1. The primary aim of the study is to investigate whether periodontal treatment results in a decrease of plasma biomarkers that are related to cardiovascular diseases (CVD) and metabolic syndrome (MS) and what is the effect of the treatment on theā¦
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, level of
subgingival bacterial recolonisation, 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
1. The primary aim of the study is to investigate whether periodontal treatment
results in a decrease of plasma biomarkers that are related to cardiovascular
diseases (CVD) and metabolic syndrome (MS) and what is the effect of the
treatment on the proteomic profile in serum.
2. The secundary aim is to investigate which of the following treatment
modalities shows the best clinical results and which is the most effective in
the reduction of plasma biomarkers related to CVD and MS, and which is the
different effect on the proteomic profile:
- SRP (standard periodontal treatment)
- SRP and antibiotics (amoxycillin + metronidazole)
- SRP and subgingival disinfection with 0.5 % NaOCl
- SRP and both antibiotics (amoxycillin + metronidazole) and subgingival
disinfection with 0.5 % NaOCl
3. Which of the following variables has a possible influence on the results of
the investigation:
- the composition of the subgingival plaque
- Genetic polymorphism for the markers investigated
- lifestyle related factors as smoking and vitamin C
Study design
For this project we will submit the first 200 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 patients will be randomly assigned to 4 groups, according to 4 different
modalities of treatment:
Group A: periodontal treatment (SRP)
Group B: SRP with support of antibiotics
Group C: SRP with support of NaOCl
Group D: SRP with support of antibiotics and NaOCl
2 extra appointments (1 week en 2 weeks after treatment) will be taken for
subgingival bacterial sample.
Coded plasma, Serum, DNA of every patient will be saved for the research.
Intervention
The patients will be randomly assigned to 4 groups, according to 4 different
modalities of treatment:
Group A: periodontal treatment (SRP)
Group B: SRP with support of antibiotics (amoxycillin 375 mg, 3 per day x 7
days + metronidazole 250 mg, 3 per day x 7 days)
Group C: SRP with support of NaOCl (local pocket rinsing)
Group D: SRP with support of antibiotics (amoxycillin 375 mg, 3 per day x 7
days + metronidazole 250 mg, 3 per day x 7 days) and NaOCl (local pocket
rinsing)
Study burden and risks
No other risks than the periodontal treatment and the venepuncture.
Louwesweg 1
1066 EA, Amsterdam
NL
Louwesweg 1
1066 EA, Amsterdam
NL
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 chronic diseases as CVD or diabetis with exception of periodontitis
2) No acute diseases or infections in the last 4 weeks.
3) No pregnancy.
4) No chronic medications
5) 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.
6) No hypersensitivity or controindication for the use of amoxycillin and/or metronidazol
Design
Recruitment
Medical products/devices used
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 |
---|---|
EudraCT | EUCTR2007-004405-95-NL |
CCMO | NL19679.018.07 |