- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06850987
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
Status
Completed
Conditions
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
-
-
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Rize, Turkey, 53020
- Recep Tayyip Erdogan University Faculty of Dentistry
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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.
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at baseline, 1 month, 3 months and 6 months
|
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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
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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
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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
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
Additional Relevant MeSH Terms
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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