Condition category
Musculoskeletal Diseases
Date applied
12/10/2011
Date assigned
20/03/2012
Last edited
09/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Rheumatoid arthritis is a long-term (chronic) disease where the body’s immune system attacks the cells that line the joints by mistake, making them swollen, stiff and painful, and over time damaging the joint, cartilage and nearby bone. Periodontitis is a very common condition where the gums become swollen, sore or infected, leading to bleeding, loss of the tissue supporting the teeth, and tooth loss. Some studies have suggested a possible link between rheumatoid arthritis and periodontitis. The aim of this study is to assess the effectiveness of periodontal treatment at reducing rheumatoid arthritis symptoms, in patients suffering from both periodontitis and rheumatoid arthritis.

Who can participate?
Patients aged 18 or over with both rheumatoid arthritis and periodontitis

What does the study involve?
Participants’ periodontitis and rheumatoid arthritis symptoms are assessed at the first visit and they are randomly allocated to one of two groups to receive either immediate or delayed periodontal treatment. Periodontal treatment includes scaling to remove plaque and tartar from the teeth, root planing to clean under the gums and get rid of bacteria from the roots of the teeth, antibiotics, oral hygiene instructions and antiseptic mouthwash. Both groups attend a visit to strengthen their use of hygiene techniques 45 days later, and after another 45 days their periodontitis and rheumatoid arthritis symptoms are reviewed .

What are the possible benefits and risks of participating?
Participants may benefit from improved gum health and improved general health (reduction in rheumatoid arthritis symptoms, improved quality of life). The expected risks are those of periodontal treatment: sensitivity, gum recession, side effects of taking antibiotics, and dysgeusia (distortion of the sense of taste).

Where is the study run from?
Toulouse University Hospital - Purpan and Bordeaux University Hospital - Pellegrin (France)

When is the study starting and how long is it expected to run for?
December 2011 to June 2013

Who is funding the study?
University Hospital of Toulouse - Hospital Clinical Research Programme (France)

Who is the main contact?
Dr Jean-Noël Vergnes
jn.vergnes@free.fr

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jean-Noel Vergnes

ORCID ID

Contact details

Faculty of Dental Surgery
CHU de Toulouse
3 Chemin des Maraîchers
Cedex 9
Toulouse
31400
France
-
vergnes.jn@chu-toulouse.fr

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PHRC 10.046.08

Study information

Scientific title

Efficacy of therapeutic management of periodontitis on the clinical manifestations of rheumatoid arthritis: a randomized controlled trial

Acronym

ESPERA

Study hypothesis

1. To assess the effectiveness of periodontal treatment to reduce the severity of rheumatoid arthritis (RA), in patients suffering from both periodontitis and rheumatoid arthritis
2. Periodontal treatment reduce the severity of rheumatoid arthritis

Ethics approval

1. Committee for Protection of Research Subjects (Comité de Protection des Personnes [CPP]), Sud-Ouest Outre-Mer I, 11/07/2011
2. Sanitary Safety in Health Products Agency (Agence française de sécurité sanitaire des produits de santé [AFSSAPS]), 04/11/2010, ref: 2010-A00533-36

Study design

Randomized controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Rheumatoid arthritis and periodontitis

Intervention

A rheumatologist will assess periodontal and RA parameters at the first visit (V1), then the participants will be randomly assigned to one of two groups to receive immediate or delayed periodontal treatment.

Periodontal treatment will include non-surgical scaling and root planing, systemic antibiotherapy, oral health instructions and antiseptic prescription.

For the immediate treatment group, a dentist will perform periodontal treatment (V2) and will strengthen the implementation of hygiene techniques 45 days later (V3).

The delayed treatment group will receive periodontal treatment at V4, strengthening of hygiene measures 45 days later (V5), and rheumatological and periodontal reassessment after 45 days (V6). Thus, periodontal care will be equivalent in the 2 groups.

Periodontal and rheumatological features will be reviewed 45 days after V3 (at V4) for both groups. Variation between V1 and V4 will be compared between the two groups.

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

Difference between 3-month and baseline DAS 28 scores

Secondary outcome measures

Difference between 3-month and baseline values of the following:
1. American College of Rheumatology (ACR) scores
2. Health Assessment Questionnaire (HAQ) scores
3. General Oral Health Assessment Index (GOHAI) scores
4. Periodontal Inflamed Surface Area (PISA)

Overall trial start date

01/12/2011

Overall trial end date

30/06/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male or female, aged 18 years or older
2. Rheumatoid arthritis diagnosed since at least one year
3. Disease Activity Score (DAS 28) score between 3.2 and 5.1
4. No change to medication, dosage or formulation in RA treatment during the 3 months before the inclusion visit
5. At least six natural teeth with root
6. Subject with periodontitis, defined by the presence of one site with periodontal probing depth ≥ 4 mm and clinical attachment level ≥ 3 mm on at least 4 teeth
7. Subject able to understand and willing to provide written informed consent in French
8. Subject affiliated to the security system

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Acute oral infection, acute oral pain (including pulpitis), suspicious oral mucosal lesion, severe oral inflammation unrelated to periodontal conditions, or need for immediate tooth extractions
2. Planned hospitalization within 4 months after the screening visit
3. One or more known infectious diseases [Human immunodeficiency virus(HIV), hepatitis, infectious mononucleosis]
4. Known clinically significant renal disease (creatinine clearance <60 ml/min), or liver disease
5. Unbalanced diabetes
6. Known risk of endocarditis
7. Have a permanent pacemaker
8. Antithrombotic treatment
9. Severe difficulties in understanding written and spoken French
10. Pregnant, lactating, or plans to become pregnant during the study
11. Chronic disorder that requires chronic or intermittent use of antibiotics
12. Hypersensitivity to chlorhexidine gluconate
13. Participation in another study with an investigational compound
14. Contraindications to both amoxicillin and clindamycin
15. Contraindications to dental local anesthetic

Recruitment start date

01/12/2011

Recruitment end date

30/06/2013

Locations

Countries of recruitment

France

Trial participating centre

University Hospital of Toulouse (CHU de Toulouse)
Toulouse
31400
France

Sponsor information

Organisation

University Hospital of Toulouse (CHU de Toulouse) (France)

Sponsor details

Directorate of Research and Innovation
Hôtel Dieu
2 Rue Viguerie
Cedex 9
Toulouse
31059
France
-
algans.n@chu-toulouse.fr

Sponsor type

Hospital/treatment centre

Website

http://www.chu-toulouse.fr/

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospital of Toulouse - Hospital Clinical Research Programme [CHU Toulouse - Programme Hospitalier de Recherche Clinique] (France) ref: 1004608

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23945051

Publication citations

  1. Protocol

    Monsarrat P, Vergnes JN, Cantagrel A, Algans N, Cousty S, Kémoun P, Bertrand C, Arrivé E, Bou C, Sédarat C, Schaeverbeke T, Nabet C, Sixou M, Effect of periodontal treatment on the clinical parameters of patients with rheumatoid arthritis: study protocol of the randomized, controlled ESPERA trial., Trials, 2013, 14, 253, doi: 10.1186/1745-6215-14-253.

Additional files

Editorial Notes

09/08/2016: Plain English summary added.