Effect of periodontal treatment on the clinical parameters of patients with rheumatoid arthritis: study protocol of the randomized, controlled ESPERA trial.
BACKGROUND
Rheumatoid arthritis (RA) is a chronic inflammatory disorder that leads to joint damage, deformity, and pain. It affects approximately 1% of adults in developed countries. Periodontitis is a chronic oral infection, caused by inflammatory reactions to gram-negative anaerobic bacteria, and affecting about 35 to 50% of adults. If left untreated, periodontitis can lead to tooth loss. A significant association has been shown to exist between periodontitis and RA in observational studies. Some intervention studies have suggested that periodontal treatment can reduce serum inflammatory biomarkers such as C-reactive protein, or erythrocyte sedimentation rate. We hypothesize that periodontitis could be an aggravating factor in patients with RA, and that its treatment would improve RA outcomes. The aim of this clinical trial is to assess the effect of periodontal treatment on the biological and clinical parameters of patients with RA.


METHODS
The ESPERA (Experimental Study of Periodontitis and Rheumatoid Arthritis) study is an open-label, randomized, controlled trial. Subjects with both RA and periodontitis will be recruited at two university hospitals in southwestern France. In total, 40 subjects will be randomized into two arms (intervention and control groups), and will be followed up for 3 months. Intervention will consist of full-mouth supra-gingival and sub-gingival non-surgical scaling and root planing, followed by systemic antibiotic therapy, local antiseptics, and oral hygiene instructions. After the 3-month follow-up period, the same intervention will be applied to the subjects randomized to the control group.The primary outcome will be change of in Disease Activity Score in 28 Joints (DAS28) at the end of the follow-up period. Secondary outcomes will be the percentages of subjects with 20%, 50%, and 70% improvement in disease according to the American College of Rheumatology criteria. Health-related quality of life assessments (the Health Assessment Questionnaire and the Geriatric Oral Health Assessment Index) will also be compared between the two groups.


CONCLUSIONS
Evidence-based management of potential aggravating factors in subjects with active RA could be of clinical importance, yet there are few randomized controlled trials on the effect of periodontal treatment on the clinical parameters of RA. The ESPERA trial is designed to determine if non-surgical periodontal treatment could improve clinical outcomes in patients with active RA, and the quality of life of these patients.


BACKGROUND
The ESPERA Trial was registered in Current Controlled Trials [ISRCTN79186420] on 2012/03/20. The trial started recruiting on 2012/03/06.
Department of Dentistry, Toulouse University Hospital, CHU de Toulouse and Toulouse Dental School, Paul Sabatier University, Toulouse, France. paul.monsarrat@gmail.com
Paul
P
Monsarrat
Jean-Noël
JN
Vergnes
Alain
A
Cantagrel
Nadège
N
Algans
Sarah
S
Cousty
Philippe
P
Kémoun
Caroline
C
Bertrand
Elise
E
Arrivé
Christophe
C
Bou
Cyril
C
Sédarat
Thierry
T
Schaeverbeke
Cathy
C
Nabet
Michel
M
Sixou
D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D000891:Anti-Infective Agents, Local / Q000627:therapeutic use; D001172:Arthritis, Rheumatoid / Q000175:diagnosis / Q000276:immunology / Q000628:therapy*; D002985:Clinical Protocols; D012534:Dental Scaling; D005602:France; D006785:Hospitals, University; D006801:Humans; D009910:Oral Hygiene; D010518:Periodontitis / Q000175:diagnosis / Q000276:immunology / Q000382:microbiology / Q000628:therapy*; D011237:Predictive Value of Tests; D011788:Quality of Life; D012107:Research Design; D016745:Root Planing; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D000891:Anti-Infective Agents, Local