Experimental study of periodontitis and rheumatoid arthritis
| ISRCTN | ISRCTN79186420 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79186420 |
| Secondary identifying numbers | PHRC 10.046.08 |
- Submission date
- 12/10/2011
- Registration date
- 20/03/2012
- Last edited
- 19/02/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
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
Contact information
Scientific
Faculty of Dental Surgery
CHU de Toulouse
3 Chemin des Maraîchers
Cedex 9
Toulouse
31400
France
| vergnes.jn@chu-toulouse.fr |
Study information
| Study design | Randomized controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Efficacy of therapeutic management of periodontitis on the clinical manifestations of rheumatoid arthritis: a randomized controlled trial |
| Study 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(s) | 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 |
| 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 |
| Primary outcome measure | 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 study start date | 01/12/2011 |
| Overall study end date | 30/06/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Total final enrolment | 22 |
| 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 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
Study participating centre
31400
France
Sponsor information
Hospital/treatment centre
Directorate of Research and Innovation
Hôtel Dieu
2 Rue Viguerie
Cedex 9
Toulouse
31059
France
| algans.n@chu-toulouse.fr | |
| Website | http://www.chu-toulouse.fr/ |
"ROR" |
https://ror.org/017h5q109 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 14/08/2013 | Yes | No | |
| Results article | results | 01/10/2019 | 19/02/2021 | Yes | No |
Editorial Notes
19/02/2021: Publication reference and total final enrolment added.
09/08/2016: Plain English summary added.
