This trial is active, not recruiting.

Conditions periodontitis, rheumatoid arthritis
Sponsor University of Birmingham
Collaborator Dudley Group NHS Foundation Trust
Start date November 2010
End date November 2012
Trial size 400 participants
Trial identifier NCT02441920, RG_09-196


Periodontitis is a highly prevalent chronic inflammatory disease that is characterized by loss of the periodontal ligament and alveolar bone, and is a major cause of tooth loss. Results from clinical and epidemiological studies have suggested that periodontitis and tooth loss are more prevalent in individuals with rheumatoid arthritis (RA). There is evidence to suggest that periodontitis could indeed be a causal factor in the initiation and maintenance of the autoimmune inflammatory response that occurs in RA. If so, chronic periodontitis might represent an important modifiable risk factor for RA. However, to date longitudinal studies on the effect of periodontitis on disease progression in RA are lacking. The aim of the present study is to assess the periodontal status of patients enrolled in an established longitudinal cohort of RA patients. These data will then be analysed to evaluate whether or not periodontal inflammation is related to parameters of rheumatoid arthritis.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective cross-sectional
The inception cohort of 400 patients will be followed up for 20 years following recruitment.

Primary Outcomes

Associations between periodontal parameters and RA related factors including disease activity, severity, progression, and comorbidities
time frame: 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Fulfilling the 1987 revised criteria for the classification of Rheumatoid arthritis - Under active follow−up by a rheumatologist at the Dudley Group of Hospitals - Participation in study 04/Q2702/18 "Establishment of an inception cohort for the prospective evaluation of predictors of cardiovascular morbidity and mortality in patients with rheumatoid arthritis". - Participation in study 04/Q2702/18 "A prospective study of micro and macro vascular disease in a cohort of patients with Rheumatoid arthritis"). - Written informed consent Exclusion Criteria: - No absolute exclusion criteria

Additional Information

Official title Chronic Periodontitis and Tooth Loss in Patients With Rheumatoid Arthritis
Principal investigator Paola de Pablo
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by University of Birmingham.