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

April 17, 2025 updated by: Hatice Yemenoğlu

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Rize, Turkey, 53020
        • Recep Tayyip Erdogan University Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: control
Procedure: 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.
Other: 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).
Other: biochemical measurements
Serum and gingival crevicular fluid (GCF) samples will be collected from patients for biochemical evaluations.
Other: No medication will be administered to patients.
No medication will be administered to patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Periodontal pocket depth
Time Frame: 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
baseline, 3rd month after non-surgical periodontal therapy, 6th month after non-surgical periodontal therapy
clinical attachment loss
Time Frame: 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
baseline, 3rd month after non-surgical periodontal therapy, 6th month after non-surgical periodontal therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum and GCF receptor activator nuclear kappa B ligand (RANKL) level
Time Frame: 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.
baseline, after non-surgical periodontal therapy at 3 months, after non-surgical periodontal therapy at 6 months,
serum and GCF osteoprotegrin (OPG) level
Time Frame: 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.
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
Time Frame: 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.
baseline, after non-surgical periodontal therapy at 3 months, after non-surgical periodontal therapy at 6 months,
serum total antioxidant status (TAS) level
Time Frame: 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.
baseline, after non-surgical periodontal therapy at 3 months, after non-surgical periodontal therapy at 6 months,
serum total oxidant status (TAS) level
Time Frame: 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.
baseline, after non-surgical periodontal therapy at 3 months, after non-surgical periodontal therapy at 6 months,

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hatice Yemenoğlu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Actual)

April 18, 2025

Study Completion (Actual)

April 18, 2025

Study Registration Dates

First Submitted

February 2, 2025

First Submitted That Met QC Criteria

February 5, 2025

First Posted (Actual)

February 10, 2025

Study Record Updates

Last Update Posted (Actual)

April 23, 2025

Last Update Submitted That Met QC Criteria

April 17, 2025

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RecepTayyipErdogan University

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The requested data can be shared in a way that protects patient personal information.

IPD Sharing Time Frame

1 year as of 02.02.2025

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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