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NCT07923409Not yet recruiting

Periodontal Status and Biomarkers in MASLD

Investigation of Periodontal Status and Vitamin D, Oxidative Stress, RANKL, and OPG Levels in Patients With MASLD

Source: ClinicalTrials.gov · Last updated 6 Nov 2026

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Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
66 (estimated)
First submitted
2 Nov 2026
Start date
26 Feb 2027
Primary completion date
6 Feb 2028
Lead sponsor
Recep Tayyip Erdogan University
NCT number
NCT07923409

What you commit to

  • Study type: Observational
  • Planned participants: 66
  • From 26 Feb 2027 to the primary completion date, 6 Feb 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Use of antibiotics or anti-inflammatory drugs within the 30 days prior to study enrollment,

Other illness

  • A history of using medications associated with fatty liver diseases,
  • Cardiac conditions, such as the presence of a pacemaker or heart failure,
  • Presence of systemic diseases (e.g., rheumatoid arthritis),

Lab values

  • 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,

Other

  • Pregnancy or lactation,
  • Receipt of periodontal treatment within the last 6 months,
  • Smoking or alcohol consumption (>20 g/day).

Who the study is looking for

  • 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).

Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.