The aim of the research is to enroll 100 consecutive untreated periodontitis patients for the normal standard treatment. We will investigate by means of venous blood analyses before treatment and 3, 6, and 12 months after treatement whether plasma…
ID
Source
Brief title
Condition
- Myocardial disorders
- Glucose metabolism disorders (incl diabetes mellitus)
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Probing pocket depth, bleeding on probing, change in attachment level, plasma
levels of CRP, PAI-1, fibrinogen, von Willebrand factor (vWF), Leucocytes,
Vitamin C, Insulin and Glucose.
Secondary outcome
Proteomes of saliva and serum
Background summary
Periodontitis is a destructive inflammation of the supporting tissues
(periodontium) of the teeth. Periodontitis is considered a multifactorial
infection. Several of the different species of bacteria form the subgingival
plaque that can be isolated seem to be strongly associated with periodontitis.
It is also important to mention the role played by genetic factors in the
etiopathogenesis of the periodontitis. Periodontitis has the tendency to be
familiar and there are some gnetic polymorphisms that are associated with the
severity of the disease. Besides, lifestyle factors play also an important
role. It seems that smoking is the most important, but iet seems to play an
important role too. Recent researches show that probably Vitamin C is important.
Because of the complex pathogenesis of periodontitis, the understanding about
the interaction between the periodontium and the etiologic factors is limited.
In this respect, the knowledge of proteomics can be helpful.
Epidemiological researches show that there is a possible relationship between
periodontitis and the pathogenesis of cardiovascular diseases (CVD) and
metabolic syndrome (MS). Different proteins as C-Reactive Protein (CRP),
Plasminogen Activator Inhibitor-1 (PAI-1), fibrinogen and von Willebrand Factor
(vWF), which can play a role in the prevalence of CVD/MS, are also elevated in
periodontitis patients. Recently there are studies published that show that a
standard periodontal treatment (scaling, root planning and oral hygiene
instructions) in otherwise healthy patients give a reductions in plasma levels
of CRP.
At the light of the geographic differences in the prevalence of CVD/MS and
periodontitis, as well in dietary habits, education and social class, it is
essential to confirm also in the Netherlands that a normal periodontal
treatment van lead to a reduction of biomarkers of CVD/MS in otherwise healthy
people
Study objective
The aim of the research is to enroll 100 consecutive untreated periodontitis
patients for the normal standard treatment. We will investigate by means of
venous blood analyses before treatment and 3, 6, and 12 months after treatement
whether plasma levels of biomarkers related to CVD/MS are reduced after
treatment. Levels of these biomarkers will be related also to the microbial
composition of the infection and the genetic polymorphisms and lifestyle
factors.
Study design
De totale tijdsduur voor de patiënt bij de eerste afspraak is 1,5 uur.
Vervolgens zullen punten 2 t/m 5 herhaald worden tijdens de normale bezoeken op
3, 6 en 12 maanden na het afronding van de behandeling (4ma, 7ma en 13ma).
Klinische metingen worden standaard uitgevoerd op deze bezoeken en zullen
t.b.v. het onderzoek overgenomen worden uit het dossier van de patiënt.
Van iedere patient zal -gecodeerd- plasma, serum en DNA worden opgeslagen voor
het onderzoek.
For this project we will submit the first 100 new periodontitis patients that
are accepted for treatment at ACTA to a standardized research protocol
(unselected cohort).
Every patient will undergo the following:
1) Introduction, explanation of the aim of the research, signing of the inform
consent (5 min).
2) General health anamnesis (inclusive blood pressure, weight, length, waist
circumference and recording of smoking habits)(15 min).
3) Blood sample (10 min).
4) Unstimulated saliva sample (5 min).
5) Selection of the sites for bacterial sample (4) - the deepest pocket per
quadrant and subsequently subgingival bacterial sampling. (15 min).
6) Standard periodontal clinical measurements (bleeding index, probing pocket
depth and clinical attachment level)(50 min).
The total time needed at the first appointment will be of 1,5 hour. The points
2-5 will be repeated during the normal maintenance appointments 3, 6 and 12
months after the accomplishment of the treatment. The periodontal clinical
measurements will be carried out during the maintenance visits. They will be
consulted in the patient chart on behalf of the research.
Coded plasma, Serum, DNA of every patient will be saved for the research.
Intervention
Standard periodontal treatment (oral hygiene instructions, mechanical scaling
and root planing)
Study burden and risks
No other risks than the standard periodontal treatment and the venepuncture.
Louwesweg 1
1066 EA, Amsterdam
Nederland
Louwesweg 1
1066 EA, Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
The patients must show on dental radiograph periodontal bone loss of > 1/3 of the total length of the root on > 1 tooth per quadrant.
Exclusion criteria
1) No pregnancy.
2) No chronic diseases with exception of periodontitis and no acute diseases or infections in the last 4 weeks.
3) No chronic medications
4) No chronic medications that can have an effect on the periodontal tissues (e.g. antibiotics) in the past 6 months and no anti-inflammatory drugs (NSAID's) in the past 4 weeks.
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 | NL15199.018.07 |