NCT06993818

Brief Summary

Periodontal disease is a chronic, multifactorial inflammatory disease in which biochemical and cellular events trigger each other, leading to the destruction of the tissues supporting the teeth . The pathogenesis of the disease is a dynamic process that develops as a result of complex interactions between pathogenic bacteria and the host response . There is a bidirectional relationship between diabetes mellitus (DM), which is among the systemic diseases that negatively affect the host immune response, and periodontal disease. In the case of DM, long-term hyperglycemia causes proteins to react irreversibly with glucose, resulting in the formation of advanced glycation end products (AGEs). It is suggested that increased AGE levels increase cytokine secretion against periodontopathogens, exacerbate inflammatory tissue destruction, and may negatively affect biological functions through cell-cell and cell-matrix interactions in the connective tissue. The present study was conducted to gain further insight into the role of CGF and serum Asprosin level in the pathogenetic processes linking DM and periodontal disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2025

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 29, 2025

Completed
Last Updated

May 29, 2025

Status Verified

May 1, 2025

Enrollment Period

5 months

First QC Date

May 13, 2025

Last Update Submit

May 26, 2025

Conditions

Periodontal Diseases

Keywords

PeriodontitisDiabetes MellitusAsprosin levels

Outcome Measures

Primary Outcomes (1)

  • Changes in Asprosin Levels in GCF an Serum Samples in periodontal disease

    Investigators expect a statistically significant difference between controlled and uncontrolled T2DM and CP patients and healthy individuals in terms of serum and CGF Asprosin levels.

    6 Mounth

Study Arms (4)

Control Group: systemically and periodontally healthy control group

Periodontal clinical parameters and examination of asprosin levels in gingival crevicular fluid and serum samples

Other: Gingival Crevicular FluidDiagnostic Test: Serum Asprosin

Uncontrolled T2DM-CP: Stage III Grade C Periodontitis, Uncontrolled T2DM group

Periodontal clinical parameters and examination of asprosin levels in gingival crevicular fluid and serum samples

Other: Gingival Crevicular FluidDiagnostic Test: Serum Asprosin

Controlled T2DM-CP: Stage III Grade B Periodontitis, Controlled T2DM

Periodontal clinical parameters and examination of asprosin levels in gingival crevicular fluid and serum samples

Other: Gingival Crevicular FluidDiagnostic Test: Serum Asprosin

CP: Stage III Grade B Periodontitis group

Periodontal clinical parameters and examination of asprosin levels in gingival crevicular fluid and serum samples

Other: Gingival Crevicular FluidDiagnostic Test: Serum Asprosin

Interventions

Gingival Crevicular FluidOTHER

Periodontal clinical parameters and examination of asprosin levels in gingival crevicular fluid and serum samples

CP: Stage III Grade B Periodontitis groupControl Group: systemically and periodontally healthy control groupControlled T2DM-CP: Stage III Grade B Periodontitis, Controlled T2DMUncontrolled T2DM-CP: Stage III Grade C Periodontitis, Uncontrolled T2DM group
Serum AsprosinDIAGNOSTIC_TEST

Periodontal clinical parameters and examination of asprosin levels in gingival crevicular fluid and serum samples

CP: Stage III Grade B Periodontitis groupControl Group: systemically and periodontally healthy control groupControlled T2DM-CP: Stage III Grade B Periodontitis, Controlled T2DMUncontrolled T2DM-CP: Stage III Grade C Periodontitis, Uncontrolled T2DM group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients applying to Kahramanmaraş Sütçü İmam University, Faculty of Dentisrty, Department of Periodontology.

You may qualify if:

  • The patient must be a volunteer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaraş Sütçü İmam University

Kahramanmaraş, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Periodontal DiseasesPeriodontitisDiabetes Mellitus

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 13, 2025

First Posted

May 29, 2025

Study Start

November 1, 2024

Primary Completion

April 1, 2025

Study Completion

April 15, 2025

Last Updated

May 29, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

I dont want to share

Locations

TU(1)