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Dental Prophylaxis and Rheumatoid Arthritis

Influence of Dental Prophylaxis on Disease Activity of Rheumatoid Arthritis

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03087240
Acronym
PREPARA II
Enrollment
70
Registered
2017-03-22
Start date
2017-02-28
Completion date
2020-02-29
Last updated
2017-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

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.

Sponsors

University Hospital Heidelberg
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Disease Activity Score 28 (DAS28)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

MeasureTime frameDescription
Health Assessment Questionnaire (HAQ)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.
Microbiome and Inflammatory Cytokine Profilebaseline (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.
Cumulative Steroid Dosebaseline (T0), three months (T2) and six months (T3)The cumulative steroid dose is being compared between Group 1 (Test) and Group 2 (Control).

Countries

Germany

Contacts

Primary ContactDiana Wolff, Prof. Dr. med. dent.
diana.wolff@med.uni-heidelberg.de+49 (0)6221-56-6589
Backup ContactKyrill Schoilew, Dr. med. dent.
kyrill.schoilew@med.uni-heidelberg.de

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026