NCT05880303Completed
Effect of Nonsurgical Periodontal Therapy (NSPT) on Rheumatoid Arthritis Subjects With Periodontitis
Effect of Nonsurgical Periodontal Therapy (NSPT) on Inflammatory Mediators, Subgingival Microbiota and Quality of Life Impacts in Rheumatoid Arthritis Subjects With Periodontitis
Source: ClinicalTrials.gov · Last updated 5 Dec 2025
Brief summary (registry, in English)
Periodontitis (PD), a chronic inflammatory disease which results in irreversible attachment loss, bone destruction and, if left untreated, tooth loss. Rheumatoid arthritis (RA), is an autoimmune disease characterized as a chronic inflammatory disorder leading to synovial inflammation and destruction of cartilage and bone. RA and PD which are commonly seen in elderly have many similarities in terms of pathophysiology and clinical progression. Previous findings from the investigators reported that inflamed periodontal tissues of RA subjects with PD are a potential site for post translational modification of proteins as there was increase in presence of citrullinated and carbamylated proteins in gingival tissues. Autoantibodies to these proteins have been reported to be involved in loss of immune tolerance which leads to RA and its progression. Currently there are gaps in our knowledge concerning the effect of nonsurgical periodontal therapy (NSTP), comprising oral hygiene instructions, scaling and root surface debridement on presence of these autoantibodies and inflammatory outcomes of RA. It is hypothesized that reduction in periodontal inflammation may concurrently reduce the systemic inflammatory load which is responsible in perpetuating RA joint inflammation. Here, the investigators propose to perform a randomized, controlled, single-blinded study on RA subjects with stage 2 or 3 periodontitis to assess the effect of NSTP on the reduction of these autoantibodies and inflammatory mediators as well as RA related disease activity measures such as ESR, CRP and Disease Activity Score 28-joint count (DAS28). The investigators will also assess changes in subgingival microbiota associated with RA-PD in response to NSTP using next generation sequencing. This study will help determine if RA individuals could benefit from early and appropriate NSPT, thus reducing periodontal inflammation and a similar impact on RA disease could be expected. This will ultimately improve patients' quality of life and reduce societal burden related to increased patient discomfort and treatment costs.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 3 May 2023
- Start date
- 1 Jun 2023
- Primary completion date
- 31 May 2025
- Lead sponsor
- University of Malaya
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT05880303
What you commit to
- Study type: Interventional
- Participants enrolled: 20
- From 1 Jun 2023 to the primary completion date, 31 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who are on antibiotic use during the previous 3 months before study
- Patients who have received nonsurgical periodontal treatment within 4 months before the study.
- Patients who have any concurrent systemic or debilitating conditions such as uncontrolled diabetes.
Other illness
- Presence of acute dental pain or infections
Other
- Non Malaysian subjects
- Patients who are pregnant
Who the study is looking for
- All RA patients who fulfill the American College of Rheumatology (formerly the American Rheumatism Association) 2010 revised criteria for the classification of RA and who are unresponsive to conventional RA treatment.
- At least 3 sites with probing pocket depths (PPD) ≥4mm and 4 sites with clinical attachment level (CAL) ≥4mm distributed in at least 2 quadrants (Papapanou et al, 2018) and will be designated as having Stage II and Stage III periodontitis
- Patients should have a minimum of 12 teeth present.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universiti Malaya Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.