Condition category
Musculoskeletal Diseases
Date applied
12/10/2011
Date assigned
20/03/2012
Last edited
25/10/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 2

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 July 2011
2. Sanitary Safety in Health Products Agency (Agence française de sécurité sanitaire des produits de santé [AFSSAPS]), 4 November 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

Other

Phase

Not Applicable

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

Faculty of Dental Surgery
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