Anti-CCP Positive Early Rheumatoid Arthritis Clinical Trial
— BHYRRAOfficial title:
Assessment of the Effect of an Intervention (Periodontal Scaling + Mouthwash + Toothpaste) to Reduce the Load on Oral Bacterial Activity of Rheumatoid Arthritis: a Randomized Trial Nested in the Cohort ESPOIR
Verified date | July 2017 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is to assess the impact of an intervention (scaled every 06 months associated with the use of mouthwash with essential oils (toothpaste and Listerine® 2 times / day containing polymer Triclosan (Colgate Total®)) on the activity of rheumatoid arthritis
Status | Completed |
Enrollment | 92 |
Est. completion date | July 26, 2017 |
Est. primary completion date | September 7, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Patients with rheumatoid arthritis according to EULAR criteria / ACR 2010 under 10 years of evolution - Patients included in the ESPOIR cohort - Patients with DAS28 > 3.2 - Anti-CCP positive and negative - Age: 18 years old to 80 years - Affiliated to social security Exclusion Criteria: - Refusal to participate in the study - DAS28 < 3.2 - Patient under guardianship - Participation in another protocol without agreement of the dentist - Not affiliated to social security |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Rotschild - Service d'Odontologie | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | Société Française de Parodontologie et d'Implantologie Orale (SFPIO) |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Periodontal prophylaxis | Assessment of the effect of an intervention : periodontal prophylaxis (periodontal scaling + mouthwash + toothpaste) | at 12 months | |
Primary | Bacterial identification | Assessment of the effect of an intervention: Bacterial identification. A bacterial sampling at 4 deepest periodontal pockets will be carried. | at 12 months | |
Primary | Disease activity score (DAS) 28 | at 12 months | ||
Secondary | Rate of anti-citrulline and anti P. gingivalis antibodies | Evaluate the impact of this intervention on the rate of anti-citrulline and anti P. gingivalis antibodies. A bacterial sampling at 4 deepest periodontal pockets will be carried. | at 12 months |