Clinical trial NCT03087240: Dental Prophylaxis and Rheumatoid Arthritis
Official title: Influence of Dental Prophylaxis on Disease Activity of Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rheumatoid Arthritis
Periodontitis
Gingivitis
Dental Prophylaxis
Keywords: Disease Activity Score 28 (DAS28)
Health Assessment Questionnaire (HAQ)
Dental Scaling
Dental Polishing
Oral Health
Gingival Crevicular Fluid
Inflammatory Cytokine Profile
Biofilm
Oral Microbiome
Intestinal Microbiome
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2017-03-22
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study evaluates the influence of dental prophylaxis on disease activity of Rheumatoid Arthritis. In addition to standard antirheumatic therapy, recently the question has been raised whether or not there is a supplementary beneficial effect due to professional teeth cleaning. So far just a few studies pursued this question, indicating that prophylaxis by dental professionals can alleviate the symptoms of Rheumatoid Arthritis. To further evaluate this question, in our study half of the participants will receive dental prophylaxis at their first visit, after 2 weeks and 3 months, while the other half will receive professional teeth cleaning after 3 months only.

Detailed description: Periodontitis (PA) and Rheumatoid Arthritis (RA) both rely on an over-regulated immune response, leading to inflammation in joints and periodontium. It is known, that both diseases have a reciprocal influence and that therapy of one disease may have beneficial effects on the course of the other.

This study evaluates the influence of dental prophylaxis on disease activity of Rheumatoid Arthritis, in addition to standard antirheumatic therapy. Patients are being recruited from the Department of Rheumatology at the Heidelberg University Hospital. Patients being diagnosed with an active Rheumatoid Arthritis (DAS28-Score \> 3.2) will be included into the current study.

The study follows a prospective, randomized, controlled study design with the participating dental and rheumatologic investigators being both blinded. The first visit (T0) includes the assessment of demographic and disease-related parameters, such as quality of life (HAQ - Health Assessment Questionnaire) and disease activity (DAS28 - Disease Activity Score 28) by a rheumatologist. Afterwards a dental investigator will determine the status of oral health with standard parameters (periodontal status (pocket depth, attachment level, Bleeding on Probing (BPI)) and dental status (DMFT - Decayed Missing Filled Teeth)). Subsequently patients are being randomized 1:1. The dental intervention is defined as a standardized dental prophylaxis according to the Heidelberg Therapeutic Scheme for Hygienization of the Oral Condition by means of professional teeth cleaning and motivational and demonstrational measures for implementing a sufficient oral hygiene.

Group 1 (Test) contains patients being randomized for the dental intervention at first visit. Accordingly Group 2 (Control) contains patients not being randomized for the dental intervention. After 14 days (T1) patients in Group 1 undergo once again dental prophylaxis according the Heidelberg Therapeutic Scheme. The next follow-up is being executed after 3 months (T2) by rheumatologic and dental investigators again. The primary outcome consists of the evaluation of the disease activity of the Rheumatoid Arthritis measured by the DAS28-Score between first visit (T0) and after 3 months (T2). Patients of Group 2 receive dental prophylaxis after 3 months due to ethical reasons ("Wait \& Control Study Design"). The final visit takes place after an additional 3 months (T3), in order to evaluate a possible long-term effect of the dental intervention.

Furthermore the development of the bacterial microflora and inflammatory cytokine profile is being investigated. For this purpose, samples of supra- and subgingival plaque, gingival crevicular fluid and saliva at visits T0, T2 and T3 as well as stool samples at T0 and T2 are being collected. These will be analyzed qualitatively and quantitatively by molecular genetic methods.

Eligibility criteria: Inclusion Criteria:

* Signed consent form
* Diagnosis of an active Rheumatoid Arthritis (DAS28 \> 3.2) by a rheumatologist
* Gingiva Bleeding Index (GBI) \> 10%, Plaque Control Record (PCR) \> 30% (indication for Dental Prophylaxis following the Heidelberg Therapeutic Scheme)

Exclusion Criteria:

* Generalized Severe Chronic Periodontitis
* Periodontal treatment within the last 6 months
* Dental Prophylaxis within the last 6 months
* Dental Prophylaxis being contraindicated due to dental or other reasons
* Antibiotic treatment within the last 3 months (excluding intake of antibiotic prophylaxis)

Primary outcomes:
measure: Disease Activity Score 28 (DAS28)
timeFrame: baseline (T0) and three months (T2)
Secondary outcomes:
measure: Health Assessment Questionnaire (HAQ)
timeFrame: baseline (T0) and three months (T2)
measure: Microbiome and Inflammatory Cytokine Profile
timeFrame: baseline (T0), three months (T2) and six months (T3)
measure: Cumulative Steroid Dose
timeFrame: baseline (T0), three months (T2) and six months (T3)
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg
Study officials:
affiliation: University Hospital Heidelberg
name: Diana Wolff, Prof. Dr. med. dent.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Janssen KM, Vissink A, de Smit MJ, Westra J, Brouwer E. Lessons to be learned from periodontitis. Curr Opin Rheumatol. 2013 Mar;25(2):241-7. doi: 10.1097/BOR.0b013e32835d833d.
citation: Ortiz P, Bissada NF, Palomo L, Han YW, Al-Zahrani MS, Panneerselvam A, Askari A. Periodontal therapy reduces the severity of active rheumatoid arthritis in patients treated with or without tumor necrosis factor inhibitors. J Periodontol. 2009 Apr;80(4):535-40. doi: 10.1902/jop.2009.080447.