- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07354815
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
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Oguz KOSE, Professor Dr.
- Phone Number: +90 541 348 64 65
- Email: oguz.kose@erdogan.edu.tr
Study Locations
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Rize Province
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Rize, Rize Province, Turkey (Türkiye), 53200
- Department of Periodontology of the Faculty of Dentistry of Recep Tayyip Erdogan University
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Contact:
- RTEU Faculty of Dentistry, Department of Periodontology
- Phone Number: +90 464 222 00 00
- Email: dis@erdogan.edu.tr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Periodontal Inflammatory Surface Area (PISA) Calculation
Time Frame: Day 1
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Clinical Periodontal Parameters (Plaque Index)
Time Frame: Day 1
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Plaque 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.
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Day 1
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Periodontal Clinical Parametres (Probing Pocket Depth)
Time Frame: Day 1
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Using 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) |
Day 1
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Periodontal Clinical Parametres (Clinical Attachment Loss)
Time Frame: Day 1
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Using 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 |
Day 1
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Periodontal Clinical Parametres (Bleeding on Probing Index)
Time Frame: Day 1
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This 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) |
Day 1
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Sociodemographic Data
Time Frame: Day 1
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Sociodemographic data, including patients' age, gender, smoking, socioeconomic status, education level, and how many times a day they brush their teeth, will be noted.
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Day 1
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Fasting blood glucose
Time Frame: Day 1
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Fasting Blood Glucose: The plasma glucose concentration measured after at least 8 hours of caloric restriction.
It is a fundamental biochemical parameter for assessing glycemic status and diagnosing diabetes.
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Day 1
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Glycated Hemoglobin A1c
Time Frame: Day 1
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HbA1c (Glycated Hemoglobin A1c): A stable complex formed by the non-enzymatic covalent binding of glucose to the β-chain of hemoglobin, reflecting the average blood glucose level over the lifespan of erythrocytes (approximately 120 days).
It is considered a gold standard indicator of long-term glycemic control.
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Day 1
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Triglyceride
Time Frame: Day 1
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Triglyceride: A neutral lipid composed of three fatty acids esterified to a glycerol backbone.
It is primarily transported in plasma by VLDL and chylomicrons and serves as a biomarker of dyslipidemia and cardiometabolic risk.
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Day 1
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HDL (High-Density Lipoprotein)
Time Frame: Day 1
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HDL (High-Density Lipoprotein): Lipoprotein particles of high density that play a central role in reverse cholesterol transport, shuttling cholesterol from peripheral tissues to the liver for excretion.
They exhibit anti-atherogenic, anti-inflammatory, and antioxidant properties.
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Day 1
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hsCRP (High-Sensitivity C-Reactive Protein)
Time Frame: Day 1
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hsCRP (High-Sensitivity C-Reactive Protein): The low-level concentrations of the liver-derived acute-phase reactant CRP, measured by high-sensitivity immunoturbidimetric or nephelometric assays.
It serves as a biomarker of subclinical inflammation and cardiovascular risk.
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Day 1
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Waist Circumference
Time Frame: Day 1
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Waist Circumference: The individual stands upright.
A tape measure is taken horizontally at the narrowest point of the waist (usually between the bottom of the ribs and the top of the hipbone).
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Day 1
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Height
Time Frame: Day 1
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Height: a measure of vertical distance, vertical dimension, or vertical position.
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Day 1
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Weight
Time Frame: Day 1
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Weight is the gravitational force exerted on an object.
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Day 1
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MetSPISA07/2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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