- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Hatice Yemenoglu
- Numero di telefono: +905052977517
- Email: htcymnglu@hotmail.com
Luoghi di studio
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Rize, Turchia (Türkiye), 53020
- Reclutamento
- Recep Tayyip Erdogan University
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Contatto:
- Hatice Yemenoglu
- Numero di telefono: +904642220000
- Email: htcymnglu@hotmail.com
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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Group 1: Individuals with periodontitis and hyperuricemia
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Serum and GCF samples will be collected from participants in the first session
Periodontal clinical parameters will be measured from participants initially
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Group 2: Periodontally healthy individuals with hyperuricemia
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Serum and GCF samples will be collected from participants in the first session
Periodontal clinical parameters will be measured from participants initially
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Group 3: Individuals with periodontitis but without hyperuricemia
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Serum and GCF samples will be collected from participants in the first session
Periodontal clinical parameters will be measured from participants initially
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Group 4: Periodontally healthy individuals without hyperuricemia
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Serum and GCF samples will be collected from participants in the first session
Periodontal clinical parameters will be measured from participants initially
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Periodontal pocket depth
Lasso di tempo: at baseline
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The distance between the gingival margin and the base of the pocket will be measured in millimeters.
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at baseline
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clinical attachment loss
Lasso di tempo: at baseline
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The distance between the enamel-cementum junction and the base of the pocket will be measured in millimeters.
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at baseline
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Level of interleukin-1 beta
Lasso di tempo: at baseline
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Interleukin-1 beta levels will be determined from gingival crevicular fluid and serum samples using the ELISA method.
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at baseline
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Level of interleukin-10
Lasso di tempo: at baseline
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Interleukin-10 levels will be determined from gingival crevicular fluid and serum samples using the ELISA method.
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at baseline
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Level of interleukin-18
Lasso di tempo: at baseline
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Interleukin-18 levels will be determined from gingival crevicular fluid and serum samples using the ELISA method.
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at baseline
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Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2025/302
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .