Effect of Nonsurgical Periodontal Treatment on Apelin and Oxidative Stress Levels

NCT ID: NCT06850987

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-08-16
• Study Completion Date: 2025-06-14

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.

Conditions

Periodontitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Stage 1-2 periodontitis group

non surgical periodontal therapy

Intervention Type: 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

Intervention Type: 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

Intervention Type: OTHER

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

Stage 3-4 periodontitis group

non surgical periodontal therapy

Intervention Type: 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

Intervention Type: 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

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: PROCEDURE

measurement of periodontal clinical parameters

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

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Recep Tayyip Erdogan University Training and Research Hospital

OTHER

Sponsor Role: collaborator

Hatice Yemenoğlu

OTHER

Sponsor Role: lead

Responsible Party

Hatice Yemenoğlu

Principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Recep Tayyip Erdoğan University Faculty of Dentistry

Rize, Turkey, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Recep TayyipErdoganUniversity

Identifier Type: -

Identifier Source: org_study_id