Clinical trial NCT06850987: Effect of Nonsurgical Periodontal Treatment on Apelin and Oxidative Stress Levels
Official title: Evaluation of the Effects of Nonsurgical Periodontal Treatment on Apelin and Oxidative Stress Levels in Individuals With Periodontitis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Periodontitis
Lead sponsor: Recep Tayyip Erdogan University Training and Research Hospital
Sponsor class: OTHER
Collaborators: name: Recep Tayyip Erdogan University Training and Research Hospital
First posted: 2025-02-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: periodontitis

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.


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

Primary outcomes:
measure: Periodontal pocket depth
timeFrame: at baseline, 1 month, 3 months and 6 months
measure: clinical attachment loss
timeFrame: at baseline, 1 month, 3 months and 6 months
Secondary outcomes:
measure: Apelin-13 level
timeFrame: at the beginning, at 1 month, at 3 months and at 6 months
measure: Apelin-36 level
timeFrame: at baseline, 1 month, 3 months and 6 months
measure: TOS (total oxidant status) level
timeFrame: at baseline, 1 month, 3 months and 6 months
measure: TAS (total antioxidant status) level
timeFrame: at baseline, 1 month, 3 months and 6 months
Other outcomes:
Locations:
city: Rize
country: Turkey
facility: Recep Tayyip Erdoğan University Faculty of Dentistry
Study officials:
References: