NCT07691060

Brief Summary

The goal of this observational study is to learn about how different periodontal health status affects the levels of asprosin (a hormone) and total oxidant/antioxidant status in the gingival crevicular fluid and blood serum of individuals with Type 2 diabetes. The main questions it aims to answer are: Do individuals with Type 2 diabetes and periodontal disease have different levels of asprosin and oxidative stress markers compared to diabetic individuals with healthy gingiva ? How do local changes in the gingiva relate to systemic (body-wide) biomarkers in diabetic patients? Participants with Type 2 diabetes will undergo a routine clinical periodontal examination to evaluate their gingival health. During their regular clinic visit, samples of fluid from around their gingiva (gingival crevicular fluid) and routine blood samples (serum) will be collected to measure and compare these biochemical markers

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2025

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

July 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2025

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2026

Completed
26 days until next milestone

First Posted

Study publicly available on registry

July 8, 2026

Completed
Last Updated

July 8, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

June 12, 2026

Last Update Submit

July 6, 2026

Conditions

Keywords

asprosinperiodontitisgingivitistotal oxidant statustotal antioxidant statusoxidative stress

Outcome Measures

Primary Outcomes (1)

  • Comparison of serum and gingival crevicular fluid asprosin levels among individuals with type 2 diabetes mellitus presenting different periodontal conditions.

    At a single study visit during enrollment

Secondary Outcomes (1)

  • Comparison of serum and gingival crevicular fluid total oxidant status and total antioxidant status levels among individuals with type 2 diabetes mellitus presenting different periodontal conditions.

    At a single study visit during enrollment

Study Arms (3)

Periodontal health

Systemic and periodontal health participants

Gingivitis

Type 2 Diabetes and gingivitis

Periodontitis

Type 2 Diabetes and periodontitis

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consisted of adults aged 18-65 years. The gingivitis and periodontitis groups included patients diagnosed with type 2 diabetes mellitus (T2DM), whereas the healthy control group consisted of systemically healthy individuals. Participants were required to be non-smokers, have more than 20 natural teeth, and have no systemic conditions or medication use that could affect the immune response of the periodontal tissues.

You may qualify if:

  • Patients with type 2 diabetes mellitus (T2DM) in the gingivitis and periodontitis groups
  • Systemically healthy individuals without any systemic disease in the healthy control group
  • Age between 18 and 65 years
  • Non-smokers
  • Individuals with no diseases or medication use that could alter the immune response of the periodontal tissues
  • Participants with more than 20 natural teeth

You may not qualify if:

  • Age younger than 18 years or older than 65 years
  • Smokers
  • Individuals with any disease or medication use that could alter the immune response of the periodontal tissues
  • Pregnant women
  • Individuals who had received periodontal treatment within the previous 6 months
  • Patients with type 1 diabetes mellitus (T1DM)
  • Individuals who had used antibacterial medications within the previous 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences Türkiye, Gülhane Faculty of Dentistry

Ankara, Ankara, 06100, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Periodontal DiseasesGingival DiseasesDiabetes Mellitus, Type 2ArachnodactylyPeriodontitisGingivitis

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesLimb Deformities, CongenitalMusculoskeletal AbnormalitiesMusculoskeletal DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfections

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

June 12, 2026

First Posted

July 8, 2026

Study Start

July 1, 2025

Primary Completion

December 17, 2025

Study Completion

December 30, 2025

Last Updated

July 8, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

De-identified individual participant data underlying the results reported in this study will be available upon reasonable request to the corresponding investigator following publication of the study results.

Locations