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

NCT ID: NCT05862311

Last Updated: 2023-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-12

Study Completion Date

2021-03-12

Brief Summary

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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

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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.

Conditions

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Periodontal Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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systemically healthy and periodontitis

Group Type EXPERIMENTAL

ELISA

Intervention Type DIAGNOSTIC_TEST

ELISA(enzyme-linked immunosorbent assay)

type 2 diabetes and periodontitis

Group Type EXPERIMENTAL

ELISA

Intervention Type DIAGNOSTIC_TEST

ELISA(enzyme-linked immunosorbent assay)

Interventions

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ELISA

ELISA(enzyme-linked immunosorbent assay)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Necmettin Erbakan University

OTHER

Sponsor Role lead

Responsible Party

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Ummuhan Tekin Atay

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Necmettin Erbakan University

Konya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Ummuhantekinatay.

Identifier Type: -

Identifier Source: org_study_id

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