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

NCT ID: NCT06818045

Last Updated: 2025-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2025-04-18

Brief Summary

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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

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Conditions

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Peridontal Disease Rheumatic Arthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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control

Group Type EXPERIMENTAL

Non Surgical Periodontal Treatment

Intervention Type PROCEDURE

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

Periodontal measurements will be performed

Intervention Type OTHER

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

biochemical measurements

Intervention Type OTHER

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

No medication will be administered to patients.

Intervention Type OTHER

No medication will be administered to patients.

Interventions

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Non Surgical Periodontal Treatment

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

Intervention Type PROCEDURE

Periodontal measurements will be performed

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

Intervention Type OTHER

biochemical measurements

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

Intervention Type OTHER

No medication will be administered to patients.

No medication will be administered to patients.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hatice Yemenoğlu

OTHER

Sponsor Role lead

Responsible Party

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Hatice Yemenoğlu

Principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Recep Tayyip Erdoğan University Faculty of Dentistry

Rize, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 18050377 (View on PubMed)

Other Identifiers

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RecepTayyipErdogan University

Identifier Type: -

Identifier Source: org_study_id

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