The Effect of Non-Surgical Periodontal Therapy on Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Evaluation of the Effect of Non-Surgical Periodontal Therapy on Serum and Salivary Biomarker Levels in Individuals With Rheumatoid Arthritis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06245265
• Other study ID #: 2015-KAEK-80-23-02
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: March 1, 2025

Study information

• Verified date: February 2024
• Source: Biruni University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Periodontitis
• Rheumatoid Arthritis

Intervention

Other:
• ELISA (Enzyme-Linked ImmunoSorbent Assay)
In this study, 15 periodontitis patients with RA, 15 healthy individuals with RA, 15 systemic healthy periodontitis patients and 15 systemic periodontally healthy individuals will be included. ANGPTL-4 biomarker and other biomarkers (MMP-13, TNF-a, IL-6) that have not been previously analysed in the serum and saliva of both RA and periodontitis patients will be evaluated before and 3 months after COPT. Clinical parameters (Plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing), biochemical evaluations of serum, saliva and gingival samples will be performed and correlated with clinical parameters at baseline and 3 months after COPT in all individuals with periodontitis included in the study.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Biruni University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comparison biomarkers of study groups.	Comparison of serum and saliva samples taken before treatment in individuals with periodontitis and periodontitis individuals with RA in terms of ANGPTL-4 levels.	up to 1 year
Primary	Examination of ANGPTL-4 levels of periodontal disease and rheumatoid arthritis	Examination of ANGPTL-4 levels, which are stated to be associated with periodontal disease, in serum and saliva samples obtained from individuals with periodontitis and periodontitis individuals with RA.	up to 1 year
Secondary	Evaluation of the effect of non-surgical periodontal treatment on changes in ANGPTL-4 level.	Evaluation of the effect of non-surgical periodontal treatment on changes in ANGPTL-4 level.	up to 1 year