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

University of Catania

Status: Enrolling

Conditions: Endothelial Dysfunction; Peri-implant Mucositis; Atherosclerosis; Peri-Implantitis

Treatments: Procedure: Non-surgical periodontal treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT05906810

121-23

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 90 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups

Peri-implantitis

Experimental group

Description:

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

Treatment:

Procedure: Non-surgical periodontal treatment

Peri-implant mucositis

Active Comparator group

Description:

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

Treatment:

Procedure: Non-surgical periodontal treatment

Healthy

No Intervention group

Description:

Subjects without periodontitis and with good gingival health.