Non-surgical treatment for gum disease's effect on blood vessel health
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.
This study is testing whether a non-surgical gum treatment can improve blood vessel health in people with gum disease and healthy individuals.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Sex | All |
| Sponsor | University of Catania Academic / other |
| Locations | 1 site (Catania) |
| Trial ID | NCT05906810 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effects of non-surgical periodontal treatment on endothelial dysfunction in patients with peri-implantitis and peri-implant mucositis, as well as healthy controls. It involves a double-blind randomized-controlled design with 90 participants divided into three groups: those with peri-implantitis, those with peri-implant mucositis, and healthy individuals. Clinical assessments, blood tests, and non-invasive ultrasound cardiovascular measurements are conducted before and after treatment to determine the impact of the intervention.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with peri-implantitis or peri-implant mucositis without a history of cardiovascular disease.
Not a fit: Patients with a history of cardiovascular diseases or those who have undergone recent periodontal treatments will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve vascular health in patients with gum disease, potentially reducing cardiovascular risks.
How similar studies have performed: While similar studies have explored the relationship between periodontal health and cardiovascular conditions, this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / 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.
Where this trial is running
Catania
- AOU Policlinico G. Rodolico — Catania, Italy (Recruiting)
Study contacts
- Study coordinator: Gaetano Isola, PhD
- Email: gaetano.isola@unict.it
- Phone: +39-095-378-2453
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.