Metabolic Syndrome (MetS)NCT07354815
Metabolic Syndrome-Associated Periodontal Inflammatory Surface Area
An observational study of Metabolic Syndrome (MetS) and Periodontitis, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Metabolic Syndrome (MetS), Periodontitis
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Feb 2026to 30 Jun 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- Patients with active infectious disease,
- Those taking medications that may affect periodontal tissues,
- Those who did not sign the informed consent form.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Department of Periodontology of the Faculty of Dentistry of Recep Tayyip Erdogan University
Rize, Rize Province, 53200
RTEU Faculty of Dentistry, Department of Periodontology, +90 464 222 00 00, dis@erdogan.edu.tr
About this study
Official title: 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.
Read the 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.
- Conditions
- Metabolic Syndrome (MetS), Periodontitis
- Keywords
- metabolic syndrome, periodontitis, periodontal inflammatory surface area
- Medical subject headings
- Metabolic Syndrome, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (5)
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.
- No visible plaque, but a slight film of plaque is detected when a probe is run along the gingival margin.
- Visible plaque along the gingival margin, forming a continuous band.
- Abundant plaque covering the gingival area and extending toward the middle of the tooth surface, including the interproximal spaces.
Measured: Day 1
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)
Measured: Day 1
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)
Measured: Day 1
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
Measured: Day 1
Sociodemographic Data
Sociodemographic data, including patients' age, gender, smoking, socioeconomic status, education level, and how many times a day they brush their teeth, will be noted.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start23 Feb 2026 (estimated)
- Primary completion25 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Syndrome (MetS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek KARADOĞAN, Recep Tayyip Erdogan University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07354815
- Sponsor's protocol ID
- MetSPISA07/2025
- Status last verified
- Jan 2026
- First submitted
- 28 Aug 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Level of Correlation Between Periodontal Inflammatory Surface Area and Metabolic Syndrome-Associated Periodontal Tissue Destruction
- ClinicalTrials.gov ID
- NCT07354815
- Acronym / sponsor ID
- MetSPISA07/2025
- Conditions
- Metabolic Syndrome (MetS), Periodontitis
- Keywords
- metabolic syndrome, periodontitis, periodontal inflammatory surface area
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- 23 Feb 2026 (estimated)
- Primary completion
- 25 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (3 listed)
- Patients with active infectious disease,
- Those taking medications that may affect periodontal tissues,
- Those who did not sign the informed consent form.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Periodontal Inflammatory Surface Area (PISA) Calculation
Time frame: Day 1
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome (MetS) and Periodontitis, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oguz KOSE, Professor Dr. (+90 541 348 64 65, oguz.kose@erdogan.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periodontal Inflammatory Surface Area (PISA) Calculation (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.