NCT07703345

Brief Summary

This observational cross-sectional study will evaluate salivary apelin, chemerin, ghrelin, and lipocalin-2 levels in individuals with different periodontal and systemic conditions. Participants will be divided into four groups according to periodontal status and the presence or absence of type 2 diabetes mellitus. Clinical periodontal measurements and unstimulated saliva samples will be obtained before periodontal treatment. Salivary biomarker levels will be measured using enzyme-linked immunosorbent assay kits. The study aims to determine whether salivary apelin, chemerin, ghrelin, and lipocalin-2 levels are associated with periodontitis, type 2 diabetes mellitus, and periodontal clinical parameters.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2026

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 14, 2026

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Completed
Last Updated

July 14, 2026

Status Verified

July 1, 2026

Enrollment Period

1 month

First QC Date

July 9, 2026

Last Update Submit

July 9, 2026

Conditions

Keywords

PeriodontitisType 2 Diabetes MellitusSalivary BiomarkersApelinChemerin

Outcome Measures

Primary Outcomes (1)

  • Salivary apelin, chemerin, ghrelin, and lipocalin-2 levels

    Salivary apelin, chemerin, ghrelin, and lipocalin-2 levels will be measured in unstimulated saliva samples collected before periodontal treatment. Biomarker levels will be analyzed using enzyme-linked immunosorbent assay kits and compared among the four study groups according to periodontal status and the presence or absence of type 2 diabetes mellitus.

    Baseline, before periodontal treatment

Study Arms (4)

Periodontally Healthy Systemically Healthy Group

Periodontally healthy individuals without type 2 diabetes mellitus or other systemic diseases.

Diagnostic Test: Salivary Biomarker Analysis

Periodontally Healthy Type 2 Diabetes Group

Periodontally healthy individuals diagnosed with type 2 diabetes mellitus.

Diagnostic Test: Salivary Biomarker Analysis

Periodontitis Systemically Healthy Group

Systemically healthy individuals diagnosed with generalized Stage II or Stage III periodontitis according to the 2017 World Workshop Classification.

Diagnostic Test: Salivary Biomarker Analysis

Periodontitis Type 2 Diabetes Group

Individuals diagnosed with both generalized Stage II or Stage III periodontitis and type 2 diabetes mellitus.

Diagnostic Test: Salivary Biomarker Analysis

Interventions

Unstimulated saliva samples will be collected from participants before periodontal treatment and before periodontal probing. Salivary apelin, chemerin, ghrelin, and lipocalin-2 levels will be measured using enzyme-linked immunosorbent assay kits according to the manufacturer's instructions. This procedure is used for biomarker assessment only and does not involve any therapeutic intervention.

Also known as: ELISA-based salivary biomarker measurement
Periodontally Healthy Systemically Healthy GroupPeriodontally Healthy Type 2 Diabetes GroupPeriodontitis Systemically Healthy GroupPeriodontitis Type 2 Diabetes Group

Eligibility Criteria

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

The study population will consist of individuals aged 18 to 80 years who apply to the Department of Periodontology, Faculty of Dentistry, Necmettin Erbakan University, meet the eligibility criteria, and agree to participate. Participants will be categorized into four groups according to periodontal status and the presence or absence of type 2 diabetes mellitus: periodontally healthy systemically healthy individuals, periodontally healthy individuals with type 2 diabetes mellitus, systemically healthy individuals with periodontitis, and individuals with both periodontitis and type 2 diabetes mellitus.

You may qualify if:

  • Individuals aged 18 to 80 years. Individuals who apply to the Department of Periodontology, Faculty of Dentistry, Necmettin Erbakan University.
  • Individuals who agree to participate in the study and sign the informed consent form.
  • Presence of at least 20 teeth. For the periodontally healthy groups: diagnosis of periodontal health based on routine clinical and radiographic examination.
  • For the periodontitis groups: diagnosis of generalized Stage II or Stage III periodontitis based on routine clinical and radiographic examination according to the 2017 World Workshop Classification of Periodontal and Peri-Implant Diseases and Conditions.
  • For the type 2 diabetes mellitus groups: diagnosis of type 2 diabetes mellitus. For the systemically healthy groups: absence of systemic diseases, including type 2 diabetes mellitus.

You may not qualify if:

  • Periodontal treatment, including scaling and root surface debridement, within the last 6 months.
  • Antibiotic use within the last 6 months. Pregnancy or lactation. Presence of autoimmune diseases such as rheumatoid arthritis, familial Mediterranean fever, ankylosing spondylitis, Behçet disease, or psoriasis.
  • Presence of systemic diseases other than type 2 diabetes mellitus in the diabetes groups.
  • Presence of systemic diseases such as nephrotic syndrome, chronic renal disease, or cardiovascular disease.
  • Smoking 10 or more cigarettes per day.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin Erbakan University Faculty of Dentistry, Department of Periodontology

Konya, Konya, 42090, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

PeriodontitisDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 9, 2026

First Posted

July 14, 2026

Study Start

July 1, 2026

Primary Completion

August 1, 2026

Study Completion

August 1, 2026

Last Updated

July 14, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations