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
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Atherosclerosis
• Endothelial Dysfunction
• Mucositis
• Peri-implant Mucositis
• Peri-Implantitis

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