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

Not Applicable

Recruiting

• Conditions: Endothelial Dysfunction; Peri-implant Mucositis; Peri-Implantitis; Atherosclerosis
• Interventions: Procedure: Non-surgical periodontal treatment

• Registration Number: NCT05906810
• Lead Sponsor: University of Catania

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.

Study Timeline

• Study Start: 2020-10-05
• Study First Submitted: 2023-06-07
• Study First Submitted QC: 2023-06-07
• Study First Posted: 2023-06-18
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-18
• Last Update Posted: 2025-05-21
• Primary Completion: 2025-11-20
• Study Completion: 2025-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peri-implantitis	Non-surgical periodontal treatment	Subjects diagnosed with peri-implantitis according to the most recent international guidelines and without cardiovascular diseases.
Peri-implant mucositis	Non-surgical periodontal treatment	Subjects diagnosed with peri-implant mucositis according to the most recent international guidelines and without cardiovascular diseases.

Primary Outcome Measures

Name	Time	Method
Pulse Wave Velocity carotid-femoral (PWV-CF)	8 weeks	The speed of pulse wave propagation between carotid-femoral sites
Pulse Wave Velocity carotid-femoral (PWV-CR)	8 weeks	The speed of pulse wave propagation between carotid-radial sites
Carotid Intima-Media Thickness (CIMT)	8 weeks	The thickness of the carotid intima and media
Distensibility Coefficient (DC)	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)	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.

Trial Locations

Locations (1)

AOU Policlinico G. Rodolico; 🇮🇹 Catania, Italy