To assess periodontitis-with P. gingivalis in particular- as a pathogenic factor in disease progression of RA.
ID
Source
Brief title
Condition
- Allergic conditions
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Disease Activity Score 28 joint count (DAS28)
Secondary outcome
Periodontal Inflamed Surface Area (PISA)
ACPA titer
Leucocyte count, CRP and ESR.
Presence of P. gingivalis in microbial plaque
Background summary
Periodontitis, with Porphyromonas gingivalis in particular, is considered to be
of influence on disease progression of rheumatoid arthritis (RA), by
inflammatory burden posed by this microbial challenge and protein
citrullination by P. gingivalis. If there is a distinct relation between these
two diseases, treatment of periodontitis would be of influence on RA disease
progression.
Study objective
To assess periodontitis-with P. gingivalis in particular- as a pathogenic
factor in disease progression of RA.
Study design
A cross-over clinical trial on periodontal therapy of RA patients with
generalized severe periodontitis, analysing clinical parameters and biomarkers
of both diseases. The intervention will be non-surgical periodontal treatment
and antimicrobial therapy.
Intervention
Non-surgical periodontal treatment and systemic antimicrobials.
Study burden and risks
There are no risks associated with participation. The potential benefit to
participants will be treatment of periodontitis.
Antonius Deusinglaan 1
9713AV
NL
Antonius Deusinglaan 1
9713AV
NL
Listed location countries
Age
Inclusion criteria
RA patients
1. Fulfilling the American College of Rheumatology classification criteria for RA (1987)
2. Age > 18 years
3. Fulfilling the classification criteria of periodontal diseases for generalized severe chronic periodontitis according
to the 1999 International Workshop for Classification of Periodontal Diseases and Conditions
Exclusion criteria
1. Infection or inflammation other than periodontitis or RA
2 Present malignancy
3. Other conditions which influence the immune system:, diabetes, active thyroid disease, myocardial infarction,
stroke or recanalisation of the femoral arteries for claudication <6 months prior to the study
4. Pregnancy including a 6-months post-partem period as well as breastfeeding
5. Malnutrition
6. Alcoholism and drug abuse
7. Pharmacological interference: use of corticosteroids >10mg/dag, antibiotic use during 3 months prior to the
study, allergy to amoxicillin or metronidazole
8. Edentulism
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 | NL36030.042.11 |