Impact of Periodontal Intervention on Vascular Dysfunction
Periodontal Intervention Improves Vascular Function Among Chinese Prehypertensive Adults With Periodontitis
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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Guangdong
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Guangzhou、Guangdong、中国、510080
- The First Affiliated Hospital, Sun Yat-sen University
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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他の：Periodontal care
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実験的：One-Stage Full-Mouth Disinfection
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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Change from Baseline in the Number of Endothelial Microparticle at 6 months
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Brachia-ankle Pulse Wave Velocity(baPWV)
時間枠：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)
時間枠：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
時間枠：baseline
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baseline
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Changes in Malondialdehyde(MDA) and Superoxide Dismutase(SOD)
時間枠：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)
時間枠：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)
時間枠：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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協力者と研究者
捜査官
- スタディディレクター：Jun Ying Yang, Master、First Affiliated Hospital, Sun Yat-Sen University
- スタディチェア：Jun Tao, M.D.,phD.、First Affiliated Hospital, Sun Yat-Sen University
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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