NCT02441920

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2010

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 12, 2015

Completed
Last Updated

April 19, 2024

Status Verified

February 1, 2017

Enrollment Period

2 years

First QC Date

May 8, 2015

Last Update Submit

April 17, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Associations between periodontal parameters and RA related factors including disease activity, severity, progression, and comorbidities

    incomplete student research project

    1 year

Study Arms (1)

Patients with rheumatoid arthritis

The inception cohort of 400 patients will be followed up for 20 years following recruitment.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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."

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

PeriodontitisArthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Paola de Pablo

    University of Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2015

First Posted

May 12, 2015

Study Start

November 1, 2010

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

April 19, 2024

Record last verified: 2017-02