To evaluate wheter patients with parodontitis have a more procoagulant, proinflammatory and metabolically disturbed state than patients with a lower periodontal disease burden. Additionally, we want to explore how this relationship is modified by…
ID
Source
Brief title
Condition
- Other condition
- Coronary artery disorders
- Embolism and thrombosis
Synonym
Health condition
parodontitis
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Crossectional analysis: difference in coagulation, inflammation and metabolic
markers throughout the whole cohort, with PISA as an independent variable
Longitudinal analysis: difference in coagulation, inflammation and metabolic
markers of patients before and after undergoing a total tooth extraction
Secondary outcome
Exploratory analysis of the influence of oral mircobiome on the relationships
between PISA and primary outcome measures. Our focus will lie in evaluating the
quantitative presence of *red complex* bacteria (see Rationale), total
bacterial burden and its relationship with PISA and inflammatory/hemostatic
status. The goal is to generate hypotheses for further research.
Background summary
There is growing evidence that a broad range of inflammatory processes are risk
factors for both arterial and venous thrombotic events. Periodontitis is a
chronic inflammatory process of the gums which arises in response to the
accumulation of bacteria in a biofilm on tooth surfaces (dental plaque).
Periodontitis is known to be associated with intermittent bacteraemia
originating from oral microbiota and systemic inflammation, e.g. increased CRP
levels. Periodontitis has been associated with an increased risk of
cardiovascular disease. Although never previously studied, we hypothesize that
periodontitis, quantified through the Periodontal Inflammatory Surface Area
(PISA) is a risk factor for venous thrombotic events as well. More
specifically, we hypothesize that an increasing severity of periodontitis is
associated with an increasingly hypercoagulable, proinflammatory and disturbed
metabolic state that may predispose to acute thrombotic events.
Study objective
To evaluate wheter patients with parodontitis have a more procoagulant,
proinflammatory and metabolically disturbed state than patients with a lower
periodontal disease burden. Additionally, we want to explore how this
relationship is modified by oral microbiota
Study design
This study has a combined crossectional and longitudinal design:
PIRATE A: cross-sectional study: serum markers for coagulation, inflammation
and metabolism parameters, AGEs and oral microbiota of patients referred for
extraction of all teeth will be compared to the same measurements randomly
selected volunteers. In this analysis, PISA is the main independent variable,
and not case vs volunteer.
PIRATE B: cohort study, serum markers for coagulation, inflammation and
metabolism parameters and oral microbiota of patients with severe periodontitis
will be compared before and after extraction of all teeth, when the PISA is
reduced to zero.
Study burden and risks
Patients will be asked questions in relationship to their general health and
social-economic status. They will undergo venous blood sampling three times.
Before their procedure, a scraping of tongue, and an oral lavage will be
collected. For patients undergoing the procedure in general anaesthesia,
periodontal status will be acquired during general anaesthesia, just before the
surgeon performs the total tooth extraction. Time under general anesthesia will
be prolonged for 30 minutes to ascertain PISA measurements and for sampling of
Gingival plaque. A final visit ill be required at least 12 weeks after the
procedure. At this visit a scraping of tongue, a oral lavage and venous blood
will be collected. For measurements of lipids and glucose, they will be
requested to fast for this visit. volunteers will be asked to fast for their
visit to the UMCG. They wil be asked questions related to their general health
and social-economic status. They will undergo venous blood sampling once, after
which measurements of PISA will be done. Finally, samples of gingival plaque,
tong scrapings and a oral lavage will be collected.
Hanzeplein 1
Groningen 9700RB
NL
Hanzeplein 1
Groningen 9700RB
NL
Listed location countries
Age
Inclusion criteria
all participants are 18 years or older
cases need an indication to undergo a total tooth extraction. Indication has been made by an oral and maxillofacial surgeon
controls: age, smoking- and educational status matched volunteers who respond to poster advertisements
Exclusion criteria
inability to understand verbal and written Dutch or English language
participants with (end-stage) liver disease (Child Pugh Class A, B and C)
history of chronic auto immune disease (i.e. RA, vasculitis, IBD)
use of antiplatelet or antithrombotic medications
history of radiation in the head/neck region
patients referred for focus detection in order to receive chemotherapy and/or radiotherapy for the treatment of cancer
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 |
---|---|
CCMO | NL49846.042.14 |