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Metabolic Syndrome-Associated Periodontal Inflammatory Surface Area

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07354815
Enrollment
100
Registered
2026-01-21
Start date
2026-02-23
Completion date
2026-06-30
Last updated
2026-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome (MetS), Periodontitis

Keywords

metabolic syndrome, periodontitis, periodontal inflammatory surface area

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.

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.

Interventions

None listed

Sponsors

Recep Tayyip Erdogan University Training and Research Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Periodontal Inflammatory Surface Area (PISA) CalculationDay 1PISA 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.

Secondary

MeasureTime frameDescription
Clinical Periodontal Parameters (Plaque Index)Day 1Plaque Index (PI) (Silness and Löe, 1964) This index is used to evaluate the amount of dental plaque accumulation on tooth surfaces. Each tooth's four surfaces (buccal, lingual, mesial, distal) are examined using a probe or visually. Each surface is scored from 0 to 3. The average score is calculated for each tooth. The overall plaque index is obtained by averaging the scores from all examined teeth. Score Description 0 No plaque. 1. No visible plaque, but a slight film of plaque is detected when a probe is run along the gingival margin. 2. Visible plaque along the gingival margin, forming a continuous band. 3. Abundant plaque covering the gingival area and extending toward the middle of the tooth surface, including the interproximal spaces.
Periodontal Clinical Parametres (Bleeding on Probing Index)Day 1This index is used to assess the presence and severity of gingival inflammation by observing bleeding after gentle pressure is applied to the gingival sulcus using a periodontal probe. A thin periodontal probe is gently inserted into the gingival sulcus with light pressure (approximately 20-25 grams). Bleeding occurring within 10-30 seconds is observed. Each measurement site is recorded as either "bleeding present" or "bleeding absent." Presence of bleeding is an early and sensitive indicator of gingival inflammation. Score Description: 0 No bleeding 1 Bleeding present (mild or severe)
Periodontal Clinical Parametres (Probing Pocket Depth)Day 1Using a Williams periodontal probe, the distance between the gingival margin and the base of the periodontal pocket is measured in millimeters at six sites per tooth: mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual. All teeth are measured. The values obtained from each site are summed and then divided by the total number of sites measured. This gives the average probing depth for the individual. Measurement Interpretation 1-3 mm Healthy sulcus 4-5 mm Shallow to moderate pocket ≥6 mm Deep periodontal pocket (advanced disease)
Periodontal Clinical Parametres (Clinical Attachment Loss)Day 1Using a Williams periodontal probe, the distance between the enamel-cementum junction and the base of the periodontal pocket is measured in millimeters at six sites per tooth: mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual. All teeth are measured. The values obtained from each site are summed and then divided by the total number of sites measured. This gives the average probing depth for the individual. CAL Value Interpretation 0-1 mm Healthy / minimal loss 2-3 mm Mild attachment loss 4-5 mm Moderate attachment loss ≥6 mm Severe attachment loss
Sociodemographic DataDay 1Sociodemographic data, including patients' age, gender, smoking, socioeconomic status, education level, and how many times a day they brush their teeth, will be noted.

Countries

Turkey (Türkiye)

Contacts

CONTACTOguz KOSE, Professor Dr.
oguz.kose@erdogan.edu.tr+90 541 348 64 65

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026