|- candidate number||27192|
|- NTR Number||NTR6362|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-mei-2017|
|- Secondary IDs||NL61521.048.17 CCMO|
|- Public Title||De wisselwerking tussen reumato´de artritis en de weefsels in en rond de mond.|
|- Scientific Title||The interaction between arthritis and the orofacial tissues ľ prediction and prevention of rheumatoid arthritis.|
|- hypothesis||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.|
|- Healt Condition(s) or Problem(s) studied||Rheumatoid arthritis, Periodontitis|
|- Inclusion criteria||- 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
|- Exclusion criteria||- ACTA dental students|
- Employees from ACTA or Reade
Additional Exclusion criteria group 3 (control group):
- General health: no autoimmune conditions
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-jun-2017|
|- planned closingdate||1-jun-2022|
|- Target number of participants||175|
|- Interventions||This is an observational study, no intervention takes place.|
|- Primary outcome||- Temporomandibular Joint Dysfunction diagnosed according to the DC/TMD criteria, additional static muscle tests and dynamic joint tests on the temporomandibular joint.|
- Presence or absence of serological precursors of rheumatoid arthritis: IgM-RF and ACPA serum levels.
|- Secondary outcome||- Microbiological composition: saliva, tongue coating and dental plaque composition.|
- Quantity of fluorescent dental plaque in relation to nutrition: taking fluorescence photographs of the teeth using a dedicated fluorescence camera and filling in a food questionnaire during two days prior to the first research visit.
- Periodontal health: level of bleeding on probing, gingival recessions (positive and negative), dental pocket depth (in mm) and presence / absence of dental plaque, all measured on six sites for each tooth.
- Immuno-biochemical characteristics: gingival crevicular fluid.
- Oral health: amount of decayed, missing and filled teeth, and mucosal lesions.
- General health: standardized health questionnaire, with additional questions about recent use of antibiotics and pain killers.
- Oral Health Impact Profile: short validated OHIP 4 questionnaire.
- Patient reported outcomes of physical function, pain and global status: RAPID questionnaire.
|- Timepoints||- Temporomandibular Joint Dysfunction: baseline, 6 months, 3 years.|
- Serological precursors for rheumatoid arthritis: baseline.
- Microbiological composition: baseline, 6 months, 3 years. 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 after baseline will be added for the microbiological composition.
- Quantity of fluorescent dental plaque in relation to nutrition: baseline.
- Periodontal health: baseline.
- Immuno-biochemical characteristics: baseline.
- Oral health: baseline.
- General health: baseline, 6 months, 3 years.
- Oral Health Impact Profile: baseline, 6 months, 3 years.
- Patient reported outcomes of physical function, pain and global status: baseline, 6 months, 3 years.
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| J.M. Kroese |
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. Frank Lobbezoo|
|- Sponsor/Initiator ||Academic Center Dentistry Amsterdam (ACTA)|
(Source(s) of Monetary or Material Support)
|Academic Center Dentistry Amsterdam (ACTA)|
|- Brief summary||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 and 3 years after baseline, this study will focus on the development of temporomandibular joint dysfunction and the oral microbiome within the three groups. 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. |
|- Main changes (audit trail)|
|- RECORD||11-mei-2017 - 16-jun-2017|