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

Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Periodontitis: a Randomized-controlled Clinical Trial.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05906797
Enrollment
44
Registered
2023-06-18
Start date
2020-09-07
Completion date
2023-12-12
Last updated
2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis, Periodontitis

Brief summary

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.

Detailed description

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.

Interventions

PROCEDURENon-surgical periodontal treatment by Q-SI

Subgingival biofilm ultrasonic debridement

PROCEDURENon surgical periodontal debridement using MINST approach

Non surgical periodontal treatment using MINST approach

Sponsors

University of Catania
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Flow-Mediated Dilation (FMD)6-monthsevaluation of Flow-Mediated Dilation changes in scale after treatment

Secondary

MeasureTime frameDescription
Carotid Intima-Media Thickness (CIMT)6-monthsThe thickness of the carotid intima and media changes in scale after treatment
Pulse Wave Velocity carotid-femoral (PWV-CR)6-monthsThe speed of pulse wave propagation between carotid-radial sites changes in scale after treatment
Pulse Wave Velocity carotid-femoral (PWV-CF)6-monthsThe speed of pulse wave propagation between carotid-femoral sites changes in scale after treatment
Advanced Glycation End products (AGEs)6-monthsAGES 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.
Periodontal changes6 monthsChanges in probing depth, clinical attachment loss, bleeding sites

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026