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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

Primary Purpose

Atherosclerosis, Endothelial Dysfunction, Peri-Implantitis

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Non-surgical periodontal treatment
Sponsored by
University of Catania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atherosclerosis

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.

Sites / Locations

  • AOU Policlinico G. RodolicoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Peri-implantitis

Peri-implant mucositis

Healthy

Arm Description

Subjects diagnosed with peri-implantitis according to the most recent international guidelines and without cardiovascular diseases.

Subjects diagnosed with peri-implant mucositis according to the most recent international guidelines and without cardiovascular diseases.

Subjects without periodontitis and with good gingival health.

Outcomes

Primary Outcome Measures

Pulse Wave Velocity carotid-femoral (PWV-CF)
The speed of pulse wave propagation between carotid-femoral sites
Pulse Wave Velocity carotid-femoral (PWV-CR)
The speed of pulse wave propagation between carotid-radial sites
Carotid Intima-Media Thickness (CIMT)
The thickness of the carotid intima and media
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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 7, 2023
Last Updated
June 7, 2023
Sponsor
University of Catania
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1. Study Identification

Unique Protocol Identification Number
NCT05906810
Brief Title
Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Peri-implantitis and Peri-implant Mucositis
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 5, 2020 (Actual)
Primary Completion Date
November 20, 2023 (Anticipated)
Study Completion Date
December 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Catania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis, Endothelial Dysfunction, Peri-Implantitis, Peri-implant Mucositis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The main objective of this study is to evaluate the efficacy of periodontal treatment on the improvement in cardiovascular parameters.
Masking
ParticipantCare ProviderInvestigator
Masking Description
Sealed envelopes
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Peri-implantitis
Arm Type
Experimental
Arm Description
Subjects diagnosed with peri-implantitis according to the most recent international guidelines and without cardiovascular diseases.
Arm Title
Peri-implant mucositis
Arm Type
Active Comparator
Arm Description
Subjects diagnosed with peri-implant mucositis according to the most recent international guidelines and without cardiovascular diseases.
Arm Title
Healthy
Arm Type
No Intervention
Arm Description
Subjects without periodontitis and with good gingival health.
Intervention Type
Procedure
Intervention Name(s)
Non-surgical periodontal treatment
Intervention Description
Subgingival biofilm ultrasonic debridement
Primary Outcome Measure Information:
Title
Pulse Wave Velocity carotid-femoral (PWV-CF)
Description
The speed of pulse wave propagation between carotid-femoral sites
Time Frame
8 weeks
Title
Pulse Wave Velocity carotid-femoral (PWV-CR)
Description
The speed of pulse wave propagation between carotid-radial sites
Time Frame
8 weeks
Title
Carotid Intima-Media Thickness (CIMT)
Description
The thickness of the carotid intima and media
Time Frame
8 weeks
Title
Distensibility Coefficient (DC)
Description
The relative change in luminal area during systole for a given pressure change (pulsed pressure), will be calculated assuming the lumen to be circular.
Time Frame
8 weeks
Title
Advanced Glycation End products (AGEs)
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gaetano Isola, PhD
Phone
+39-095-378-2453
Ext
CT
Email
gaetano.isola@unict.it
Facility Information:
Facility Name
AOU Policlinico G. Rodolico
City
Catania
ZIP/Postal Code
95124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaetano Isola, DDS
Phone
+3909537800

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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