- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07666126
Evaluation of the Effect of Hyperuricemia on Alveolar Bone Loss
Evaluation of the Effect of Hyperuricemia on Alveolar Bone Loss and Oxidative Stress
Periodontitis is a multifactorial disease characterized by chronic inflammation of the gum tissue and alveolar bone destruction, and is known to be associated with various systemic diseases. Hyperuricemia, on the other hand, is a metabolic condition characterized by increased serum uric acid levels and can affect inflammation, oxidative stress, and bone metabolism. In recent years, the relationship between hyperuricemia and periodontal diseases has been increasingly investigated, but the biological mechanisms of this relationship have not yet been fully elucidated. Therefore, this study aimed to determine whether there is a relationship between hyperuricemia and periodontitis and to reveal the possible pathophysiological mechanisms of this relationship, which are shaped by inflammation, oxidative stress, and bone metabolism.
A total of 80 individuals aged 18-65 years will be included in this clinical observational study. The periodontal status of the participants will be assessed using clinical periodontal parameters such as probing pocket depth, clinical attachment loss, plaque index, gingival index, and bleeding on probing. Participants will be divided into four groups according to their periodontal status and the presence of hyperuricemia: individuals with periodontitis and hyperuricemia, individuals with periodontally healthy and hyperuricemia, individuals with periodontitis but without hyperuricemia, and individuals with periodontally healthy and without hyperuricemia. Gingival crevicular fluid and serum samples will be taken from the participants. In these samples, receptor-mediated nuclear factor kappa B ligand, osteoprotegerin, total antioxidant status, total oxidant status, oxidative stress index, interleukin-1 beta, interleukin-10, interleukin-18, and nucleotide-binding oligomerization domain-like receptor protein 3 levels will be analyzed. This study is considered unique because it examines the relationship between hyperuricemia and periodontitis by evaluating inflammation, oxidative stress, and bone metabolism parameters together.
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Hatice Yemenoglu
- Telefonnummer: +905052977517
- E-Mail: htcymnglu@hotmail.com
Studienorte
-
-
-
Rize, Türkei (türkiye), 53020
- Rekrutierung
- Recep Tayyip Erdogan University
-
Kontakt:
- Hatice Yemenoglu
- Telefonnummer: +904642220000
- E-Mail: htcymnglu@hotmail.com
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- Being between 18 and 65 years of age
- Being systemically healthy or diagnosed with hyperuricemia
- Having at least 20 natural teeth
- Being periodontally healthy or diagnosed with periodontitis
Exclusion Criteria:
- Diabetes, cardiovascular disease, osteoporosis, chronic kidney disease, metabolic syndrome, and obesity are systemic diseases that may affect purine metabolism.
- Smoking
- Pregnancy or lactation
- Having received periodontal treatment within the last 3-6 months
- Use of antibiotics, anti-inflammatory drugs, or uric acid-lowering drugs
- Presence of systemic diseases that may affect purine metabolism
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
Group 1: Individuals with periodontitis and hyperuricemia
|
Serum and GCF samples will be collected from participants in the first session
Periodontal clinical parameters will be measured from participants initially
|
|
Group 2: Periodontally healthy individuals with hyperuricemia
|
Serum and GCF samples will be collected from participants in the first session
Periodontal clinical parameters will be measured from participants initially
|
|
Group 3: Individuals with periodontitis but without hyperuricemia
|
Serum and GCF samples will be collected from participants in the first session
Periodontal clinical parameters will be measured from participants initially
|
|
Group 4: Periodontally healthy individuals without hyperuricemia
|
Serum and GCF samples will be collected from participants in the first session
Periodontal clinical parameters will be measured from participants initially
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Periodontal pocket depth
Zeitfenster: at baseline
|
The distance between the gingival margin and the base of the pocket will be measured in millimeters.
|
at baseline
|
|
clinical attachment loss
Zeitfenster: at baseline
|
The distance between the enamel-cementum junction and the base of the pocket will be measured in millimeters.
|
at baseline
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Level of interleukin-1 beta
Zeitfenster: at baseline
|
Interleukin-1 beta levels will be determined from gingival crevicular fluid and serum samples using the ELISA method.
|
at baseline
|
|
Level of interleukin-10
Zeitfenster: at baseline
|
Interleukin-10 levels will be determined from gingival crevicular fluid and serum samples using the ELISA method.
|
at baseline
|
|
Level of interleukin-18
Zeitfenster: at baseline
|
Interleukin-18 levels will be determined from gingival crevicular fluid and serum samples using the ELISA method.
|
at baseline
|
Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2025/302
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .