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

NCT ID: NCT05906810

Last Updated: 2025-05-21

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

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-05

Study Completion Date

2025-12-20

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 peri-implantitis/peri-implant mucositis 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 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.

Conditions

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Atherosclerosis Endothelial Dysfunction Peri-Implantitis Peri-implant Mucositis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The main objective of this study is to evaluate the efficacy of periodontal treatment on the improvement in cardiovascular parameters.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
Sealed envelopes

Study Groups

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Peri-implantitis

Subjects diagnosed with peri-implantitis 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

Peri-implant mucositis

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

Group Type ACTIVE_COMPARATOR

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 peri-implantitis according to the EFP/AAP 2017 criteria.


• Clinically diagnosed with peri-implant mucositis 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, implant surgery, antibiotics, NSAIDs, immunosuppressants during the last 6 months.
* Pregnancy.
* Cardiovascular Diseases.

PERI-IMPLANT MUCOSITIS GROUP


* Periodontal treatment, implant surgery, 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 RECRUITING

Countries

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Italy

Central Contacts

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Gaetano Isola, PhD

Role: CONTACT

+39-095-378-2453 ext. CT

Facility Contacts

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Gaetano Isola, DDS

Role: primary

+3909537800

Other Identifiers

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121-23

Identifier Type: -

Identifier Source: org_study_id

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