NCT05906810

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 5, 2020

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

June 7, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2025

Completed
Last Updated

May 21, 2025

Status Verified

May 1, 2025

Enrollment Period

5.1 years

First QC Date

June 7, 2023

Last Update Submit

May 18, 2025

Conditions

AtherosclerosisEndothelial DysfunctionPeri-ImplantitisPeri-implant Mucositis

Outcome Measures

Primary Outcomes (5)

  • Pulse Wave Velocity carotid-femoral (PWV-CF)

    The speed of pulse wave propagation between carotid-femoral sites

    8 weeks

  • Pulse Wave Velocity carotid-femoral (PWV-CR)

    The speed of pulse wave propagation between carotid-radial sites

    8 weeks

  • Carotid Intima-Media Thickness (CIMT)

    The thickness of the carotid intima and media

    8 weeks

  • 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

  • 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

Study Arms (3)

Peri-implantitis

EXPERIMENTAL

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

Procedure: Non-surgical periodontal treatment

Peri-implant mucositis

ACTIVE COMPARATOR

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

Procedure: Non-surgical periodontal treatment

Healthy

NO INTERVENTION

Subjects without periodontitis and with good gingival health.

Interventions

Non-surgical periodontal treatmentPROCEDURE

Subgingival biofilm ultrasonic debridement

Peri-implant mucositisPeri-implantitis

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinically diagnosed with peri-implantitis according to the EFP/AAP 2017 criteria.

You may not qualify if:

  • Periodontal treatment, implant surgery, antibiotics, NSAIDs, immunosuppressants during the last 6 months.
  • Pregnancy.
  • Cardiovascular Diseases.
  • PERI-IMPLANT MUCOSITIS GROUP
  • Clinically diagnosed with peri-implant mucositis according to the EFP/AAP 2017 criteria.
  • Periodontal treatment, implant surgery, antibiotics, NSAIDs, immunosuppressants during the last 6 months.
  • Pregnancy.
  • Cardiovascular Diseases.
  • HEALTHY GROUP
  • Clinically diagnosed with healthy periodontum withouth periodontitis history according to the EFP/AAP 2017 criteria.
  • Scaling, antibiotics, NSAIDs, immunosuppressants during the last 6 months.
  • Pregnancy.
  • Cardiovascular Diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AOU Policlinico G. Rodolico

Catania, 95124, Italy

RECRUITING

MeSH Terms

Conditions

AtherosclerosisPeri-Implantitis

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Central Study Contacts

Gaetano Isola, PhD

CONTACT

+39-095-378-2453gaetano.isola@unict.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Sealed envelopes
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The main objective of this study is to evaluate the efficacy of periodontal treatment on the improvement in cardiovascular parameters.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

June 7, 2023

First Posted

June 18, 2023

Study Start

October 5, 2020

Primary Completion

November 20, 2025

Study Completion

December 20, 2025

Last Updated

May 21, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)