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NCT05906810 Clinical Trial

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

Atherosclerosis Clinical Trial

Official title:
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.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05906810
Other study ID # 121-23
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 5, 2020
Est. completion date December 20, 2025

Study information
Verified date February 2024
Source University of Catania
Contact Gaetano Isola, PhD
Phone +39-095-378-2453
Email gaetano.isola@unict.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 90
Est. completion date December 20, 2025
Est. primary completion date November 20, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Non-surgical periodontal treatment
Subgingival biofilm ultrasonic debridement

Locations
Country Name City State
Italy AOU Policlinico G. Rodolico Catania

Sponsors (1)
Lead Sponsor Collaborator
University of Catania

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pulse Wave Velocity carotid-femoral (PWV-CF) The speed of pulse wave propagation between carotid-femoral sites 8 weeks
Primary Pulse Wave Velocity carotid-femoral (PWV-CR) The speed of pulse wave propagation between carotid-radial sites 8 weeks
Primary Carotid Intima-Media Thickness (CIMT) The thickness of the carotid intima and media 8 weeks
Primary 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
Primary 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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