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

February 2, 2024 updated by: Gaetano Isola, University of Catania

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Catania, Italy, 95124
        • Recruiting
        • AOU Policlinico G. Rodolico
        • Contact:
          • Gaetano Isola, DDS
          • Phone Number: +3909537800

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Healthy
Subjects without periodontitis and with good gingival health.
Experimental: Peri-implantitis
Subjects diagnosed with peri-implantitis according to the most recent international guidelines and without cardiovascular diseases.
Procedure: Non-surgical periodontal treatment
Subgingival biofilm ultrasonic debridement
Active Comparator: Peri-implant mucositis
Subjects diagnosed with peri-implant mucositis according to the most recent international guidelines and without cardiovascular diseases.
Procedure: Non-surgical periodontal treatment
Subgingival biofilm ultrasonic debridement

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Catania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2020

Primary Completion (Estimated)

November 20, 2025

Study Completion (Estimated)

December 20, 2025

Study Registration Dates

First Submitted

June 7, 2023

First Submitted That Met QC Criteria

June 7, 2023

First Posted (Actual)

June 18, 2023

Study Record Updates

Last Update Posted (Actual)

February 5, 2024

Last Update Submitted That Met QC Criteria

February 2, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 121-23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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