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A double-blind randomized-controlled clinical trial is conducted in order to evaluate the impact of non-surgical periodontal treatment on endothelial dysfunction parameters in subjects with peri-implantitis/peri-implant mucositis and without any cardiovascular disease.
A double-blind randomized-controlled clinical trial is conducted in order to evaluate the impact of non-surgical periodontal treatment on endothelial dysfunction parameters in subjects with peri-implantitis/peri-implant mucositis and without any cardiovascular disease.
90 patients: 30 with peri-implantitis, 30 with peri-implant mucositis and 30 healthy controls and without periodontitis history.
All the patients are assessed for clinical, periodontal, blood and non-invasive ultrasound cardiovascular parameters. Measurements are taken before and after initial periodontal treatment in the peri-implantitis/peri-implant mucositis subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peri-implantitis | Experimental | Subjects diagnosed with peri-implantitis according to the most recent international guidelines and without cardiovascular diseases. |
|
| Peri-implant mucositis | Active Comparator | Subjects diagnosed with peri-implant mucositis according to the most recent international guidelines and without cardiovascular diseases. |
|
| Healthy | No Intervention | Subjects without periodontitis and with good gingival health. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-surgical periodontal treatment | Procedure | Subgingival biofilm ultrasonic debridement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pulse Wave Velocity carotid-femoral (PWV-CF) | The speed of pulse wave propagation between carotid-femoral sites | 8 weeks |
| Pulse Wave Velocity carotid-femoral (PWV-CR) | The speed of pulse wave propagation between carotid-radial sites | 8 weeks |
| Carotid Intima-Media Thickness (CIMT) | The thickness of the carotid intima and media | 8 weeks |
| Distensibility Coefficient (DC) | The relative change in luminal area during systole for a given pressure change (pulsed pressure), will be calculated assuming the lumen to be circular. | 8 weeks |
| Advanced Glycation End products (AGEs) | A group of endogenous heterogeneous compounds that are constantly formed under physiological conditions with prooxidant and cytotoxic properties. Measurements are performed by fluorescence spectroscopy technique. | 8 weeks |
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PERI-IMPLANTITIS GROUP
Inclusion Criteria:
• Clinically diagnosed with peri-implantitis according to the EFP/AAP 2017 criteria.
Exclusion Criteria:
PERI-IMPLANT MUCOSITIS GROUP
Inclusion Criteria:
• Clinically diagnosed with peri-implant mucositis according to the EFP/AAP 2017 criteria.
Exclusion Criteria:
HEALTHY GROUP
Inclusion Criteria:
• Clinically diagnosed with healthy periodontum withouth periodontitis history according to the EFP/AAP 2017 criteria.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gaetano Isola, PhD | Contact | +39-095-378-2453 | CT | gaetano.isola@unict.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOU Policlinico G. Rodolico | Recruiting | Catania | 95124 | Italy |
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The main objective of this study is to evaluate the efficacy of periodontal treatment on the improvement in cardiovascular parameters.
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Sealed envelopes
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D057873 | Peri-Implantitis |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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