The Effect of Non-Surgical Periodontal Therapy on Rheumatoid Arthritis

June 19, 2025 updated by: Burcu KARADUMAN, Biruni University

Evaluation of the Effect of Non-Surgical Periodontal Therapy on Serum and Salivary Biomarker Levels in Individuals With Rheumatoid Arthritis

Periodontitis is a common chronic inflammatory disease characterised by the destruction of the soft and hard tissues supporting the tooth, including alveolar bone, periodontal ligament and cementum. Periodontitis has been associated with different host characteristics such as diabetes or neutrophil disorders and environmental factors such as smoking, alcohol consumption and stress. On the other hand, periodontal bacterial infection triggers a systemic immune response that is associated with an increased risk of different disorders such as bacterial pneumonia, cardiovascular disease and autoimmune diseases. Rheumatoid arthritis (RA) is a severe chronic autoimmune disease of unknown etiology, characterised by symmetrical, erosive synovitis of the joints, sometimes with multisystem organ involvement, joint destruction and excessive bone loss. Although the etiology of RA is unknown, it is thought to occur in individuals with genetic predisposition as a result of exposure to various environmental factors. RA and periodontitis are chronic destructive inflammatory diseases with common genetic and environmental risk factors, pathogenesis mechanisms and complex multifactorial pathological processes. Several studies suggest that periodontitis, a common inflammatory disease of the periodontium surrounding the teeth and triggered by bacteria in the mouth, is associated with RA and may initiate and worsen inflammation in RA. Non-surgical periodontal treatment (COPT), which is considered the gold standard in the treatment of periodontitis with hand instruments and ultrasonic instruments, has been shown to provide significant improvements in the clinical outcomes of periodontitis patients with RA. COPT is performed to stop the progression of periodontal diseases. Considering the studies supporting the bidirectional relationship between periodontitis and RA, it is thought that COPT may affect the clinical and biochemical values of RA. Based on these points, the aim of our study was to investigate the relationship between serum and salivary ANGPTL-4, MMP-13, TNF-α and IL-6 levels and periodontal disease in individuals with RA and to evaluate the effects of COPT on RA disease severity in vivo.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
      • İstanbul, Turkey, 34025
        • Biruni University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • To be between the ages of 18-65,
  • Having at least 8 teeth excluding wisdom teeth,
  • No periodontal treatment in the last 3 months,
  • Not having used antibiotics in the last 3 months,
  • Not being pregnant or breastfeeding,
  • The individuals to be included in the control group should not have any systemic disease that may change the periodontal status, and the individuals to be included in the experimental group should not have any systemic disease that may affect periodontal health except RA.

Exclusion Criteria:

  • Under 18 years of age and over 65 years of age,
  • Having less than 8 teeth,
  • Having undergone periodontal treatment in the last 3 months,
  • Having used antibiotics in the last 3 months,
  • Being pregnant or breastfeeding,
  • Individuals to be included in the control group should have any systemic disease that may change the periodontal status, and individuals to be included in the test group should have any systemic disease that may affect periodontal health except RA.
  • Abnormal body mass index (more than 29.9 kg/m2).

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: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Clinical Healthy
Clinical measurements (Plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing) salivary sample and serum will be taken from all individuals at the beginning of the study. ANGPTL-4 levels will be examined to evaluate before and after treatment in periodontal health and periodontitis. A pre-treatment saliva sample and serum will be collected from the clinically healthy group.
Other: ELISA (Enzyme-Linked ImmunoSorbent Assay)
In this study, 15 periodontitis patients with RA, 15 healthy individuals with RA, 15 systemic healthy periodontitis patients and 15 systemic periodontally healthy individuals will be included. ANGPTL-4 biomarker and other biomarkers (MMP-13, TNF-α, IL-6) that have not been previously analysed in the serum and saliva of both RA and periodontitis patients will be evaluated before and 3 months after COPT. Clinical parameters (Plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing), biochemical evaluations of serum, saliva and gingival samples will be performed and correlated with clinical parameters at baseline and 3 months after COPT in all individuals with periodontitis included in the study.
Experimental: Periodontitis
Non-surgical periodontal treatment will be applied to individuals with periodontitis, clinical measurements, saliva collection and serum will be repeated 12 weeks after the treatment. ANGPTL-4 analysis will be performed by ELISA in saliva and serum of individuals. ANGPTL-4 levels will be examined to evaluate before and after treatment in periodontal health and periodontitis. Clinical measurements (Plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing) and salivary sample will be taken from all individuals at the beginning of the study.
Other: ELISA (Enzyme-Linked ImmunoSorbent Assay)
In this study, 15 periodontitis patients with RA, 15 healthy individuals with RA, 15 systemic healthy periodontitis patients and 15 systemic periodontally healthy individuals will be included. ANGPTL-4 biomarker and other biomarkers (MMP-13, TNF-α, IL-6) that have not been previously analysed in the serum and saliva of both RA and periodontitis patients will be evaluated before and 3 months after COPT. Clinical parameters (Plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing), biochemical evaluations of serum, saliva and gingival samples will be performed and correlated with clinical parameters at baseline and 3 months after COPT in all individuals with periodontitis included in the study.
Experimental: Periodontitis with rheumatoid arthritis
Non-surgical periodontal treatment will be applied to individuals with periodontitis, clinical measurements, saliva collection and serum will be repeated 12 weeks after the treatment. ANGPTL-4 analysis will be performed by ELISA in saliva and serum of individuals. ANGPTL-4 levels will be examined to evaluate before and after treatment in periodontitis with rheumatoid arthritis. Clinical measurements (Plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing) and salivary sample will be taken from all individuals at the beginning of the study.
Other: ELISA (Enzyme-Linked ImmunoSorbent Assay)
In this study, 15 periodontitis patients with RA, 15 healthy individuals with RA, 15 systemic healthy periodontitis patients and 15 systemic periodontally healthy individuals will be included. ANGPTL-4 biomarker and other biomarkers (MMP-13, TNF-α, IL-6) that have not been previously analysed in the serum and saliva of both RA and periodontitis patients will be evaluated before and 3 months after COPT. Clinical parameters (Plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing), biochemical evaluations of serum, saliva and gingival samples will be performed and correlated with clinical parameters at baseline and 3 months after COPT in all individuals with periodontitis included in the study.
Experimental: Healthy individuals with RA
Clinical measurements (Plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing) salivary sample and serum fluid will be taken from all individuals at the beginning of the study. ANGPTL-4 levels will be examined to evaluate before and after treatment in periodontal health and periodontitis. A pre-treatment saliva sample and serum will be collected from the healthy individuals with RA group.
Other: ELISA (Enzyme-Linked ImmunoSorbent Assay)
In this study, 15 periodontitis patients with RA, 15 healthy individuals with RA, 15 systemic healthy periodontitis patients and 15 systemic periodontally healthy individuals will be included. ANGPTL-4 biomarker and other biomarkers (MMP-13, TNF-α, IL-6) that have not been previously analysed in the serum and saliva of both RA and periodontitis patients will be evaluated before and 3 months after COPT. Clinical parameters (Plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing), biochemical evaluations of serum, saliva and gingival samples will be performed and correlated with clinical parameters at baseline and 3 months after COPT in all individuals with periodontitis included in the study.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Examination of ANGPTL-4 levels of periodontal disease and rheumatoid arthritis
Time Frame: up to 1 year
Examination of ANGPTL-4 levels, which are stated to be associated with periodontal disease, in serum and saliva samples obtained from individuals with periodontitis and periodontitis individuals with RA.
up to 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluation of the effect of non-surgical periodontal treatment on changes in ANGPTL-4 level.
Time Frame: up to 1 year
Evaluation of the effect of non-surgical periodontal treatment on changes in ANGPTL-4 level.
up to 1 year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Comparison biomarkers of study groups.
Time Frame: up to 1 year
Comparison of serum and saliva samples taken before treatment in individuals with periodontitis and periodontitis individuals with RA in terms of ANGPTL-4 levels.
up to 1 year

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biruni University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 7, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2015-KAEK-80-23-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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