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

Sponsor
Necmettin Erbakan University (Other)
Overall Status
Completed
CT.gov ID
NCT05862311
Collaborator
(none)
50
1
2
12
4.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: ELISA
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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
Actual Study Start Date :
Mar 12, 2020
Actual Primary Completion Date :
Sep 12, 2020
Actual Study Completion Date :
Mar 12, 2021

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. Evaluation of bone metabolism biomarkers in different periodontal conditions [baseline]

    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

  1. Probing pocket depth [baseline]

    Probing pocket depth(PPD) was measured for determining the severity of the disease and clinical outcome. High probing depth shows more severe periodontal disease.

  2. gingival index [baseline]

    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.

  3. Plaque index [baseline]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Necmettin Erbakan University Konya Turkey

Sponsors and Collaborators

  • Necmettin Erbakan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ummuhan Tekin Atay, principal investigator, Necmettin Erbakan University
ClinicalTrials.gov Identifier:
NCT05862311
Other Study ID Numbers:
  • Ummuhantekinatay.
First Posted:
May 17, 2023
Last Update Posted:
May 17, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ummuhan Tekin Atay, principal investigator, Necmettin Erbakan University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 17, 2023