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

Primary Purpose

Periodontal Diseases

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
ELISA
Sponsored by
Necmettin Erbakan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Periodontal Diseases focused on measuring Gingival Crevicular Fluid, Irisin, Periodontitis, Sclerostin

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Necmettin Erbakan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

systemically healthy and periodontitis

type 2 diabetes and periodontitis

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
April 16, 2023
Last Updated
May 7, 2023
Sponsor
Necmettin Erbakan University
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1. Study Identification

Unique Protocol Identification Number
NCT05862311
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 12, 2020 (Actual)
Primary Completion Date
September 12, 2020 (Actual)
Study Completion Date
March 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Necmettin Erbakan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases
Keywords
Gingival Crevicular Fluid, Irisin, Periodontitis, Sclerostin

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
systemically healthy and periodontitis
Arm Type
Experimental
Arm Title
type 2 diabetes and periodontitis
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
ELISA
Intervention Description
ELISA(enzyme-linked immunosorbent assay)
Primary Outcome Measure Information:
Title
Evaluation of bone metabolism biomarkers in different periodontal conditions
Description
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.
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Probing pocket depth
Description
Probing pocket depth(PPD) was measured for determining the severity of the disease and clinical outcome. High probing depth shows more severe periodontal disease.
Time Frame
baseline
Title
gingival index
Description
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.
Time Frame
baseline
Title
Plaque index
Description
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.
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Necmettin Erbakan University
City
Konya
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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