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Not yet recruitingNCT07923409Updated Nov 6, 2026

Periodontal Status and Biomarkers in MASLD

An observational study in Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), sponsored by Recep Tayyip Erdogan University. Not yet recruiting. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Recep Tayyip Erdogan University · Observational

Updated Nov 6, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
66
Ages
18 Years to 65 Years
Sex
All
01

Study 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). 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.

02

Conditions studied

  • Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
03

In context

Lead sponsor

Recep Tayyip Erdogan University is the lead sponsor of 69 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Recep Tayyip Erdoğan University

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

  • A history of using medications associated with fatty liver diseases,
  • A history of other liver diseases, such as chronic , viral (serum-positive for hepatitis B surface antigen), 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).
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
66 participants (estimated)
Patient registry
No

Groups and cohorts

  • Group 1

    Patients with a diagnosis of MASLD but no evidence of significant liver fibrosis (F0-F1)

    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)

    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

    Other: measurement of periodontal parameters · Other: collection of GCF and serum samples

Interventions

  • Othermeasurement of periodontal parameters

    Baseline

  • Othercollection of GCF and serum samples

    baseline

06

What researchers measure

Primary outcomes

  1. Measurement of periodontal pocket depth

    The distance between the gingival margin and the base of the pocket will be measured.

    Time frame: baseline

  2. Measurement of clinical attachment loss

    The distance between the cemento-enamel junction and the base of the pocket will be measured.

    Time frame: 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.

    Time frame: baseline

07

Study locations

No study locations are listed for this record.

08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Feb 2027; primary completion for Feb 2028, 11 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 2, 2026
First posted
Nov 6, 2026
StartEst.
Feb 26, 2027
Primary completionEst.
Feb 6, 2028
CompletionEst.
Feb 26, 2028
Last update
Nov 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07923409
Lead sponsor
Recep Tayyip Erdogan University
Responsible party
Melek Beder (Doctor, Recep Tayyip Erdogan University) — Principal investigator
First posted
Nov 6, 2026
Start date
Feb 26, 2027 (estimated)
Primary completion
Feb 6, 2028 (estimated)
Completion
Feb 26, 2028 (estimated)
Last update
Nov 6, 2026

Study contacts

MELEK BEDER
Contact
melek.beder@erdogan.edu.tr
05347615837

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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