The Effect of Non-Surgical Periodontal Treatment on Bone Metabolism in Type 2 Diabetes and Systemically Healthy Individuals

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

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.

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases
• Intervention / Treatment: Diagnostic test: ELISA

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Konya, Turkey
    • Necmettin Erbakan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: systemically healthy and periodontitis	Diagnostic test: ELISA; ELISA(enzyme-linked immunosorbent assay)
Experimental: type 2 diabetes and periodontitis	Diagnostic test: ELISA; ELISA(enzyme-linked immunosorbent assay)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of bone metabolism biomarkers in different periodontal conditions	The levels of bone metabolism markers (such as sclerostin, irisin, IL-6, TNF-a, RANKL/OPG) in the gingival crevicular fluid of individuals with different periodontal conditions were compared using the ELISA (Enzyme Linked İmmünosorbent Assay) test, and the relationship of these markers with periodontal status was examined.	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing pocket depth	Probing pocket depth(PPD) was measured for determining the severity of the disease and clinical outcome. High probing depth shows more severe periodontal disease.	baseline
Plaque index	The differences in plaque index scores between periodontally healthy and periodontitis. Plaque index (PI) was recorded for determining and classifying oral hygiene status. The plaque index (PI) scores each site on a with 0 being no plaque in gingival area and 3 abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.	baseline
gingival index	The differences in gingival index scores between periodontally healthy and periodontitis.The gingival index was recorded for determining and classifying gingival status. The gingival index (Gİ) scores each site on a 0 being normal and 3 being severe inflammation characterized by edema, redness, swelling and spontaneous bleeding.	baseline

Collaborators and Investigators

• Sponsor: Necmettin Erbakan University

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2020
• Primary Completion (Actual): September 12, 2020
• Study Completion (Actual): March 12, 2021

Study Registration Dates

• First Submitted: April 16, 2023
• First Submitted That Met QC Criteria: May 7, 2023
• First Posted (Actual): May 17, 2023

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 7, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Periodontitis; Irisin; Sclerostin; Gingival Crevicular Fluid
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases
• Other Study ID Numbers: Ummuhantekinatay.

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No