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NCT Number: NCT06850987

Effect of Nonsurgical Periodontal Treatment on Apelin and Oxidative Stress Levels

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Recep Tayyip Erdoğan University Faculty of Dentistry

Rize, Turkey, 53020, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non surgical periodontal therapy

Procedure

All participants will have their non-surgical periodontal treatments completed after samples are taken and periodontal measurements are taken at the beginning.

measurement of periodontal clinical parameters

Other

Periodontal measurements will be taken from all participants at baseline, 1 month, 3 months and 6 months

Gingival crevicular fluid samples will be collected

Other

Gingival crevicular fluid samples will be collected from all participants at baseline, 1 month, 3 months and 6 months

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Hatice Yemenoğlu

Other

Collaborators

  • Recep Tayyip Erdogan University Training and Research Hospital

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 28, 2025
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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