Effect of Nonsurgical Periodontal Treatment on Apelin and Oxidative Stress Levels

Completed

• Conditions: Periodontitis

• Registration Number: NCT06850987
• Lead Sponsor: Hatice Yemenoğlu

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-16
• Study First Submitted: 2025-02-16
• Study First Submitted QC: 2025-02-25
• Study First Posted: 2025-02-28
• Primary Completion: 2025-05-14
• Study Completion: 2025-06-14
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-27
• Last Update Posted: 2025-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Periodontal pocket depth	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.
clinical attachment loss	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 Outcome Measures

Name	Time	Method
TOS (total oxidant status) level	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
TAS (total antioxidant status) level	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
Apelin-13 level	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
Apelin-36 level	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

Trial Locations

Locations (1)

Recep Tayyip Erdoğan University Faculty of Dentistry; 🇹🇷 Rize, Turkey