The aim of this research is to compare patients with early rheumatoid arthritis and patients with an increased risk of developing this disease to a control group with no auto-immune conditions on the prevalence of diseases of the orofacial tissues.…
ID
Bron
Verkorte titel
Aandoening
Rheumatoid arthritis, temporomandibular joint dysfunction, periodontitis.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
- Temporomandibular Joint Dysfunction diagnosed according to the DC/TMD criteria, additional static muscle tests and dynamic joint tests on the temporomandibular joint.<br>
- Presence or absence of serological precursors of rheumatoid arthritis: IgM-RF and ACPA serum levels.<br>
Achtergrond van het onderzoek
The overall subject of this project is the interaction between rheumatoid arthritis and the orofacial tissues, being explored in a multicenter, observational prospective cohort study. In this study three groups will be compared: (1) patients with an early stage of rheumatoid arthritis, (2) patients with an increased risk of developing this disease, and (3) a control group with no auto-immune conditions. The groups will be compared on several intra- and extra-oral aspects: the temporomandibular joint, the presence and composition of dental plaque, bacteria in saliva and on the tongue, and periodontal condition. At baseline, possible differences in the oral microbiome and prevalence of diseases of the orofacial tissues will be studied. Over time, at 6 months, 1 year, 2 years and 3 years after baseline, this study will focus on the general health of subjects, with specific interest in the possible development of RA in group 2 and the RA disease status of patients in group 3.
All patients will be recruited in the Netherlands, with groups 1 and 2 being recruited at Reade (a center for revalidation and rheumatology in Amsterdam), and group 3 at the Academic Centre for Dentistry Amsterdam.
Doel van het onderzoek
The aim of this research is to compare patients with early rheumatoid arthritis and patients with an increased risk of developing this disease to a control group with no auto-immune conditions on the prevalence of diseases of the orofacial tissues. Participants will be compared on several intra-oral and extra-oral aspects: the temporomandibular joint, the presence and composition of dental plaque, bacteria in saliva and on the tongue, and periodontal condition. New insights gained from this research might be useful during monitoring and treatment of patients with (an increased risk of developing) rheumatoid arthritis.
Onderzoeksopzet
- Temporomandibular Joint Dysfunction: baseline.
- Serological precursors for rheumatoid arthritis: baseline.
- Microbiological composition: baseline. Within group 2 (patients with an increased risk of developing RA), a subgroup will be recognized, consisting of patients taking part in an already ongoing study (NL47550.048.13) on the effects of statins on the development of RA. In these patients, an extra timepoint at 3 months and 6 months after baseline will be added for the microbiological composition.
- Quantity of fluorescent dental plaque in relation to nutrition: baseline.
- Periodontal health: baseline (and a short evaluation of periodontal health at 3 months and 6 months for the subgroup in group 2).
- Immuno-biochemical characteristics: baseline.
- Oral health: baseline.
- General health: baseline, 6 months, 1 year, 2 years, 3 years.
- Oral Health Impact Profile: baseline.
- Patient reported outcomes of physical function, pain and global status: baseline
Onderzoeksproduct en/of interventie
This is an observational study, no intervention takes place.
Publiek
J.M. Kroese
Gustav Mahlerlaan 3004
Amsterdam 1081 LA
The Netherlands
xxx
j.m.kroese@acta.nl
Wetenschappelijk
J.M. Kroese
Gustav Mahlerlaan 3004
Amsterdam 1081 LA
The Netherlands
xxx
j.m.kroese@acta.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Adult, ≥ 18 years
- A minimum of 12 natural teeth present in the mouth
- Willing and able to give written informed consent in the Dutch language
Additional inclusion criteria group 1 (rheumatoid arthritis patients):
- Diagnosis of RA according to the treating rheumatologist: increased serum levels
of IgM-RF or ACPA combined with 2 swollen joints or serum levels of both IgMRF
and ACPA combined with 1 swollen joint within the last year.
Additional inclusion criteria group 2 (individuals at increased risk of RA):
- Increased serum levels of IgM-RF or ACPA
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- ACTA dental students
- Employees from ACTA or Reade
Additional Exclusion criteria group 3 (control group):
- General health: no autoimmune conditions
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL6198 |
NTR-old | NTR6362 |
CCMO | NL61521.048.17 |
OMON | NL-OMON47476 |