Dental Prophylaxis and Rheumatoid Arthritis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Influence of Dental Prophylaxis on Disease Activity of Rheumatoid Arthritis

Conditions
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Rheumatoid Arthritis, Periodontitis, Gingivitis, Dental Prophylaxis

Intervention / Treatment
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* Procedure: Dental Prophylaxis


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test<br>Dental Prophylaxis at fist visit (T0), after 2 weeks (T1) and after 3 months (T2) | Procedure: Dental Prophylaxis<br>* Prevention and treatment of periodontal diseases by cleaning of the teeth in the dental office using the procedures of dental scaling and dental polishing. The treatment includes plaque detection, removal of supra- and subgingival plaque and calculus, as well as motivation and demonstration for establishing a sufficient oral hygiene.<br>* Other names: Dental Polishing;|
| Other: Control<br>Wait & Control Study Design: Dental Prophylaxis after 3 months (T2) only | Procedure: Dental Prophylaxis<br>* Prevention and treatment of periodontal diseases by cleaning of the teeth in the dental office using the procedures of dental scaling and dental polishing. The treatment includes plaque detection, removal of supra- and subgingival plaque and calculus, as well as motivation and demonstration for establishing a sufficient oral hygiene.<br>* Other names: Dental Polishing;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Activity Score 28 (DAS28) | The Disease Activity Score 28 (DAS28) combines single measures into an overall, continuous measure of Rheumatoid Arthritis disease activity. The DAS28 includes a 28 tender joint count, a 28 swollen joint count, acute phase reactant and a general health assessment on a visual analog scale. | baseline (T0) and three months (T2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Assessment Questionnaire (HAQ) | The Health Assessment Questionnaire (HAQ) is a comprehensive, validated, patient-oriented outcome assessment instrument. It includes the five dimensions disability, pain, medication effects, costs of care and mortality, which are then further subcategorized. | baseline (T0) and three months (T2) | 
| Microbiome and Inflammatory Cytokine Profile | The development of the bacterial microflora and inflammatory cytokine profile is being analyzed qualitatively and quantitatively by molecular genetic methods. Samples of supra- and subgingival plaque, gingival crevicular fluid and saliva are being collected at T0, T2 and T3, stool samples are being collected at T0 and T2. | baseline (T0), three months (T2) and six months (T3) | 
| Cumulative Steroid Dose | The cumulative steroid dose is being compared between Group 1 (Test) and Group 2 (Control). | baseline (T0), three months (T2) and six months (T3) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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