol or drug abuse, or psychological reasons that make study participation impractical
  • Drugs which are potential causal for gingival hyperplasia (Hydantoin, Nifedipine, Cyclosporin A, and other)

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Martin Luther-University Halle-Wittenberg

    Halle, 06097

Other trials in Germany

About this study

Official title: Periodontitis and Its Microbiological Agents as Prognostic Factors in Patients With Coronary Heart Disease

"Atherosclerosis is an inflammatory disease". The hypothesis of an infectious burden as trigger or initiator of the inflammatory process in atherosclerosis has been extensively discussed in the past years. One part of this discussion is focused on the infectious agents responsible for periodontitis. Several studies have found an association of periodontitis and/or bacteria related to this disease and atherosclerosis. However, a study focussing on the prognostic relevance of these factors is missing.

The hypothesis of this study is that periodontitis is a prognostic relevant risk factor for patients with angiographically proven coronary heart disease. Furthermore, the infectious pathogen burden by PCR-detection of periodontal pathogens will be evaluated as a prognostic factor.

Read more

960 consecutive patients with angiographically proven coronary heart disease will be included in this study. After inclusion of patients an extensive periodontal examination including PCR-sampling for 11 bacteria (Porphyromonas gingivitis, Actinobacillus actinomycetemcomitans, and others) will be performed. After 12 months patient will be follow up for any major adverse events (cardiovascular death, myocardial infarction, stroke).

If this study will find a relation of periodontitis or its microbiological agents to cardiovascular outcome of patients with coronary heart disease, further studies are necessary to investigate potential therapeutic consequences for patients with CHD and periodontitis.

Keywords
periodontitis and coronary heart disease
Medical subject headings
Periodontitis, Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01045070
Study groupRoleWhat they receive
coronary heart diseaseNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Combined endpoint: myocardial infarction, cardiovascular death, stroke

    Measured: 12 months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2010 (estimated)
  2. Study startOct 2009
  3. Primary completionDec 2010
  4. Study completionMay 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
960 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01045070
Sponsor's protocol ID
F/34/08
Status last verified
May 2012
First submitted
7 Jan 2010
Last updated
2 May 2012
Results posted
No
Data monitoring committee
No

Publications

  • Reichert S, Schlitt A, Rehm S, Schulz S. Impact of severe periodontitis and diabetes mellitus on recurrent cardiovascular outcomes. J Periodontol. 2026 Jun;97(6):1360-1371. doi: 10.1002/jper.70086. Epub 2026 Mar 6.

    PubMed 41789954

  • Reichert S, Rehm S, Schlitt A, Schulz S. Severe Periodontitis is Associated With Recurrent Cardiovascular Events-A 10-Year Longitudinal Cohort Study. J Periodontal Res. 2025 Dec;60(12):1201-1211. doi: 10.1111/jre.13365. Epub 2024 Nov 22.

    PubMed 39578376

  • Schulz S, Reuter L, Navarrete Santos A, Bitter K, Rehm S, Schlitt A, Reichert S. Major Adverse Cardiovascular Events: The Importance of Serum Levels and Haplotypes of the Anti-Inflammatory Cytokine Interleukin 10. Biomolecules. 2024 Aug 9;14(8):979. doi: 10.3390/biom14080979.

    PubMed 39199367

  • Schulz S, Rehm S, Schlitt A, Bitter K, Reichert S. The Interleukin 6 Protein Level as well as a Genetic Variants, (rs1800795, rs1800797) Are Associated with Adverse Cardiovascular Outcomes within 10-Years Follow-Up. Cells. 2023 Nov 28;12(23):2722. doi: 10.3390/cells12232722.

    PubMed 38067150

  • Schulz S, Rehm S, Schlitt A, Lierath M, Ludike H, Hofmann B, Bitter K, Reichert S. C-Reactive Protein Level and the Genetic Variant rs1130864 in the CRP Gene as Prognostic Factors for 10-Year Cardiovascular Outcome. Cells. 2023 Jul 4;12(13):1775. doi: 10.3390/cells12131775.

    PubMed 37443809

  • Schulz S, Zielske M, Schneider S, Hofmann B, Schaller HG, Schlitt A, Reichert S. Polymorphism of CD14 Gene Is Associated with Adverse Outcome among Patients Suffering from Cardiovascular Disease. Mediators Inflamm. 2021 Jul 8;2021:3002439. doi: 10.1155/2021/3002439. eCollection 2021.

    PubMed 34305452

  • Reichert S, Seitter L, Schaller HG, Schlitt A, Schulz S. ANRIL polymorphisms (rs1333049 and rs3217992) in relation to plasma CRP levels among in-patients with CHD. Cytokine. 2020 Mar;127:154932. doi: 10.1016/j.cyto.2019.154932. Epub 2019 Nov 27.

    PubMed 31770616

  • Schulz S, Schlitt A, Hofmann B, Schaller HG, Reichert S. Periodontal pathogens and their role in cardiovascular outcome. J Clin Periodontol. 2020 Feb;47(2):173-181. doi: 10.1111/jcpe.13224. Epub 2019 Dec 16.

    PubMed 31765020

  • Reichert S, Schlitt A, Benten AC, Hofmann B, Schaller HG, Schulz S. Data on IL-6 c.-174 G>C genotype and allele frequencies in patients with coronary heart disease in dependence of cardiovascular outcome. Data Brief. 2016 Jul 16;8:1295-9. doi: 10.1016/j.dib.2016.07.020. eCollection 2016 Sep.

    PubMed 27570807

  • Schulz S, Schlitt A, Lutze A, Lischewski S, Seifert T, Dudakliewa T, Gawe R, Werdan K, Hofmann B, Glaser C, Schaller HG, Reichert S. The importance of genetic variants in TNFalpha for periodontal disease in a cohort of coronary patients. J Clin Periodontol. 2012 Aug;39(8):699-706. doi: 10.1111/j.1600-051X.2012.01909.x. Epub 2012 Jun 12.

    PubMed 22691114

Questions about this trial

What is this clinical trial studying?

An observational study of Periodontitis and Coronary Heart Disease, run by Martin-Luther-Universität Halle-Wittenberg at 1 site in Germany.

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 2 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 2 May 2012. 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 Germany. 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?

Combined endpoint: myocardial infarction, cardiovascular death, stroke (time frame: 12 months follow-up). 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 NCT01045070, which also lists 10 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 2 May 2012.

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