Clinical trial NCT06245265: The Effect of Non-Surgical Periodontal Therapy on Rheumatoid Arthritis
Official title: Evaluation of the Effect of Non-Surgical Periodontal Therapy on Serum and Salivary Biomarker Levels in Individuals With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Periodontitis
Rheumatoid Arthritis
Keywords: Periodontititis
Rheumatoid arthritis
Cytokine
Lead sponsor: Biruni University
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Periodontitis is a common chronic inflammatory disease characterised by the destruction of the soft and hard tissues supporting the tooth, including alveolar bone, periodontal ligament and cementum. Periodontitis has been associated with different host characteristics such as diabetes or neutrophil disorders and environmental factors such as smoking, alcohol consumption and stress. On the other hand, periodontal bacterial infection triggers a systemic immune response that is associated with an increased risk of different disorders such as bacterial pneumonia, cardiovascular disease and autoimmune diseases. Rheumatoid arthritis (RA) is a severe chronic autoimmune disease of unknown etiology, characterised by symmetrical, erosive synovitis of the joints, sometimes with multisystem organ involvement, joint destruction and excessive bone loss. Although the etiology of RA is unknown, it is thought to occur in individuals with genetic predisposition as a result of exposure to various environmental factors. RA and periodontitis are chronic destructive inflammatory diseases with common genetic and environmental risk factors, pathogenesis mechanisms and complex multifactorial pathological processes. Several studies suggest that periodontitis, a common inflammatory disease of the periodontium surrounding the teeth and triggered by bacteria in the mouth, is associated with RA and may initiate and worsen inflammation in RA. Non-surgical periodontal treatment (COPT), which is considered the gold standard in the treatment of periodontitis with hand instruments and ultrasonic instruments, has been shown to provide significant improvements in the clinical outcomes of periodontitis patients with RA. COPT is performed to stop the progression of periodontal diseases. Considering the studies supporting the bidirectional relationship between periodontitis and RA, it is thought that COPT may affect the clinical and biochemical values of RA. Based on these points, the aim of our study was to investigate the relationship between serum and salivary ANGPTL-4, MMP-13, TNF-α and IL-6 levels and periodontal disease in individuals with RA and to evaluate the effects of COPT on RA disease severity in vivo.


Eligibility criteria: Inclusion Criteria:

* To be between the ages of 18-65,
* Having at least 8 teeth excluding wisdom teeth,
* No periodontal treatment in the last 3 months,
* Not having used antibiotics in the last 3 months,
* Not being pregnant or breastfeeding,
* The individuals to be included in the control group should not have any systemic disease that may change the periodontal status, and the individuals to be included in the experimental group should not have any systemic disease that may affect periodontal health except RA.

Exclusion Criteria:

* Under 18 years of age and over 65 years of age,
* Having less than 8 teeth,
* Having undergone periodontal treatment in the last 3 months,
* Having used antibiotics in the last 3 months,
* Being pregnant or breastfeeding,
* Individuals to be included in the control group should have any systemic disease that may change the periodontal status, and individuals to be included in the test group should have any systemic disease that may affect periodontal health except RA.
* Abnormal body mass index (more than 29.9 kg/m2).

Primary outcomes:
measure: Examination of ANGPTL-4 levels of periodontal disease and rheumatoid arthritis
timeFrame: up to 1 year
Secondary outcomes:
measure: Evaluation of the effect of non-surgical periodontal treatment on changes in ANGPTL-4 level.
timeFrame: up to 1 year
Other outcomes:
measure: Comparison biomarkers of study groups.
timeFrame: up to 1 year
Locations:
Study officials:
References: