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Effect Assessment of Periodontal Prophylaxis on Rheumatoid Arthritis Activity. (BHYRRA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Collaborator:
Société Française de Parodontologie et d'Implantologie Orale (SFPIO)
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01706874
First received: September 14, 2012
Last updated: June 13, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention
Patients With Anti-CCP Positive Early Rheumatoid Arthritis
Other: Periodontal prophylaxis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official 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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Periodontal prophylaxis [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
    Assessment of the effect of an intervention : periodontal prophylaxis (periodontal scaling + mouthwash + toothpaste)

  • Bacterial identification [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
    Assessment of the effect of an intervention: Bacterial identification. A bacterial sampling at 4 deepest periodontal pockets will be carried.


Secondary Outcome Measures:
  • Rate of anti-citrulline and anti P. gingivalis antibodies [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples Without DNA

Biospecimen: gingival fluid

A first sampling will take place at T0 and the second at Month 12 (test end).

A bacterial sampling at 4 deepest periodontal pockets will be carried. It will quantify the 9 following bacteria:

Aggregatibacter actinomycetemcomitans Porphyromonas gingivalis Prevotella intermedia Tannerella forsythensis Treponema denticola Peptostreptococcus micros Fusobacterium nucleatum Eikenella corrodens Campylobacter rectus


Estimated Enrollment: 200
Study Start Date: November 2012
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Periodontal prophylaxis
Periodontal prophylaxis (standard of care) versus control in rheumatoid arthritis patients.
Other: Periodontal prophylaxis
Periodontal scaling (every 6 months) plus mouthrinses plus toothbrushing (twice daily). Removal of adherent plaque and calculus with ultrasonic instruments and hand instruments, such as periodontal scalers and curettes, and polishing of the teeth
Other Name: Mouthrinse: Listerine®; toothpaste: Colgate Total®
Control
Periodontal prophylaxis (standard of care) versus control in rheumatoid arthritis patients

Detailed Description:

Introduction: Several epidemiological studies have suggested that a link between periodontal disease and rheumatoid arthritis. In cohorts, the risk of development of rheumatoid arthritis is increased in subjects with periodontal disease. The main bacterium implicated in chronic periodontal disease is Porphyromas gingivalis, a commensal microorganism of the mouth. P. gingivalis is the only microorganism with a deiminase capable of transforming arginine into citrulline, and is suspected of to play a major role in the production of anti-citrulline antibodies, the principal diagnostic marker of rheumatoid arthritis.

Hypotheses: The regular professional and individual plaque control in patients with rheumatoid arthritis (standard of care) - i.e. decreasing oral bacterial load, including P. gingivalis - reduces the activity of rheumatoid arthritis Principal objective: To assess the impact of professional periodontal scaling every 6 months combined with the individual plaque control, i.e. toothbrushing plus the use of mouthrinses on rheumatoid arthritis activity.

Methodology: The trial design is innovative and based on random selection of a sample of patients in an observational cohort of patients as described in the recent publication "Cohort Multiple Randomised Controlled Trials Design" (Ref.: BMJ 2010; 340: c1066). A randomly selected sample of eligible patients from the cohort will be asked to take part in the study. Changes in the randomised sample will be compared to those of other potentially eligible patients from the cohort. The cohort used will be the ESPOIR cohort, a cohort including 813 patients who initially presented with early undifferentiated polyarthritis that developed into rheumatoid arthritis with anti-citrulline antibodies in approximately 40 to 50% of cases.

Procedures studied: Periodontal scaling every 6 months and twice daily use of a mouthwash containing essential oils (Listerine®) plus a triclosan/copolymer toothpaste (Colgate Total®).

Sample size calculation: The principal assessment criterion is DAS variations at 1 year. The expected statistical power is 80% (the type I risk being set at 5%) and the standard deviation common to the two samples for DAS variation is evaluated at 1.5. With these hypotheses, the inclusion of 100 patients in the study group and 100 patients in the control group will produce an effect size of 0.40 (i.e. a difference in DAS between the two groups equal to 0.6).

Statistical analysis: A linear, mixed-effects model will be used to compare DAS variations between the two groups. In addition, the Mixed Model for Repeated Measurements (MMRM) based on a linear mixed model will include two other random effects, i.e.: the centre effect and the centre*treatment interaction effect, which will be used to measure heterogeneity between the centres and heterogeneity of the effect of the procedure. Finally, propensity scores with adjustment by weighting will be used to take into account any potential imbalances between the two study arms.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Population selected from the ESPOIR early arthritis Cohort

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01706874

Contacts
Contact: Philippe Bouchard, MD, PhD +33 6 14 65 69 47 phbouch@noos.fr
Contact: Laurence Lecomte, PhD +33 1 71 19 64 94 laurence.lecomte@nck.aphp.fr

Locations
France
Hôpital Rotschild - Service d'Odontologie Recruiting
Paris, France, 75571
Contact: Philippe Bouchard, MD, PhD    +33 6 14 65 69 47    phbouch@noos.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Société Française de Parodontologie et d'Implantologie Orale (SFPIO)
Investigators
Study Chair: Xavier Mariette Paris-Sud University
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01706874     History of Changes
Other Study ID Numbers: 2011- AO1271 - 40, 2011 - A 01271 - 41
Study First Received: September 14, 2012
Last Updated: June 13, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Rheumatoid arthritis
P.gingivalis
Periodontal disease
Plaque control
Prophylaxis
Oral hygiene instruction

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 25, 2014