Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Peri-implantitis and Peri-implant Mucositis

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Peri-implantitis and Peri-implant Mucositis: a Randomized-controlled Clinical Trial.

Conditions
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Atherosclerosis, Endothelial Dysfunction, Peri-Implantitis, Peri-implant Mucositis

Intervention / Treatment
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* Procedure: Non-surgical periodontal treatment


Participation Criteria
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Eligibility Criteria
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PERI-IMPLANTITIS GROUP Inclusion Criteria: • Clinically diagnosed with peri-implantitis according to the EFP/AAP 2017 criteria. Exclusion Criteria: Periodontal treatment, implant surgery, antibiotics, NSAIDs, immunosuppressants during the last 6 months. Pregnancy. Cardiovascular Diseases. PERI-IMPLANT MUCOSITIS GROUP Inclusion Criteria: • Clinically diagnosed with peri-implant mucositis according to the EFP/AAP 2017 criteria. Exclusion Criteria: Periodontal treatment, implant surgery, antibiotics, NSAIDs, immunosuppressants during the last 6 months. Pregnancy. Cardiovascular Diseases. HEALTHY GROUP Inclusion Criteria: • Clinically diagnosed with healthy periodontum withouth periodontitis history according to the EFP/AAP 2017 criteria. Exclusion Criteria: Scaling, antibiotics, NSAIDs, immunosuppressants during the last 6 months. Pregnancy. Cardiovascular Diseases.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The main objective of this study is to evaluate the efficacy of periodontal treatment on the improvement in cardiovascular parameters.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peri-implantitis<br>Subjects diagnosed with peri-implantitis according to the most recent international guidelines and without cardiovascular diseases. | Procedure: Non-surgical periodontal treatment<br>* Subgingival biofilm ultrasonic debridement<br>|
| Active Comparator: Peri-implant mucositis<br>Subjects diagnosed with peri-implant mucositis according to the most recent international guidelines and without cardiovascular diseases. | Procedure: Non-surgical periodontal treatment<br>* Subgingival biofilm ultrasonic debridement<br>|
| No Intervention: Healthy<br>Subjects without periodontitis and with good gingival health. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |