Actively Recruiting
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
Led by University of Catania · Updated on 2025-05-21
90
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of non-surgical periodontal treatment on early signs of endothelial dysfunction in people with peri-implantitis or peri-implant mucositis who do not have cardiovascular disease. This double-blind randomized-controlled clinical trial includes 90 participants divided into three groups: 30 with peri-implantitis, 30 with peri-implant mucositis, and 30 healthy controls without a history of periodontitis. The study aims to understand how periodontal health impacts cardiovascular function in these conditions. The treatment being studied is non-surgical periodontal therapy, specifically subgingival biofilm ultrasonic debridement. Participants are grouped based on their diagnosis, with one group receiving treatment for peri-implantitis, another for peri-implant mucositis, and a healthy control group without intervention. The study follows international guidelines for diagnosis and treatment and compares cardiovascular and periodontal parameters before and after the treatment. Participants will undergo assessments including clinical periodontal exams, blood tests, and non-invasive ultrasound measurements of cardiovascular health. Outcome measures include pulse wave velocity, carotid intima-media thickness, distensibility coefficient, and levels of advanced glycation end products, all evaluated at baseline and 8 weeks after treatment. The study monitors these parameters to assess the impact of periodontal therapy on early endothelial dysfunction over the study duration.
CONDITIONS
Brief Title
Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Peri-implantitis and Peri-implant Mucositis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinically diagnosed with peri-implantitis according to the EFP/AAP 2017 criteria (for peri-implantitis group)
- Clinically diagnosed with peri-implant mucositis according to the EFP/AAP 2017 criteria (for peri-implant mucositis group)
- Clinically diagnosed with healthy periodontum without periodontitis history according to the EFP/AAP 2017 criteria (for healthy group)
You will not qualify if you...
- Received periodontal treatment, implant surgery, antibiotics, NSAIDs, or immunosuppressants during the last 6 months
- Pregnancy
- Cardiovascular diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 8 weeks
Participants with peri-implantitis or peri-implant mucositis receive non-surgical periodontal treatment consisting of subgingival biofilm ultrasonic debridement. Healthy participants do not receive treatment.
1 baseline visit and 1 follow-up visit
Trial Site Locations
Total: 1 location
1
AOU Policlinico G. Rodolico
Catania, Italy, 95124
Actively Recruiting
Research Team
G
Gaetano Isola, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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