Clinical trial NCT05862311: The Effect of Non-Surgical Periodontal Treatment on Bone Metabolism in Type 2 Diabetes and Systemically Healthy Individuals
Official title: The Effect of Non-Surgical Periodontal Therapy on Sclerostin, Irisin, RANKL \ OPG, IL-6 and TNF-α Levels in Type 2 Diabetes and Systemically Healthy Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Keywords: Gingival Crevicular Fluid
Irisin
Periodontitis
Sclerostin
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2023-05-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: In this study, it was concluded that sclerostin and irisin may be alternative markers for evaluating the effectiveness of periodontal treatment and healing of periodontal tissues by affecting bone metabolism.

Detailed description: Background: Diabetes and periodontitis are chronic inflammatory diseases with similar pathogenesis and clinical and immunological interrelationships. The aim of this study is to determine periodontal clinical parameters and sclerostin, irisin, Receptor Activator of Nuclear Factor κB Ligand (RANKL)/Osteoprotegerin (OPG), interleukin-6 (IL-6) and tumor necrosis factor-α (TNF-α) levels in gingival crevicular fluid (GCF) in individuals with type 2 diabetes and systemically healthy periodontitis and to evaluate the effect of non-surgical periodontal therapy on these clinical parameters and biomarkers.

Method: Within the scope of this study, applying to Necmettin Erbakan University Faculty of Dentistry Periodontology Clinic; A total of 50 individuals, including 25 patients with type 2 diabetes and periodontitis (DMP group) and 25 patients with systemically healthy and periodontitis (SSP group), were included in the study. After recording the clinical periodontal parameters (gingival index (GI), plaque index (PI), probing pocket depth (PPD), clinical attachment level (CAL)) of each individual included in the study, GCF samples were obtained and non-surgical periodontal therapy were completed. The individuals were invited to the controls 3 months later and the procedures for clinical periodontal measurements and DOS samples collection were repeated. Levels of biomarkers in DOS samples were determined by ELISA (Enzyme Linked Immunosorbent Assay) method.

Eligibility criteria: Inclusion Criteria:

* Having at least 20 teeth in the mouth, excluding the third molars,
* Individuals between the ages of 18-65
* Diagnosed as stage 2 or stage 3 periodontitis as a result of periodontal examination
* Those who do not have predisposing factors (restoration, caries, etc.)

Exclusion Criteria:

* Smoking or using alcohol,
* Any periodontal treatment performed in the last 6 months,
* Being in pregnancy and/or lactation period,
* Individuals who had received any anti-inflammatory, antibiotic, antioxidant or corticosteroid treatment in the last 6 months and refused to participate in the study were excluded from the study.

Primary outcomes:
measure: Evaluation of bone metabolism biomarkers in different periodontal conditions
timeFrame: baseline
Secondary outcomes:
measure: Probing pocket depth
timeFrame: baseline
measure: gingival index
timeFrame: baseline
measure: Plaque index
timeFrame: baseline
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Necmettin Erbakan University
Study officials:
References: