Effect of Nonsurgical Periodontal Treatment on Apelin and Oxidative Stress Levels

NCT06850987 | Completed

• 1 other identifier: Recep TayyipErdoganUniversity
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Periodontal pocket depth

  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

  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 Outcomes (4)

• Apelin-13 level

  at the beginning, at 1 month, at 3 months and at 6 months

• Apelin-36 level

  at baseline, 1 month, 3 months and 6 months

• TOS (total oxidant status) level

  at baseline, 1 month, 3 months and 6 months

• TAS (total antioxidant status) level

  at baseline, 1 month, 3 months and 6 months

Study Arms (2)

Stage 1-2 periodontitis group

Procedure: non surgical periodontal therapy; Other: measurement of periodontal clinical parameters; Other: Gingival crevicular fluid samples will be collected

Stage 3-4 periodontitis group

Procedure: non surgical periodontal therapy; Other: measurement of periodontal clinical parameters; Other: Gingival crevicular fluid samples will be collected

Interventions

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.

Stage 1-2 periodontitis group; Stage 3-4 periodontitis group

measurement of periodontal clinical parameters OTHER

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

Stage 1-2 periodontitis group; Stage 3-4 periodontitis group

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

Stage 1-2 periodontitis group; Stage 3-4 periodontitis group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

periodontitis

You may qualify if:

• 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

You may not qualify if:

• being periodontally healthy having systemic disease being pregnant and lactating smoking having periodontal treatment in the last 6 months having fewer than 20 teeth

Sponsors & Collaborators

• Hatice Yemenoğlu: lead
• Recep Tayyip Erdogan University Training and Research Hospital: collaborator

Study Sites (1)

Recep Tayyip Erdoğan University Faculty of Dentistry

Rize, Turkey, 53020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 16, 2025
• First Posted: February 28, 2025
• Study Start: August 16, 2024
• Primary Completion: May 14, 2025
• Study Completion: June 14, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

TU (1)