Clinical trial NCT05906810: Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Peri-implantitis and Peri-implant Mucositis
Official title: Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Peri-implantitis and Peri-implant Mucositis: a Randomized-controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atherosclerosis
Endothelial Dysfunction
Peri-Implantitis
Peri-implant Mucositis
Lead sponsor: University of Catania
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The main objective of this study is to evaluate the efficacy of periodontal treatment on the improvement in cardiovascular parameters.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility 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.

Primary outcomes:
measure: Pulse Wave Velocity carotid-femoral (PWV-CF)
timeFrame: 8 weeks
measure: Pulse Wave Velocity carotid-femoral (PWV-CR)
timeFrame: 8 weeks
measure: Carotid Intima-Media Thickness (CIMT)
timeFrame: 8 weeks
measure: Distensibility Coefficient (DC)
timeFrame: 8 weeks
measure: Advanced Glycation End products (AGEs)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Catania
country: Italy
facility: AOU Policlinico G. Rodolico
Study officials:
References: