Dental Prophylaxis and Rheumatoid Arthritis (PREPARA II)

Influence of Dental Prophylaxis on Disease Activity of Rheumatoid Arthritis

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.

Study Overview

• Status: Unknown
• Conditions: Rheumatoid Arthritis; Periodontitis; Gingivitis; Dental Prophylaxis
• Intervention / Treatment: Procedure: Dental Prophylaxis

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
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Heidelberg, Germany, 69120
    • Recruiting
    • University Hospital Heidelberg
    • Contact: Diana Wolff, Prof. Dr. med. dent.; Phone Number: +49 (0)6221-56-6589; Email: diana.wolff@med.uni-heidelberg.de
    • Contact: Kyrill Schoilew, Dr. med. dent.; Email: 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.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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
Other: 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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University Hospital Heidelberg
• Investigators: Principal Investigator: Diana Wolff, Prof. Dr. med. dent., University Hospital Heidelberg

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2017
• Primary Completion (Anticipated): August 1, 2019
• Study Completion (Anticipated): February 1, 2020

Study Registration Dates

• First Submitted: March 15, 2017
• First Submitted That Met QC Criteria: March 15, 2017
• First Posted (Actual): March 22, 2017

Study Record Updates

• Last Update Posted (Actual): May 8, 2017
• Last Update Submitted That Met QC Criteria: May 3, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Biofilm; Dental Scaling; Oral Health; Intestinal Microbiome; Oral Microbiome; Disease Activity Score 28 (DAS28); Health Assessment Questionnaire (HAQ); Dental Polishing; Gingival Crevicular Fluid; Inflammatory Cytokine Profile
• Additional Relevant MeSH Terms: Infections; Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Arthritis; Arthritis, Rheumatoid; Periodontitis; Gingivitis
• Other Study ID Numbers: S-130/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No