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NCT Number: NCT05906797

Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Periodontitis.

A randomized-controlled clinical trial is conducted in order to evaluate the impact of non-surgical periodontal treatment on endothelial dysfunction parameters in subjects with periodontitis and without any cardiovascular disease.

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Mouth Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AOU Policlinico G. Rodolico

Catania, 95124, Italy

About this study

A randomized-controlled clinical trial is conducted in order to evaluate the impact of non-surgical periodontal treatment on endothelial dysfunction parameters in subjects with periodontitis.

44 patients with periodontitis treated with non surgical approach through Quadrant subgingival debridement or MINST.

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 periodontal subjects.

Who can participate

Healthy volunteers accepted: Yes

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

PERIODONTITIS GROUP

Inclusion criteria

  • Clinically diagnosed with periodontitis according to the EFP/AAP 2017 criteria.

Exclusion criteria

  • Periodontal treatment, antibiotics, NSAIDs, immunosuppressants during the last 6 months.
  • Pregnancy.
  • Cardiovascular Diseases.

Treatment and study plan

Non-surgical periodontal treatment by Q-SI

Procedure

Subgingival biofilm ultrasonic debridement

Non surgical periodontal debridement using MINST approach

Procedure

Non surgical periodontal treatment using MINST approach

Primary outcomes

  1. Flow-Mediated Dilation (FMD)

    Time frame: 6-months

    evaluation of Flow-Mediated Dilation changes in scale after treatment

Secondary outcomes

  1. Carotid Intima-Media Thickness (CIMT)

    Time frame: 6-months

    The thickness of the carotid intima and media changes in scale after treatment

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

    Time frame: 6-months

    The speed of pulse wave propagation between carotid-radial sites changes in scale after treatment

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

    Time frame: 6-months

    The speed of pulse wave propagation between carotid-femoral sites changes in scale after treatment

  4. Advanced Glycation End products (AGEs)

    Time frame: 6-months

    AGES changes in scale after treatment. 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.

  5. Periodontal changes

    Time frame: 6 months

    Changes in probing depth, clinical attachment loss, bleeding sites

  6. Advanced Glycation End products (AGEs)

    Time frame: 6-months

    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.

Other outcomes

  1. Distensibility Coefficient (DC)

    Time frame: 6-months

    The relative change in luminal area during systole for a given pressure change (pulsed pressure), will be calculated assuming the lumen to be circular.

Interested in participating?

Completed

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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 Periodontitis: a Randomized-controlled Clinical Trial.

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jun 18, 2023
Registry last updated
Sep 15, 2026

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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