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

NCT06818045 | Completed

• 1 other identifier: RecepTayyipErdogan University
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Peridontal Disease; Rheumatic Arthritis

Keywords

rheumatoid arthritis; periodontal disease; inflammation

Outcome Measures

Primary Outcomes (2)

• Periodontal pocket depth

  The distance between the pocket base and the gingival margin is measured

  baseline, 3rd month after non-surgical periodontal therapy, 6th month after non-surgical periodontal therapy

• clinical attachment loss

  The distance between the pocket base and the cementoenamel junction is measured

  baseline, 3rd month after non-surgical periodontal therapy, 6th month after non-surgical periodontal therapy

Secondary Outcomes (5)

• 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,

• serum and GCF osteoprotegrin (OPG) level

  baseline, after non-surgical periodontal therapy at 3 months, after non-surgical periodontal therapy at 6 months,

• 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,

• serum total antioxidant status (TAS) level

  baseline, after non-surgical periodontal therapy at 3 months, after non-surgical periodontal therapy at 6 months,

• serum total oxidant status (TAS) level

  baseline, after non-surgical periodontal therapy at 3 months, after non-surgical periodontal therapy at 6 months,

Study Arms (1)

control

EXPERIMENTAL

Procedure: Non Surgical Periodontal Treatment; Other: Periodontal measurements will be performed; Other: biochemical measurements; Other: No medication will be administered to patients.

Interventions

Non Surgical Periodontal Treatment PROCEDURE

This procedure will be applied to all patients. All patients received nonsurgical periodontal treatment. Scaling root planing and subgingival debridement were performed.

control

Periodontal measurements will be performed OTHER

Periodontal measurements will be performed on all patients (plaque index, gingival index, bleeding on probing, periodontal pocket depth, clinical attachment loss).

control

biochemical measurements OTHER

Serum and gingival crevicular fluid (GCF) samples will be collected from patients for biochemical evaluations.

control

No medication will be administered to patients. OTHER

No medication will be administered to patients.

control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hatice Yemenoğlu: lead

Study Sites (1)

Recep Tayyip Erdoğan University Faculty of Dentistry

Rize, 53020, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 18050377 BACKGROUND

MeSH Terms

Conditions

Rheumatic Fever; Arthritis, Rheumatoid; Periodontal Diseases; Inflammation

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 2, 2025
• First Posted: February 10, 2025
• Study Start: March 1, 2024
• Primary Completion: April 18, 2025
• Study Completion: April 18, 2025
• Last Updated: April 23, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 1 year as of 02.02.2025

Locations

TU (1)