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| ID | Type | Description | Link |
|---|---|---|---|
| 31270992 | Registry Identifier | National Natural Science Foundation of China |
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The purpose of this study is to determine the effect of periodontal intervention on vascular dysfunction among Chinese prehypertensive adults with moderate to severe periodontal disease.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Periodontal care | Other |
| |
| One-Stage Full-Mouth Disinfection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| One-Stage Full-Mouth Disinfection | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in the Number of Endothelial Microparticle at 6 months | 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 | Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Brachia-ankle Pulse Wave Velocity(baPWV) | 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) | Compare the changes of traditional inflammatory biomarkers:hs-CRP and IL-6 over a 6-month follow-up period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jun Ying Yang, Master | First Affiliated Hospital, Sun Yat-Sen University | Study Director |
| Jun Tao, M.D.,phD. | First Affiliated Hospital, Sun Yat-Sen University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong | 510080 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28452620 | Derived | Zhou QB, Xia WH, Ren J, Yu BB, Tong XZ, Chen YB, Chen S, Feng L, Dai J, Tao J, Yang JY. Effect of Intensive Periodontal Therapy on Blood Pressure and Endothelial Microparticles in Patients With Prehypertension and Periodontitis: A Randomized Controlled Trial. J Periodontol. 2017 Aug;88(8):711-722. doi: 10.1902/jop.2017.160447. Epub 2017 Apr 28. |
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| ID | Term |
|---|---|
| D055113 | Chronic Periodontitis |
| D058246 | Prehypertension |
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D002908 | Chronic Disease |
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|
| Periodontal care | Procedure |
|
|
| Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy |
| Expression of the Long non-protein-coding RNA(lncRNA) and microRNA | baseline |
| Changes in Malondialdehyde(MDA) and Superoxide Dismutase(SOD) | Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy |
| Change in Periodontal Inflamed Surface Area(PISA) | 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) | Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |