Nonsurgical Periodontal Treatment Combined With Anti-TNF-α in Patients With Rheumatoid Arthritis and Periodontitis

Not Applicable

Completed

• Conditions: Rheumatic Arthritis; Peridontal Disease

• Registration Number: NCT06818045
• Lead Sponsor: Hatice Yemenoğlu

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-01
• Status Verified: 2024-04
• Study First Submitted: 2025-02-02
• Study First Submitted QC: 2025-02-05
• Study First Posted: 2025-02-10
• Last Update Submitted: 2025-04-17
• Primary Completion: 2025-04-18
• Study Completion: 2025-04-18
• Last Update Posted: 2025-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Periodontal pocket depth	baseline, 3rd month after non-surgical periodontal therapy, 6th month after non-surgical periodontal therapy	The distance between the pocket base and the gingival margin is measured
clinical attachment loss	baseline, 3rd month after non-surgical periodontal therapy, 6th month after non-surgical periodontal therapy	The distance between the pocket base and the cementoenamel junction is measured

Secondary Outcome Measures

Name	Time	Method
serum and GCF osteoprotegrin (OPG) level	baseline, after non-surgical periodontal therapy at 3 months, after non-surgical periodontal therapy at 6 months,	OPG levels in serum and GCF will be measured with biochemical kits.
serum and GCF receptor activator nuclear kappa B ligand (RANKL) level	baseline, after non-surgical periodontal therapy at 3 months, after non-surgical periodontal therapy at 6 months,	RANKL levels in serum and GCF will be measured with biochemical kits.
serum and GCF matrix metalloproteinase 8 (MMP8) level	baseline, after non-surgical periodontal therapy at 3 months, after non-surgical periodontal therapy at 6 months,	MMP-8 levels in serum and GCF will be measured with biochemical kits.
serum total antioxidant status (TAS) level	baseline, after non-surgical periodontal therapy at 3 months, after non-surgical periodontal therapy at 6 months,	TAS levels in serum will be measured with biochemical kits.
serum total oxidant status (TAS) level	baseline, after non-surgical periodontal therapy at 3 months, after non-surgical periodontal therapy at 6 months,	TOS levels in serum will be measured with biochemical kits.

Trial Locations

Locations (1)

Recep Tayyip Erdoğan University Faculty of Dentistry; 🇹🇷 Rize, Turkey