Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)NCT07923409
Periodontal Status and Biomarkers in MASLD
An observational study of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), run by Recep Tayyip Erdogan University.
Trial summary
This study is designed as a prospective, observational research project conducted in collaboration between the Department of Periodontology at the Faculty of Dentistry and the Division of Gastroenterology at the Faculty of Medicine, Recep Tayyip Erdoğan University (RTEÜ). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
- What is being tested?
- measurement of periodontal parameters and collection of GCF and serum samples
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 26 Feb 2027to 26 Feb 2028
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Recep Tayyip Erdoğan University
Who may be able to join
- Being between 18 and 65 years of age,
- Having a diagnosis of periodontal health, gingivitis, or periodontal disease,
- Possessing at least 20 natural teeth,
- Having a diagnosis of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) (defined as hepatic steatosis confirmed by ultrasound imaging or histology, in the presence of metabolic dysfunctions such as abdominal obesity, dyslipidemia, hyperglycemia, or metabolic syndrome),
- For the control group, being classified as a healthy individual (criteria include the absence of hepatic steatosis, failure to meet the diagnostic criteria for MASLD, and the absence of chronic liver disease).
Who cannot join
- A history of using medications associated with fatty liver diseases,
- A history of other liver diseases, such as chronic hepatitis C, viral hepatitis B (serum-positive for hepatitis B surface antigen), autoimmune hepatitis, primary biliary cirrhosis, sclerosing cholangitis, hemochromatosis, alpha-1 antitrypsin deficiency, Wilson's disease, or liver damage resulting from substance abuse,
- Use of antibiotics or anti-inflammatory drugs within the 30 days prior to study enrollment,
- Cardiac conditions, such as the presence of a pacemaker or heart failure,
- Presence of systemic diseases (e.g., rheumatoid arthritis),
- Pregnancy or lactation,
- Receipt of periodontal treatment within the last 6 months,
- Smoking or alcohol consumption (>20 g/day).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Investigation of Periodontal Status and Vitamin D, Oxidative Stress, RANKL, and OPG Levels in Patients With MASLD
This study is designed as a prospective, observational research project conducted in collaboration between the Department of Periodontology at the Faculty of Dentistry and the Division of Gastroenterology at the Faculty of Medicine, Recep Tayyip Erdoğan University (RTEÜ). The study will include volunteers aged 18-65 who have a confirmed diagnosis of MASLD (metabolic dysfunction-associated steatotic liver disease) and have been referred from the Gastroenterology Clinic to the Periodontology Clinic. All participants will be informed about the study, and written informed consent will be obtained.
For all natural teeth present in the mouths of the patients in the study groups, measurements of probing pocket depth, clinical attachment loss, plaque index, gingival index, and bleeding index will be recorded, and gingival crevicular fluid (GCF) samples will be collected. GCF samples will be obtained from the four sites with the deepest periodontal pockets using specially prepared paper strips. Subsequently, nursing staff at the RTEÜ Faculty of Dentistry will collect 5 ml of venous blood from each patient-following a 15-20 minute rest period-between 08:00 and 10:00 AM. The blood samples will be centrifuged (4000 rpm for 10 minutes) and stored at -80°C at the faculty until the day of analysis. The collection of serum and GCF samples from the study participants involves non-invasive procedures that do not require anesthesia.
Levels of 25(OH)D3 in the GCF and serum samples will be determined using the ELISA method. Total antioxidant capacity (TAC) and total oxidant capacity (TOC) will be measured via colorimetric methods, and the oxidative stress index (OSI) will be calculated using the TOC/TAC ratio. RANKL and OPG levels will be analyzed exclusively in serum samples using the ELISA method.
- Being tested
- measurement of periodontal parameters, collection of GCF and serum samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurement of periodontal parametersOther
Baseline
collection of GCF and serum samplesOther
baseline
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients with a diagnosis of MASLD but no evidence of significant liver fibrosis (F0-F1) Receives: Other: measurement of periodontal parameters; Other: collection of GCF and serum samples | |
| Group 2 | Patients with a diagnosis of MASLD and evidence of significant liver fibrosis (F≥2) Receives: Other: measurement of periodontal parameters; Other: collection of GCF and serum samples | |
| Group 3 | Systemically healthy control group with no evidence of hepatic steatosis or MASLD based on imaging and clinical assessment Receives: Other: measurement of periodontal parameters; Other: collection of GCF and serum samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of periodontal pocket depth
The distance between the gingival margin and the base of the pocket will be measured.
Measured: baseline
Measurement of clinical attachment loss
The distance between the cemento-enamel junction and the base of the pocket will be measured.
Measured: baseline
Secondary outcomes (1)
Measurement of 25(OH)D3 levels in gingival crevicular fluid
The level of 25(OH)D3 in the gingival crevicular fluid will be determined using the ELISA method.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start26 Feb 2027 (estimated)
- Primary completion6 Feb 2028 (estimated)
- Study completion26 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melek Beder, Recep Tayyip Erdogan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07923409
- Sponsor's protocol ID
- Recep Tayyip Erdogan Uni.
- Status last verified
- Nov 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Periodontal Status and Vitamin D, Oxidative Stress, RANKL, and OPG Levels in Patients With MASLD
- ClinicalTrials.gov ID
- NCT07923409
- Acronym / sponsor ID
- Recep Tayyip Erdogan Uni.
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Recep Tayyip Erdogan UniversityUniversity, hospital or other
- Study start
- 26 Feb 2027 (estimated)
- Primary completion
- 6 Feb 2028 (estimated)
- Study completion
- 26 Feb 2028 (estimated)
- First posted
- 6 Nov 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 is designed as a prospective, observational research project conducted in collaboration between the Department of Periodontology at the Faculty of Dentistry and the Division of Gastroenterology at the Faculty of Medicine, Recep Tayyip Erdoğan University (RTEÜ). The study will include volunteers aged 18-65 who have a confirmed diagnosis of MASLD (metabolic dysfunction-associated steatotic liver disease) and have been referred from the Gastroenterology Clinic to the Periodontology Clinic. All participants will be informed about the study, and written informed consent will be obtained.
For all natural teeth present in the mouths of the patients in the study groups, measurements of probing pocket depth, clinical attachment loss, plaque index, gingival index, and bleeding index will be recorded, and gingival crevicular fluid (GCF) samples will be collected. GCF samples will be obtained from the four sites with the deepest periodontal pockets using specially prepared paper strips. Subsequently, nursing staff at the RTEÜ Faculty of Dentistry will collect 5 ml of venous blood from each patient-following a 15-20 minute rest period-between 08:00 and 10:00 AM. The blood samples will be centrifuged (4000 rpm for 10 minutes) and stored at -80°C at the faculty until the day of analysis. The collection of serum and GCF samples from the study participants involves non-invasive procedures that do not require anesthesia.
Levels of 25(OH)D3 in the GCF and serum samples will be determined using the ELISA method. Total antioxidant capacity (TAC) and total oxidant capacity (TOC) will be measured via colorimetric methods, and the oxidative stress index (OSI) will be calculated using the TOC/TAC ratio. RANKL and OPG levels will be analyzed exclusively in serum samples using the ELISA method.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: measurement of periodontal parameters, Other: collection of GCF and serum samplesPatients with a diagnosis of MASLD but no evidence of significant liver fibrosis (F0-F1) |
| Group 2 | – | Other: measurement of periodontal parameters, Other: collection of GCF and serum samplesPatients with a diagnosis of MASLD and evidence of significant liver fibrosis (F≥2) |
| Group 3 | – | Other: measurement of periodontal parameters, Other: collection of GCF and serum samplesSystemically healthy control group with no evidence of hepatic steatosis or MASLD based on imaging and clinical assessment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Recep Tayyip Erdoğan University
Key inclusion criteria (5 listed)
- Being between 18 and 65 years of age,
- Having a diagnosis of periodontal health, gingivitis, or periodontal disease,
- Possessing at least 20 natural teeth,
- Having a diagnosis of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) (defined as hepatic steatosis confirmed by ultrasound imaging or histology, in the presence of metabolic dysfunctions such as abdominal obesity, dyslipidemia, hyperglycemia, or metabolic syndrome),
- For the control group, being classified as a healthy individual (criteria include the absence of hepatic steatosis, failure to meet the diagnostic criteria for MASLD, and the absence of chronic liver disease).
Key exclusion criteria (8 listed)
- A history of using medications associated with fatty liver diseases,
- A history of other liver diseases, such as chronic hepatitis C, viral hepatitis B (serum-positive for hepatitis B surface antigen), autoimmune hepatitis, primary biliary cirrhosis, sclerosing cholangitis, hemochromatosis, alpha-1 antitrypsin deficiency, Wilson's disease, or liver damage resulting from substance abuse,
- Use of antibiotics or anti-inflammatory drugs within the 30 days prior to study enrollment,
- Cardiac conditions, such as the presence of a pacemaker or heart failure,
- Presence of systemic diseases (e.g., rheumatoid arthritis),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| measurement of periodontal parametersBaseline | Other | Group 1, Group 2, Group 3 |
| collection of GCF and serum samplesbaseline | Other | Group 1, Group 2, Group 3 |
Primary outcome
Measurement of periodontal pocket depth
Time frame: baseline
The distance between the gingival margin and the base of the pocket will be measured.
Measurement of clinical attachment loss
Time frame: baseline
The distance between the cemento-enamel junction and the base of the pocket will be measured.
1 secondary outcome
Measurement of 25(OH)D3 levels in gingival crevicular fluid
Time frame: baseline
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 6 Nov 2026.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), run by Recep Tayyip Erdogan University.
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 5 inclusion and 8 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 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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 MELEK BEDER (05347615837, melek.beder@erdogan.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of periodontal pocket depth (time frame: baseline). The study lists 2 primary outcomes in all. 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 6 Nov 2026.