- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01917292
Impact of Periodontal Intervention on Vascular Dysfunction
Periodontal Intervention Improves Vascular Function Among Chinese Prehypertensive Adults With Periodontitis
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Guangdong
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Guangzhou, Guangdong, 중국, 510080
- The First Affiliated Hospital, Sun Yat-sen University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: Periodontal care
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실험적: One-Stage Full-Mouth Disinfection
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Change from Baseline in the Number of Endothelial Microparticle at 6 months
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Brachia-ankle Pulse Wave Velocity(baPWV)
기간: 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)
기간: 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
기간: baseline
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baseline
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Changes in Malondialdehyde(MDA) and Superoxide Dismutase(SOD)
기간: 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)
기간: 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)
기간: 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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공동 작업자 및 조사자
수사관
- 연구 책임자: Jun Ying Yang, Master, First Affiliated Hospital, Sun Yat-Sen University
- 연구 의자: Jun Tao, M.D.,phD., First Affiliated Hospital, Sun Yat-Sen University
간행물 및 유용한 링크
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연구 주요 날짜
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기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
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처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
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추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .