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Not yet recruiting NCT07354815

Metabolic Syndrome-Associated Periodontal Inflammatory Surface Area

— Observational Metabolic Syndrome (MetS) Periodontitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Metabolic Syndrome (MetS), Periodontitis. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Determination of the Level of Correlation Between Periodontal Inflammatory Surface Area and Metabolic Syndrome-Associated Periodontal Tissue Destruction

Overview

This study aims to examine the potential of metabolic syndrome (MetS), a systemic, inflammatory disease, to influence the relationship between periodontal inflammatory surface area (PISA) and diabetes and obesity parameters. The primary question addressed by the study is: Can PISA be used as a significant parameter in the relationship between periodontal disease and MetS? In this context, the relationship between PISA and periodontal clinical parameters and serum parameters directly related to the diagnosis of MetS will be examined.

Detailed description

This study aims to investigate the potential of metabolic syndrome (MetS), a systemic and inflammatory disease, to influence the relationship between periodontal inflammatory surface area (PISA) and diabetes and obesity parameters. Our hypothesis will test whether PISA can be used as a significant parameter in the relationship between periodontal disease and MetS. This cross-sectional study will examine the relationship between PISA and other periodontal clinical parameters (plaque index (PI), bleeding on probing (BPO), probing pocket depth (SCD), clinical attachment loss (CAL)), serum HbA1c, fasting blood glucose, lipid profile (HDL and triglyceride levels), body mass index (BMI), and hsCRP, which are directly related to MetS diagnosis, in patients with MetS.

Primary outcome measures

  • Periodontal Inflammatory Surface Area (PISA) Calculation [Time frame: Day 1]
Secondary outcome measures (5)
  • Clinical Periodontal Parameters (Plaque Index) [Time frame: Day 1]
  • Periodontal Clinical Parametres (Bleeding on Probing Index) [Time frame: Day 1]
  • Periodontal Clinical Parametres (Probing Pocket Depth) [Time frame: Day 1]
  • Periodontal Clinical Parametres (Clinical Attachment Loss) [Time frame: Day 1]
  • Sociodemographic Data [Time frame: Day 1]

Eligibility criteria

Inclusion criteria

  • Being between 18 and 65 years of age
  • Presence of at least three of the following parameters: (For MetS diagnosis) Waist circumference: ≥ 94 cm for men, ≥ 88 cm for women Blood pressure ≥ 130/85 mmHg or taking antihypertensive medication Fasting blood glucose ≥ 100 mg/dl or diagnosed with Type 2 Diabetes Triglycerides ≥ 1.7 mmol/L HDL < 1.29 mmol/L
  • Having at least 20 teeth
  • Not having received periodontal therapy in the last 6 months
  • Not having taken antibiotics, steroids, and/or nonsteroidal anti-inflammatory drugs in the last 3 weeks
  • Not having any autoimmune disease, osteoporosis, or cancer
  • Not taking immunosuppressive medications, oral contraceptives, Not taking bisphosphonates
  • Not being pregnant
  • Not having an active infectious disease (acute hepatitis, tuberculosis, AIDS)
  • Not taking chronic medications that affect periodontal tissues (cyclosporine A, phenytoin)
  • Not taking antioxidant supplements in the last 6 months

Exclusion criteria

  • Patients with active infectious disease,
  • Those taking medications that may affect periodontal tissues,
  • Those who did not sign the informed consent form.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Turkey (Türkiye) · 1 center
  • Department of Periodontology of the Faculty of Dentistry of Recep Tayyip Erdogan Universit — Rize

Identifiers

NCT: NCT07354815 · MetSPISA07/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗