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Dental Prophylaxis and Rheumatoid Arthritis (PREPARA II)

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ClinicalTrials.gov Identifier: NCT03087240
Recruitment Status : Recruiting
First Posted : March 22, 2017
Last Update Posted : May 8, 2017
Sponsor:
Information provided by (Responsible Party):
Diana Wolff, University Hospital Heidelberg

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Periodontitis Gingivitis Dental Prophylaxis Procedure: Dental Prophylaxis Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Influence of Dental Prophylaxis on Disease Activity of Rheumatoid Arthritis
Actual Study Start Date : February 28, 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Test
Dental Prophylaxis at fist visit (T0), after 2 weeks (T1) and after 3 months (T2)
Procedure: Dental Prophylaxis
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.
Other Names:
  • Professional Teeth Cleaning
  • Dental Scaling
  • Dental Polishing

Control
Wait & Control Study Design: Dental Prophylaxis after 3 months (T2) only
Procedure: Dental Prophylaxis
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.
Other Names:
  • Professional Teeth Cleaning
  • Dental Scaling
  • Dental Polishing




Primary Outcome Measures :
  1. Disease Activity Score 28 (DAS28) [ Time Frame: baseline (T0) and three months (T2) ]
    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.


Secondary Outcome Measures :
  1. Health Assessment Questionnaire (HAQ) [ Time Frame: baseline (T0) and three months (T2) ]
    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.

  2. Microbiome and Inflammatory Cytokine Profile [ Time Frame: baseline (T0), three months (T2) and six months (T3) ]
    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.

  3. Cumulative Steroid Dose [ Time Frame: baseline (T0), three months (T2) and six months (T3) ]
    The cumulative steroid dose is being compared between Group 1 (Test) and Group 2 (Control).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03087240


Contacts
Contact: Diana Wolff, Prof. Dr. med. dent. +49 (0)6221-56-6589 diana.wolff@med.uni-heidelberg.de
Contact: Kyrill Schoilew, Dr. med. dent. kyrill.schoilew@med.uni-heidelberg.de

Locations
Germany
University Hospital Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Diana Wolff, Prof. Dr. med. dent.    +49 (0)6221-56-6589    diana.wolff@med.uni-heidelberg.de   
Contact: Kyrill Schoilew, Dr. med. dent.       kyrill.schoilew@med.uni-heidelberg.de   
Principal Investigator: Diana Wolff, Prof. Dr. med. dent.         
Sub-Investigator: Björn Wolff, Dr. rer. nat.         
Sub-Investigator: Anna Felten, Dr. med. dent.         
Sub-Investigator: Niko Bender, Dr. med.         
Sub-Investigator: Kyrill Schoilew, Dr. med. dent.         
Sponsors and Collaborators
University Hospital Heidelberg
Investigators
Principal Investigator: Diana Wolff, Prof. Dr. med. dent. University Hospital Heidelberg

Publications:
Responsible Party: Diana Wolff, Deputy Medical Director, Department of Conservative Dentistry, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT03087240     History of Changes
Other Study ID Numbers: S-130/2016
First Posted: March 22, 2017    Key Record Dates
Last Update Posted: May 8, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Diana Wolff, University Hospital Heidelberg:
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

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Gingival Diseases
Arthritis
Arthritis, Rheumatoid
Periodontitis
Gingivitis