PeriodontitisNCT02441920
Chronic Periodontitis and Tooth Loss in Patients With Rheumatoid Arthritis
An observational study of Periodontitis and Rheumatoid Arthritis, run by University of Birmingham.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis, Rheumatoid Arthritis
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Nov 2010to Nov 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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."
Who may be able to join
- 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
Who cannot join
- No absolute exclusion criteria
About this study
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.
Read the detailed description
Chronic periodontitis is arguably the most prevalent chronic inflammatory disease in humans. The defining feature of periodontitis is chronic inflammation of the tooth-supporting tissues, leading to the progressive destruction of periodontal ligament and alveolar bone. Periodontitis is a very common disease, affecting over 30% of adults aged 65 years or above in the UK. Results from a growing number of clinical studies point towards a potential association between chronic periodontitis and systemic rheumatic diseases- in particular, rheumatoid arthritis (RA). If proven, such an association would be very important from a clinical and public health perspective for several reasons. First, there are several processes through which chronic periodontitis might be part of a causal pathway in the pathogenesis and/or disease activity status of RA. Given the high prevalence of chronic periodontitis, a large proportion of the incidence and/or morbidity of RA could be attributable to chronic periodontitis, if causality was confirmed.
Importantly, chronic periodontitis would represent a modifiable risk factor, as effective treatments for this disease are available. Second, chronic periodontitis would contribute to morbidity in patients with RA even if the association was noncausal. Periodontitis is a leading cause of tooth loss in adults, which can have important clinical consequences, including impaired nutritional status and quality of life. Furthermore, chronic periodontitis is associated with an increased incidence of coronary heart disease and stroke, and emerging evidence indicates that this association might, in part, be causal, and thus periodontitis may contribute to the increased cardiovascular morbidity and mortality in RA.
- Conditions
- Periodontitis, Rheumatoid Arthritis
- Medical subject headings
- Periodontitis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with rheumatoid arthritis | The inception cohort of 400 patients will be followed up for 20 years following recruitment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Associations between periodontal parameters and RA related factors including disease activity, severity, progression, and comorbidities
incomplete student research project
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startNov 2010
- Primary completionNov 2012
- Study completionNov 2012
Why it stopped: Incomplete student research project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Dudley Group NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Paola de Pablo, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02441920
- Sponsor's protocol ID
- RG_09-196
- Status last verified
- Feb 2017
- First submitted
- 8 May 2015
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Periodontitis and Tooth Loss in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT02441920
- Acronym / sponsor ID
- RG_09-196
- Conditions
- Periodontitis, Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Incomplete student research project
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- Dudley Group NHS Foundation Trust
- Study start
- Nov 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 12 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chronic periodontitis is arguably the most prevalent chronic inflammatory disease in humans. The defining feature of periodontitis is chronic inflammation of the tooth-supporting tissues, leading to the progressive destruction of periodontal ligament and alveolar bone. Periodontitis is a very common disease, affecting over 30% of adults aged 65 years or above in the UK. Results from a growing number of clinical studies point towards a potential association between chronic periodontitis and systemic rheumatic diseases- in particular, rheumatoid arthritis (RA). If proven, such an association would be very important from a clinical and public health perspective for several reasons. First, there are several processes through which chronic periodontitis might be part of a causal pathway in the pathogenesis and/or disease activity status of RA. Given the high prevalence of chronic periodontitis, a large proportion of the incidence and/or morbidity of RA could be attributable to chronic periodontitis, if causality was confirmed.
Importantly, chronic periodontitis would represent a modifiable risk factor, as effective treatments for this disease are available. Second, chronic periodontitis would contribute to morbidity in patients with RA even if the association was noncausal. Periodontitis is a leading cause of tooth loss in adults, which can have important clinical consequences, including impaired nutritional status and quality of life. Furthermore, chronic periodontitis is associated with an increased incidence of coronary heart disease and stroke, and emerging evidence indicates that this association might, in part, be causal, and thus periodontitis may contribute to the increased cardiovascular morbidity and mortality in RA.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with rheumatoid arthritis | – | –The inception cohort of 400 patients will be followed up for 20 years following recruitment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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."
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- No absolute exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Associations between periodontal parameters and RA related factors including disease activity, severity, progression, and comorbidities
Time frame: 1 year
incomplete student research project
Results and safety
The study was stopped early (reason given: Incomplete student research project). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paola de Pablo principal investigator
University of Birmingham
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis and Rheumatoid Arthritis, run by University of Birmingham.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Incomplete student research project). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Associations between periodontal parameters and RA related factors including disease activity, severity, progression, and comorbidities (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.