Impact of Periodontal Intervention on Vascular Dysfunction
Periodontal Intervention Improves Vascular Function Among Chinese Prehypertensive Adults With Periodontitis
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
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Guangdong
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Guangzhou, Guangdong, Kina, 510080
- The First Affiliated Hospital, Sun Yat-sen University
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Annen: Periodontal care
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Eksperimentell: One-Stage Full-Mouth Disinfection
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Change from Baseline in the Number of Endothelial Microparticle at 6 months
Tidsramme: 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
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Change from Baseline in the Blood Pressure at 6 months
Tidsramme: 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
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Brachia-ankle Pulse Wave Velocity(baPWV)
Tidsramme: 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
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Changes in high-sensitivity C-Reactive Protein(hs-CRP) and Interleukin-6(IL-6)
Tidsramme: Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy
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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
Tidsramme: baseline
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baseline
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Changes in Malondialdehyde(MDA) and Superoxide Dismutase(SOD)
Tidsramme: 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
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Change in Periodontal Inflamed Surface Area(PISA)
Tidsramme: Baseline; 3 months post periodontal therapy; 6 months post periodontal therapy
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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.
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Baseline; 3 months post periodontal therapy; 6 months post periodontal therapy
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Change in Endothelium-dependent Brachial Artery Flow-mediated Dilation(FMD)
Tidsramme: 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
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Samarbeidspartnere og etterforskere
Etterforskere
- Studieleder: Jun Ying Yang, Master, First Affiliated Hospital, Sun Yat-Sen University
- Studiestol: Jun Tao, M.D.,phD., First Affiliated Hospital, Sun Yat-Sen University
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 20130718emp
- 31270992 (Registeridentifikator: National Natural Science Foundation of China)
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