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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atherosclerosis
- Sponsor
- University of Catania
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Pulse Wave Velocity carotid-femoral (PWV-CF)
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
Brief Summary
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
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.
Investigators
Gaetano Isola
Researcher
University of Catania
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Pulse Wave Velocity carotid-femoral (PWV-CF)
Time Frame: 8 weeks
The speed of pulse wave propagation between carotid-femoral sites
Pulse Wave Velocity carotid-femoral (PWV-CR)
Time Frame: 8 weeks
The speed of pulse wave propagation between carotid-radial sites
Carotid Intima-Media Thickness (CIMT)
Time Frame: 8 weeks
The thickness of the carotid intima and media
Distensibility Coefficient (DC)
Time Frame: 8 weeks
The relative change in luminal area during systole for a given pressure change (pulsed pressure), will be calculated assuming the lumen to be circular.
Advanced Glycation End products (AGEs)
Time Frame: 8 weeks
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.