- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Hatice Yemenoglu
- Numéro de téléphone: +905052977517
- E-mail: htcymnglu@hotmail.com
Lieux d'étude
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Rize, Turquie (Türkiye), 53020
- Recrutement
- Recep Tayyip Erdogan University
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Contact:
- Hatice Yemenoglu
- Numéro de téléphone: +904642220000
- E-mail: htcymnglu@hotmail.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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
|
|
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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Periodontal pocket depth
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Level of interleukin-1 beta
Délai: 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
Délai: 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
Délai: at baseline
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Interleukin-18 levels will be determined from gingival crevicular fluid and serum samples using the ELISA method.
|
at baseline
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2025/302
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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