NCT07923409Toborzás még nem indult
Periodontal Status and Biomarkers in MASLD
Investigation of Periodontal Status and Vitamin D, Oxidative Stress, RANKL, and OPG Levels in Patients With MASLD
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. nov. 6.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 66 (tervezett)
- Első benyújtás
- 2026. nov. 2.
- Kezdés
- 2027. febr. 26.
- Elsődleges befejezés
- 2028. febr. 6.
- Fő szponzor
- Recep Tayyip Erdogan University
- Betegségek
- Zsírmáj (MASLD/MASH)
- NCT-szám
- NCT07923409
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 66
- 2027. febr. 26. és az elsődleges befejezés (2028. febr. 6.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Use of antibiotics or anti-inflammatory drugs within the 30 days prior to study enrollment,
Más betegség
- 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),
Laborértékek
- 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,
Egyéb
- Pregnancy or lactation,
- Receipt of periodontal treatment within the last 6 months,
- Smoking or alcohol consumption (>20 g/day).
Kiket keres a vizsgálat
- 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).
Életkor a regiszterben: 18 év – 65 év · Nem: nők és férfiak · Egészséges önkénteseket is fogad
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.