Dental Prophylaxis and Rheumatoid Arthritis

NCT ID: NCT03087240

Last Updated: 2017-05-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-28
• Study Completion Date: 2020-02-29

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.

Conditions

Rheumatoid Arthritis; Periodontitis; Gingivitis; Dental Prophylaxis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Test

Dental Prophylaxis at fist visit (T0), after 2 weeks (T1) and after 3 months (T2)

Group Type: EXPERIMENTAL

Dental Prophylaxis

Intervention Type: PROCEDURE

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.

Control

Wait \& Control Study Design: Dental Prophylaxis after 3 months (T2) only

Group Type: OTHER

Dental Prophylaxis

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

Professional Teeth Cleaning; Dental Scaling; Dental Polishing

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Heidelberg

OTHER

Sponsor Role: lead

Responsible Party

Diana Wolff

Deputy Medical Director, Department of Conservative Dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Diana Wolff, Prof. Dr. med. dent.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Heidelberg

Locations

University Hospital Heidelberg

Heidelberg, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Diana Wolff, Prof. Dr. med. dent.

Role: CONTACT

diana.wolff@med.uni-heidelberg.de

+49 (0)6221-56-6589

Kyrill Schoilew, Dr. med. dent.

Role: CONTACT

kyrill.schoilew@med.uni-heidelberg.de

Facility Contacts

Diana Wolff, Prof. Dr. med. dent.

Role: primary

diana.wolff@med.uni-heidelberg.de

+49 (0)6221-56-6589

Kyrill Schoilew, Dr. med. dent.

Role: backup

kyrill.schoilew@med.uni-heidelberg.de

References

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.

Reference Type: BACKGROUND

PMID: 23370377 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19335072 (View on PubMed)

Other Identifiers

S-130/2016

Identifier Type: -

Identifier Source: org_study_id