Dental Prophylaxis and Rheumatoid Arthritis

NCT03087240 | Unknown

• 1 other identifier: S-130/2016
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Health Assessment Questionnaire (HAQ)

  baseline (T0) and three months (T2)

• Microbiome and Inflammatory Cytokine Profile

  baseline (T0), three months (T2) and six months (T3)

• Cumulative Steroid Dose

  baseline (T0), three months (T2) and six months (T3)

Study Arms (2)

Test

EXPERIMENTAL

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

Procedure: Dental Prophylaxis

Control

OTHER

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

Procedure: Dental Prophylaxis

Interventions

Dental Prophylaxis 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.

Also known as: Professional Teeth Cleaning, Dental Scaling, Dental Polishing

Control; Test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital Heidelberg: lead

Study Sites (1)

University Hospital Heidelberg

Heidelberg, 69120, Germany

RECRUITING

Related Publications (2)

• 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.

  PMID: 23370377 BACKGROUND

• 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.

  PMID: 19335072 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid; Periodontitis; Gingivitis

Interventions

Dental Prophylaxis; Dental Scaling; Dental Polishing

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases

Intervention Hierarchy (Ancestors)

Periodontics; Dentistry; Preventive Dentistry

Study Officials

• Diana Wolff, Prof. Dr. med. dent.

  University Hospital Heidelberg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diana Wolff, Prof. Dr. med. dent.

CONTACT

+49 (0)6221-56-6589; diana.wolff@med.uni-heidelberg.de

Kyrill Schoilew, Dr. med. dent.

CONTACT

kyrill.schoilew@med.uni-heidelberg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Medical Director, Department of Conservative Dentistry

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: March 22, 2017
• Study Start: February 28, 2017
• Primary Completion: August 1, 2019
• Study Completion: February 1, 2020
• Last Updated: May 8, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)