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Experimental Study of PEriodontitis and Rheumatoid Arthritis
ISRCTN ISRCTN79186420
DOI 10.1186/ISRCTN79186420
ClinicalTrials.gov identifier
EudraCT number
Public title Experimental Study of PEriodontitis and Rheumatoid Arthritis
Scientific title Efficacy of therapeutic management of periodontitis on the clinical manifestations of rheumatoid arthritis: a randomized controlled trial
Acronym ESPERA
Serial number at source PHRC 10.046.08
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
Lay summary Lay summary under review 2
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
Countries of recruitment France
Disease/condition/study domain Rheumatoid arthritis and Periodontitis
Participants - 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
Participants - 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
Anticipated start date 01/12/2011
Anticipated end date 30/06/2013
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 40
Interventions 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.
Primary outcome measure(s) Difference between 3-month and baseline DAS 28 scores
Secondary outcome measure(s) 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)
Sources of funding University Hospital of Toulouse - Hospital Clinical Research Programme [CHU Toulouse - Programme Hospitalier de Recherche Clinique] (France) ref: 1004608
Trial website
Publications 2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23945051
Contact name Dr  Jean-Noel  Vergnes
  Address Faculty of Dental Surgery
CHU de Toulouse
3 Chemin des Maraîchers
Cedex 9
  City/town Toulouse
  Zip/Postcode 31400
  Country France
  Email vergnes.jn@chu-toulouse.fr
Sponsor University Hospital of Toulouse (CHU de Toulouse) (France)
  Address Directorate of Research and Innovation
Hôtel Dieu
2 Rue Viguerie
Cedex 9
  City/town Toulouse
  Zip/Postcode 31059
  Country France
  Email algans.n@chu-toulouse.fr
  Sponsor website: http://www.chu-toulouse.fr/
Date applied 12/10/2011
Last edited 25/10/2013
Date ISRCTN assigned 20/03/2012
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