Prevalence and severity of periodontitis in patients with rheumatoid arthritis (RA) and the effects of treatment
Not Applicable
- Conditions
- Periodontitis and Rheumatoid ArthritisOral Health
- Registration Number
- ISRCTN16761141
- Lead Sponsor
- Karolinska Institutet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
1. = 18 years of age
2. Fulfilling the 2010 ACR criteria for RA
3. Moderate to severe periodontitis, defined according to the classification criteria of the CDC Working Group meant for usage in Population-Based Surveillance of Periodontitis
4. Written informed consent to participate
5. Swedish national registration number
Exclusion Criteria
1. Antibiotic treatment =3 months prior to inclusion into the study
2. Periodontal treatment (surgical or non-surgical) =3 months prior to inclusion into the study
3. Pregnancy
4. Simultaneous participation in other interventional studies
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Rheumatoid arthritis (RA) disease activity is measured using the DAS28 score, HAQ score at baseline and one year<br>2. Periodontal parameters (such as probing pocket depth, clinical attachment loss) are measured using the methods of measurement of periodontal disease/parameters at baseline and months three, six, nine, and twelve
- Secondary Outcome Measures
Name Time Method 1. The microbial profile is assessed using sequencing technology throughout the study (the specific time points depend on the availability of the resources as well as the instruments at core facility) <br>2. Antibody levels (such as ACPA/RF, periodontal pathogens etc) are measured using multiplex immunoassay, nephelometry and/or ELISA technique at baseline and one year<br>3. Levels of inflammatory mediators are measured using Luminex immunoassay at baseline and one year