Clinical trial NCT06818045: Nonsurgical Periodontal Treatment Combined With Anti-TNF-α in Patients With Rheumatoid Arthritis and Periodontitis
Official title: Investigation of the Effect of Nonsurgical Periodontal Treatment Applied Together With Anti-TNF-α on Alveolar Bone Loss and Oxidative Stress in Patients With Rheumatoid Arthritis and Periodontitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peridontal Disease
Rheumatic Arthritis
Keywords: rheumatoid arthritis
periodontal disease
inflammation
Lead sponsor: Recep Tayyip Erdogan University Training and Research Hospital
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Periodontitis is a multifactorial disease of the periodontium that can lead to destruction of the alveolar bone and supporting connective tissue and subsequent tooth loss. Recent studies have shown that periodontitis is associated with age, smoking habits, genetic predisposition, socioeconomic status, and various systemic diseases such as diabetes mellitus, atherosclerosis, obesity, osteoporosis, and rheumatoid arthritis (RA). RA is a chronic, systemic inflammatory disease of unknown etiology that primarily affects the joints. Periodontitis and RA have similar clinical and pathogenic features. Clinically, both diseases are characterized by local destruction of hard and soft tissues. Their pathogenesis involves the release of cytokines and matrix metalloproteinases (MMPs) from inflammatory cells. Expression of proinflammatory cytokines such as tumor necrosis factor-alpha (TNF-α) leads to the release of high levels of inflammatory mediators that cause bone destruction and the spread of inflammation. TNF-α is the main regulatory cytokine in both RA and periodontitis. TNF-α inhibitors (anti-TNF-α) reduce the number of inflammatory cells, osteoclast formation and bone loss. In addition, many immunological processes have been identified that are similar to both diseases. Autoreactive T cells, natural killer cells, heat shock proteins, autoantibodies and genetic factors are reported to play an important role in the inflammatory pathway of RA and periodontitis.

Recently, TNF-α blocking agents (anti-TNF-α) have been developed and used for the treatment of RA. Animal and human studies have suggested that anti-TNF-α treatment may reduce the severity of periodontitis.

The aim of this study was to investigate the effect of nonsurgical periodontal treatment combined with anti-TNF-α on alveolar bone loss and oxidative stress in individuals with RA and periodontitis.


Eligibility criteria: Inclusion Criteria:

* Being between the ages of 18-65,
* Having a confirmed diagnosis of Rheumatoid Arthritis (RA),
* Having a diagnosis of Stage III-IV periodontitis,
* Having at least 20 teeth,

Exclusion Criteria:

* Having used antibiotics for the 3 months before the study,
* Being pregnant and lactating,
* Having received periodontal treatment in the last 6 months,
* Being diabetic.
* Smoking.

Primary outcomes:
measure: Periodontal pocket depth
timeFrame: baseline, 3rd month after non-surgical periodontal therapy, 6th month after non-surgical periodontal therapy
measure: clinical attachment loss
timeFrame: baseline, 3rd month after non-surgical periodontal therapy, 6th month after non-surgical periodontal therapy
Secondary outcomes:
measure: serum and GCF receptor activator nuclear kappa B ligand (RANKL) level
timeFrame: baseline, after non-surgical periodontal therapy at 3 months, after non-surgical periodontal therapy at 6 months,
measure: serum and GCF osteoprotegrin (OPG) level
timeFrame: baseline, after non-surgical periodontal therapy at 3 months, after non-surgical periodontal therapy at 6 months,
measure: serum and GCF matrix metalloproteinase 8 (MMP8) level
timeFrame: baseline, after non-surgical periodontal therapy at 3 months, after non-surgical periodontal therapy at 6 months,
measure: serum total antioxidant status (TAS) level
timeFrame: baseline, after non-surgical periodontal therapy at 3 months, after non-surgical periodontal therapy at 6 months,
measure: serum total oxidant status (TAS) level
timeFrame: baseline, after non-surgical periodontal therapy at 3 months, after non-surgical periodontal therapy at 6 months,
Other outcomes:
Locations:
city: Rize
country: Turkey
facility: Recep Tayyip Erdoğan University Faculty of Dentistry
Study officials:
References:
citation: de Pablo P, Dietrich T, McAlindon TE. Association of periodontal disease and tooth loss with rheumatoid arthritis in the US population. J Rheumatol. 2008 Jan;35(1):70-6. Epub 2007 Nov 15.