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

ConditionsAtherosclerosisEndothelial DysfunctionPeri-ImplantitisPeri-implant Mucositis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of Catania

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

Periodontal treatment, implant surgery, antibiotics, NSAIDs, immunosuppressants during the last 6 months.

Pregnancy.

Cardiovascular Diseases.

Periodontal treatment, implant surgery, antibiotics, NSAIDs, immunosuppressants during the last 6 months.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Non-surgical periodontal treatment

    Procedure/Surgery

    Subgingival biofilm ultrasonic debridement

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Peri-implantitisExperimental treatment 1 intervention
Group B: Peri-implant mucositisActive comparator 1 intervention
Group C: HealthyNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Pulse Wave Velocity carotid-femoral (PWV-CF)

The speed of pulse wave propagation between carotid-femoral sites

Time frame
8 weeks
2

Pulse Wave Velocity carotid-femoral (PWV-CR)

The speed of pulse wave propagation between carotid-radial sites

Time frame
8 weeks
3

Carotid Intima-Media Thickness (CIMT)

The thickness of the carotid intima and media

Time frame
8 weeks
4

Distensibility Coefficient (DC)

The relative change in luminal area during systole for a given pressure change (pulsed pressure), will be calculated assuming the lumen to be circular.

Time frame
8 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Catania

Lead sponsor

Source ClinicalTrials.gov
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