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NCT Number: NCT05906810

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

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.

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Endothelial Dysfunction Mouth Diseases Peri-Implantitis Peri-implant Mucositis Periodontal Diseases Stomatognathic Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AOU Policlinico G. Rodolico

Catania, 95124, Italy

Location status: Recruiting

Location contact

Gaetano Isola, DDS

CONTACT

+3909537800

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non-surgical periodontal treatment

Procedure

Subgingival biofilm ultrasonic debridement

Primary outcomes

  1. Pulse Wave Velocity carotid-femoral (PWV-CF)

    Time frame: 8 weeks

    The speed of pulse wave propagation between carotid-femoral sites

  2. Pulse Wave Velocity carotid-femoral (PWV-CR)

    Time frame: 8 weeks

    The speed of pulse wave propagation between carotid-radial sites

  3. Carotid Intima-Media Thickness (CIMT)

    Time frame: 8 weeks

    The thickness of the carotid intima and media

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gaetano Isola, PhD

CONTACT

[email protected]

+39-095-378-2453 ext. CT

Sponsors and collaborators

Lead sponsor

University of Catania

Other

Registry information

Official study 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.

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jun 18, 2023
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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