Effect of Nonsurgical Periodontal Treatment on Apelin and Oxidative Stress Levels

July 27, 2025 updated by: Hatice Yemenoğlu

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

Study Type

Observational

Enrollment (Actual)

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 Locations

      • 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

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
Intervention / Treatment
Stage 1-2 periodontitis group
All participants will have their non-surgical periodontal treatments completed after samples are taken and periodontal measurements are taken at the beginning.
Periodontal measurements will be taken from all participants at baseline, 1 month, 3 months and 6 months
Gingival crevicular fluid samples will be collected from all participants at baseline, 1 month, 3 months and 6 months
Stage 3-4 periodontitis group
All participants will have their non-surgical periodontal treatments completed after samples are taken and periodontal measurements are taken at the beginning.
Periodontal measurements will be taken from all participants at baseline, 1 month, 3 months and 6 months
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

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

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.

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)

August 16, 2024

Primary Completion (Actual)

May 14, 2025

Study Completion (Actual)

June 14, 2025

Study Registration Dates

First Submitted

February 16, 2025

First Submitted That Met QC Criteria

February 25, 2025

First Posted (Actual)

February 28, 2025

Study Record Updates

Last Update Posted (Actual)

July 30, 2025

Last Update Submitted That Met QC Criteria

July 27, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Other Study ID 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.

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