Metabolic Syndrome-Associated Periodontal Inflammatory Surface Area

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorRecep Tayyip Erdogan University Training and Research Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients with active infectious disease,

Those taking medications that may affect periodontal tissues,

Those who did not sign the informed consent form.

Trial population

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

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 1 trial group
Group A: Patients diagnosed with metabolic syndrome

Trial outcomes

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.

Time frame
Day 1

Secondary outcomes

1

Clinical Periodontal Parameters (Plaque Index)

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. 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.

Time frame
Day 1
2

Periodontal Clinical Parametres (Bleeding on Probing Index)

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)

Time frame
Day 1
3

Periodontal Clinical Parametres (Probing Pocket Depth)

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)

Time frame
Day 1
4

Periodontal Clinical Parametres (Clinical Attachment Loss)

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

Time frame
Day 1

Other outcomes

1

Fasting blood glucose

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.

Time frame
Day 1
2

Glycated Hemoglobin A1c

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.

Time frame
Day 1
3

Triglyceride

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.

Time frame
Day 1
4

HDL (High-Density Lipoprotein)

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.

Time frame
Day 1

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: