- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01917292
Impact of Periodontal Intervention on Vascular Dysfunction
Periodontal Intervention Improves Vascular Function Among Chinese Prehypertensive Adults With Periodontitis
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Periodontitis is one of the low-grade chronic diseases, and it is the principal cause of tooth loss among middle-aged and elderly. Recently, epidemiological data indicate that patients with periodontitis are associated with increases in blood pressure levels and hypertension prevalence. Furthermore, studies from cross-sectional investigations demonstrate that hypertensive patients with periodontitis may enhance the risk and degree of vascular damage. Therefore, periodontal therapy is a novel therapeutic strategy to prevent the occurrence of BP elevation and retard the development vascular injury.
The term "prehypertension" indicates those with BPs ranging from 120 to 139 mm Hg systolic and/or 80 to 89 mm Hg diastolic blood pressure. Accumulating evidence suggests that subjects with prehypertension is associated with higher incidence of atherosclerotic vascular disease. However, until now there are no available data to investigate the influence of periodontitis on prehypertension and whether periodontal intervention may reduce the BP rise in subjects with prehypertension and improve the vascular function. We hypothesized that periodontitis leads to elevation in BP and periodontal therapy improves vascular function in subjects with prehypertension. To address these assumptions, The present study is designed to study the effect of periodontal intervention on blood pressure and vascular function and inflammatory biomarkers among Chinese prehypertensive adults with moderate to severe periodontal disease, and determine whether intensive periodontal therapy improves these measures over a 6-month follow-up period.
Type d'étude
Inscription (Réel)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
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-
Guangdong
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Guangzhou, Guangdong, Chine, 510080
- The First Affiliated Hospital, Sun Yat-sen University
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Subjects must be 18 years of age or older
- Moderate to severe generalized periodontitis(probing pocket depths of >6 mm and Marginal alveolar bone loss of >30%) with 50% or more of their teeth affected
- Have at least 16 natural teeth excluding third molars
- BPs ranging from 120 to 139 mm Hg systolic and/or 80 to 89 mm Hg diastolic blood pressure
- Provide informed consent and willingness to cooperate with the study protocol
Exclusion Criteria:
- History of antibiotic use in the previous three months
- Pregnant or lactating females
- Systemic diseases such as diabetes, HIV/AIDS, liver disease, chronic renal failure, tuberculosis, and autoimmune diseases
- Medical history of cardiovascular disease: Acute myocardial infarct, stable angina, unstable angina, heart failure, atrial fibrillation, atrioventricular blockade, peripheral vascular disease, cerebrovascular accident, hypertension
- Patients who received periodontal treatment within the last 6 months
- Patients who require antibiotic prophylaxis before examination or treatment
- Patients with mental retardation and dementia
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Autre: Periodontal care
|
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Expérimental: One-Stage Full-Mouth Disinfection
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|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Change from Baseline in the Number of Endothelial Microparticle at 6 months
Délai: Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy
|
Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy
|
Change from Baseline in the Blood Pressure at 6 months
Délai: Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy
|
Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change in Brachia-ankle Pulse Wave Velocity(baPWV)
Délai: Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy
|
Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy
|
|
Changes in high-sensitivity C-Reactive Protein(hs-CRP) and Interleukin-6(IL-6)
Délai: Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy
|
Compare the changes of traditional inflammatory biomarkers:hs-CRP and IL-6 over a 6-month follow-up period.
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Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy
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Expression of the Long non-protein-coding RNA(lncRNA) and microRNA
Délai: baseline
|
baseline
|
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Changes in Malondialdehyde(MDA) and Superoxide Dismutase(SOD)
Délai: Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy
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Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy
|
|
Change in Periodontal Inflamed Surface Area(PISA)
Délai: Baseline; 3 months post periodontal therapy; 6 months post periodontal therapy
|
Bleeding on probing(BOP), clinical attachment loss (CAL) and gingival recession(GR) are measured to calculate the PISA.The PISA reflects the surface area of bleeding pocket epithelium in square millimetres.
|
Baseline; 3 months post periodontal therapy; 6 months post periodontal therapy
|
Change in Endothelium-dependent Brachial Artery Flow-mediated Dilation(FMD)
Délai: Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy
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Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy
|
Collaborateurs et enquêteurs
Les enquêteurs
- Directeur d'études: Jun Ying Yang, Master, First Affiliated Hospital, Sun Yat-Sen University
- Chaise d'étude: Jun Tao, M.D.,phD., First Affiliated Hospital, Sun Yat-Sen University
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
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
- 20130718emp
- 31270992 (Identificateur de registre: National Natural Science Foundation of China)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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