Metabolic Syndrome-Associated Periodontal Inflammatory Surface Area

NCT07354815 | Not Yet Recruiting DMC

• 1 other identifier: MetSPISA07/2025
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metabolic Syndrome (MetS); Periodontitis

Keywords

metabolic syndrome; periodontitis; periodontal inflammatory surface area

Outcome Measures

Primary Outcomes (1)

• Periodontal Inflammatory Surface Area (PISA) Calculation

  PISA is automatically obtained by transferring the bleeding on probing (BOP), clinical attachment loss (CAL) and gingival recession measured from 6 regions (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) of each tooth into a Microsoft Excel spreadsheet. Bleeding on Probing (BOP): Bleeding from the gingival tissue occurs as a result of light force applied to the periodontal pocket during probing. It is often an early indicator of gingival inflammation and is used to determine periodontal disease activity. Clinical Attachment Loss (CAL): This is the distance from the gingival margin to the cemento-cemental junction, measured with a periodontal probe. It refers to the loss of periodontal supporting tissues (periodontal ligament and alveolar bone) and is used to assess the severity of periodontal disease. Gingival Recession: This is the displacement of the gingival margin apically toward the cemento-cemental junction.

  Day 1

Secondary Outcomes (5)

• Clinical Periodontal Parameters (Plaque Index)

  Day 1

• Periodontal Clinical Parametres (Bleeding on Probing Index)

  Day 1

• Periodontal Clinical Parametres (Probing Pocket Depth)

  Day 1

• Periodontal Clinical Parametres (Clinical Attachment Loss)

  Day 1

• Sociodemographic Data

  Day 1

Other Outcomes (8)

• Fasting blood glucose

  Day 1

• Glycated Hemoglobin A1c

  Day 1

• Triglyceride

  Day 1

Study Arms (1)

Patients diagnosed with metabolic syndrome

Metabolic syndrome is diagnosed according to the National Cholesterol Education Program Adult Treatment Panel III (NCEP/ATP III) criteria. Diagnosis is made by meeting three of the following five criteria: waist circumference: ≥ 94 cm in men and ≥ 88 cm in women, blood pressure ≥ 130/85 mmHg or use of antihypertensive medication, fasting blood glucose ≥ 100 mg/dL or diagnosed type 2 diabetes, triglycerides ≥ 1.7 mmol/L, and HDL \< 1.29 mmol/L.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with metabolic syndrome who come to the Periodontology Clinic of Recep Tayyip Erdoğan University Faculty of Dentistry for routine periodontal treatment

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Recep Tayyip Erdogan University Training and Research Hospital: lead

Study Sites (1)

Department of Periodontology of the Faculty of Dentistry of Recep Tayyip Erdogan University

Rize, Rize Province, 53200, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum blood samples Routine blood tests will include fasting blood glucose, HbA1c, triglyceride, HDL, and hsCRP levels.

MeSH Terms

Conditions

Metabolic Syndrome; Periodontitis

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Oguz KOSE, Professor Dr.

CONTACT

+90 541 348 64 65; oguz.kose@erdogan.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: January 21, 2026
• Study Start: February 23, 2026
• Primary Completion (Estimated): May 25, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)