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

NCT ID: NCT05906797

Last Updated: 2023-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-07

Study Completion Date

2023-12-12

Brief Summary

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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 periodontitis and without any cardiovascular disease.

Detailed Description

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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 periodontitis and without any cardiovascular disease.

60 patients: 30 with periodontitis and 30 with 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 periodontal subjects.

Conditions

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Atherosclerosis Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Periodontitis

Subjects diagnosed with periodontitis according to the most recent international guidelines and without cardiovascular diseases.

Group Type EXPERIMENTAL

Non-surgical periodontal treatment

Intervention Type PROCEDURE

Subgingival biofilm ultrasonic debridement

Healthy

Subjects without periodontitis and with good gingival health.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Non-surgical periodontal treatment

Subgingival biofilm ultrasonic debridement

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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


* Clinically diagnosed with healthy periodontum withouth periodontitis history according to the EFP/AAP 2017 criteria.

Exclusion Criteria

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

HEALTHY GROUP


* Scaling, antibiotics, NSAIDs, immunosuppressants during the last 6 months.
* Pregnancy.
* Cardiovascular Diseases.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Catania

OTHER

Sponsor Role lead

Responsible Party

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Gaetano Isola

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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AOU Policlinico G. Rodolico

Catania, , Italy

Site Status

Countries

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Italy

Other Identifiers

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121-22

Identifier Type: -

Identifier Source: org_study_id