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Chronic Periodontitis and Tooth Loss in Patients With Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT02441920
Recruitment Status : Active, not recruiting
First Posted : May 12, 2015
Last Update Posted : February 9, 2017
Sponsor:
Collaborator:
Dudley Group NHS Foundation Trust
Information provided by (Responsible Party):
University of Birmingham

Brief Summary:
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.

Condition or disease
Periodontitis Rheumatoid Arthritis

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Chronic Periodontitis and Tooth Loss in Patients With Rheumatoid Arthritis
Study Start Date : November 2010
Actual Primary Completion Date : November 2012
Estimated Study Completion Date : November 2030

Resource links provided by the National Library of Medicine


Group/Cohort
Patients with rheumatoid arthritis
The inception cohort of 400 patients will be followed up for 20 years following recruitment.



Primary Outcome Measures :
  1. Associations between periodontal parameters and RA related factors including disease activity, severity, progression, and comorbidities [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients that have already consented to their participation in a co−existing study will be eligible for inclusion: 04/Q2702/18 submitted 08/06/ 2004 "Establishment of an inception cohort for the prospective evaluation of predictors of cardiovascular morbidity and mortality in patients with rheumatoid arthritis."
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02441920


Sponsors and Collaborators
University of Birmingham
Dudley Group NHS Foundation Trust
Investigators
Principal Investigator: Paola de Pablo University of Birmingham

Responsible Party: University of Birmingham
ClinicalTrials.gov Identifier: NCT02441920     History of Changes
Other Study ID Numbers: RG_09-196
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: February 9, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Periodontitis
Chronic Periodontitis
Tooth Loss
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases