The main objective of this study is to investigate whether a long lasting pro-inflammatory phenotype, the characteristic of trained immunity, is present in circulating monocytes of patients with severe periodontal disease and whether this correlates…
ID
Source
Brief title
Condition
- Other condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Health condition
parodontitis
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter will be to correlate tissue inflammation, measured by
TBR max with 18F-FDG on PET-CT scanning of periodontal tissue with the vascular
wall, spleen and bone marrow in patients with versus without periodontal
disease.
Secondary outcome
The cytokine/chemokine response to ex vivo stimulation of the innate immune
cells in patients with versus without periodontal disease.
Background summary
Over 25 years of accumulating evidence shows that there is an association
between periodontal disease and cardiovascular disease. In 2012, the American
Heart Association stated that periodontitis (PD) is considered as an
independent risk factor for cardiovascular disease (CVD). The relationship
between PD and CVD is potentially of great public health importance due to the
high prevalence and economic burden of both diseases. For example, each year
17.5 million people die of cardiovascular diseases, and the prevalence of
moderate to severe periodontitis is as high as 40% worldwide.
However, the exact mechanistic link between periodontal disease and
cardiovascular disease remains unresolved. Several possible mechanisms have
been proposed to explain this association, however a comprehensive
understanding has not yet been developed. To our knowledge, both periodontitis
and atherosclerosis are chronic low grade inflammatory diseases involving a
close interaction with the innate immune system. In this research proposal we
hypothesize a new mechanism involving the innate immune system which might
elucidate the bilateral associations between cardiovascular disease and
periodontal disease. This study investigates the role of infection and
inflammation in atherosclerosis which might unravel new therapeutic options for
patients with periodontitis in the near future and gain new insight in the
understanding of atherosclerosis.
Study objective
The main objective of this study is to investigate whether a long lasting
pro-inflammatory phenotype, the characteristic of trained immunity, is present
in circulating monocytes of patients with severe periodontal disease and
whether this correlates with vascular wall inflammation and bone marrow
activity.
Study design
A prospective observational study.
Study burden and risks
In our opinion the risk of participation in this study is very low.
Participants will receive vene puncture and PET-CT scanning. Both procedures
are part of standardized medical care and considered safe. Vene puncture is
known for minor self-limiting side-effects, namely a hematoma. PET imaging with
low-dose-CT may reveal unanticipated pathology, and exposes the patients to
radioactivity (4.8 mSv) which is below the yearly radiation threshold. Infusion
of 18F-FDG can rarely result in treatable side-effects such as an allergic
reaction. See the SPC and study protocol for detailed information.
Geert Grooteplein-Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein-Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
- Age between 40 and 80 years
- With or without severe periodontitis with DPSI score of 0-2 resp. 4
- Written informed consent
Exclusion criteria
- Cardiovascular events
- Diabetes mellitus
- Chronic infections other than periodontitis
- Medical history of any disease associated with immune deficiency (either congenital or acquired, including chemotherapy, chronic steroid use, organ transplant)
- Fever (T > 38.5) or antibiotics use for infectious disease within 1 month prior study entry
- Chronic use of anti-inflammatory drugs such as NSAIDs
- Recent hospital admission or surgery with general anaesthesia (< 3 months)
- Known heart failure, chronic kidney (MDRD <45 ml/min) or liver disease (ALAT more than three times upper reference limit or known liver disease)
- Inability to personally provide written informed consent (e.g. for linguistic or mental reasons)
- Inability to undergo PET-CT scanning, including pregnancy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | clinicaltrails.gov registratienummer volgt |
| CCMO | NL61840.091.17 |