Effect of Nonsurgical Periodontal Treatment on Apelin and Oxidative Stress Levels

July 27, 2025 updated by: Hatice Yemenoğlu, Hatice Yemenoglu

Evaluation of the Effects of Nonsurgical Periodontal Treatment on Apelin and Oxidative Stress Levels in Individuals With Periodontitis

Periodontitis is a multifactorial, chronic inflammatory disease triggered by microorganisms in the dental biofilm. The limited data of clinical periodontal measurements in the diagnosis of periodontitis have led to the search for more reliable biomarkers that can be used in the diagnosis and follow-up of periodontal diseases. Apelin is another adipokine that has been investigated in a small number of studies so far; its receptor (apelin reseptor (APJ)) was first identified in 1993 and later isolated as a molecule in 1998. Studies have focused on this form of apelin-13 due to its high biological activity. Although apelin-13 is considered the most biologically active form, it has been shown that apelin-36 has a much higher binding affinity to APJ than apelin-13. Periodontitis is the most common cause of tooth loss in adults, and is associated with systemic conditions such as metabolic syndrome, diabetes mellitus, and cardiovascular disease. The elucidation of these possible interactions has been the focus of many studies. Apelin is associated with insulin secretion, as well as its effects on lipid and glucose metabolism. Studies in both humans and animals have shown that type 2 diabetes and obesity are typically associated with increased plasma apelin levels. Based on this observation, recent studies have shown that salivary and serum apelin levels are higher in individuals with chronic periodontitis and type 2 diabetes compared to healthy individuals. Considering all this information, the investigators considered that apelin may be a biomarker for periodontal diseases due to its inflammation-regulating effects as a result of the change in gingival crevicular fluid (GCF) apelin-13, apelin-36 and total oxidant status (TOS)/total antioxidant status (TAS) levels compared to the initial level after non-surgical periodontal treatment in systemically healthy and periodontitis individuals, considering the relationship of adipokines with periodontal disease in this study.

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.
Observational

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

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

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

No

Sampling Method

Non-Probability Sample

Study Population

periodontitis

Description

Inclusion Criteria:

  • Being systemically healthy
  • Not smoking
  • Not using anti-inflammatory drugs in the last 3 months, antibiotics and systemic corticosteroids in the last 6 months
  • Not being pregnant or lactating
  • Not having received periodontal treatment in the last 6 months
  • Having at least 20 teeth in the mouth
  • Being diagnosed with periodontitis (Stage 1-2 and Stage 3-4) by the researcher

Working groups will be formed based on the 2017 Periodontal Disease Classification

Exclusion Criteria:

being periodontally healthy having systemic disease being pregnant and lactating smoking having periodontal treatment in the last 6 months having fewer than 20 teeth

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Stage 1-2 periodontitis group
Procedure: non surgical periodontal therapy
All participants will have their non-surgical periodontal treatments completed after samples are taken and periodontal measurements are taken at the beginning.
Other: measurement of periodontal clinical parameters
Periodontal measurements will be taken from all participants at baseline, 1 month, 3 months and 6 months
Other: Gingival crevicular fluid samples will be collected
Gingival crevicular fluid samples will be collected from all participants at baseline, 1 month, 3 months and 6 months
Stage 3-4 periodontitis group
Procedure: non surgical periodontal therapy
All participants will have their non-surgical periodontal treatments completed after samples are taken and periodontal measurements are taken at the beginning.
Other: measurement of periodontal clinical parameters
Periodontal measurements will be taken from all participants at baseline, 1 month, 3 months and 6 months
Other: Gingival crevicular fluid samples will be collected
Gingival crevicular fluid samples will be collected from all participants at baseline, 1 month, 3 months and 6 months

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
Periodontal pocket depth
Time Frame: at baseline, 1 month, 3 months and 6 months
It will be calculated by measuring the distance between the gingival margin and the pocket base. Each tooth will be measured from six surfaces and averaged. higher scores indicate worse outcome.
at baseline, 1 month, 3 months and 6 months
clinical attachment loss
Time Frame: at baseline, 1 month, 3 months and 6 months
It will be calculated by measuring the distance between the cementoenamel border and the pocket base. It will be measured from the six surfaces of each tooth and the average will be taken. higher scores indicate worse outcome.
at baseline, 1 month, 3 months and 6 months

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
Apelin-13 level
Time Frame: at the beginning, at 1 month, at 3 months and at 6 months
Determination of the levels of apelin-13 from gingival crevicular fluid (GCF) samples will be done by ELISA method
at the beginning, at 1 month, at 3 months and at 6 months
Apelin-36 level
Time Frame: at baseline, 1 month, 3 months and 6 months
Determination of the levels of apelin-36 from gingival crevicular fluid (GCF) samples will be done by ELISA method
at baseline, 1 month, 3 months and 6 months
TOS (total oxidant status) level
Time Frame: at baseline, 1 month, 3 months and 6 months
Determination of the levels of TOS (total oxidant status) from gingival crevicular fluid (GCF) samples will be done by ELISA method
at baseline, 1 month, 3 months and 6 months
TAS (total antioxidant status) level
Time Frame: at baseline, 1 month, 3 months and 6 months
Determination of the levels of TAS (total antioxidant status) from gingival crevicular fluid (GCF) samples will be done by ELISA method
at baseline, 1 month, 3 months and 6 months

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.
Hatice Yemenoglu

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Recep Tayyip Erdogan University Training and Research Hospital

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.
August 16, 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.
May 14, 2025

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.
June 14, 2025

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).
February 16, 2025

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 25, 2025

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 28, 2025

Study Record Updates

Last Update Posted (Actual)

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.
July 30, 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.
July 27, 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.
July 1, 2025

More Information

Terms related to this study

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.
  • Recep TayyipErdoganUniversity

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

If deemed necessary, necessary information can be provided to protect patient confidentiality.

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings