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The investigators wish to assess whether intensive periodontal therapy will reduce the burden of chronic periodontal disease and will cause regression or prevent progression of atherosclerosis assessed by a surrogate end-point (carotid intima-media thickness) at 24 months compared to control periodontal therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive Periodontal Treatment (IPT) | Active Comparator |
| |
| Control Periodontal Treatment (CPT) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive Periodontal Treatment | Procedure |
| ||
| Control Periodontal Treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Common Carotid Intima-media Thickness (cIMT) | Assess whether intensive periodontal therapy will cause regression or prevent progression of atherosclerosis assessed by carotid intima-media thickness at 24 months compared to standard periodontal therapy. | cIMT will be assessed at Baseline, 12 and 24 months after periodontal treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Brachial artery Flow-mediated dilatation (FMD) | Assess whether pre-treatment (24hrs before) with remote ischaemic pre-conditioning will prevent acute inflammatory endothelial dysfunction induced by intensive periodontal treatment | FMD will be assessed at baseline, 24 hours and 1 week after periodontal treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Deanfield, MD | UCL | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCL-Eastman Dental Institute | London | WC1X 8LD | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34107730 | Derived | Orlandi M, Masi S, Bhowruth D, Leira Y, Georgiopoulos G, Yellon D, Hingorani A, Chiesa ST, Hausenloy DJ, Deanfield J, D'Aiuto F. Remote Ischemic Preconditioning Protects Against Endothelial Dysfunction in a Human Model of Systemic Inflammation: A Randomized Clinical Trial. Arterioscler Thromb Vasc Biol. 2021 Aug;41(8):e417-e426. doi: 10.1161/ATVBAHA.121.316388. Epub 2021 Jun 10. |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| C563733 | Carotid Intimal Medial Thickness 1 |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| Procedure |
|
| Pulse-wave velocity (PWV) |
Assess whether intensive periodontal therapy will cause amelioration of PWV at 12, 18 and 24 months follow up compared to standard periodontal therapy. |
| PWV will be assessed at baseline, 2, 6, 12, 18 and 24 months following periodontal treatment |
| Brachial artery Flow-mediated dilatation (FMD) | Assess whether intensive periodontal therapy will cause amelioration of FMD at 12, 18 and 24 months follow up compared to standard periodontal therapy. | FMD will be assessed at baseline, 2 , 6 , 12 , 18 and 24 months following periodontal treatment |
| Blood inflammatory markers | Assess whether intensive periodontal therapy will cause changes in the blood inflammatory markers profile at 2, 6, 12, 18 and 24 months follow up compared to standard periodontal therapy. | Inflammatory mediators profile will be assessed at baseline, 2, 6, 12, 18 and 24 months following periodontal treatment |
| Oxidative stress | Assess whether intensive periodontal therapy will cause changes in the oxidative stress profile at 2, 6, 12, 18 and 24 months follow up compared to standard periodontal therapy. | Oxidative stress profile will be assessed at baseline, 2, 6, 12, 18 and 24 months following periodontal treatment |