AtherosclerosisNCT05906810
Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Peri-implantitis and Peri-implant Mucositis
A study testing Non-surgical periodontal treatment in people with Atherosclerosis and Endothelial Dysfunction, run by University of Catania at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis, Endothelial Dysfunction, Peri-Implantitis
- What is being tested?
- Non-surgical periodontal treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- 5 Oct 2020to 20 Dec 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Clinically diagnosed with peri-implantitis according to the EFP/AAP 2017 criteria.
- Clinically diagnosed with peri-implant mucositis according to the EFP/AAP 2017 criteria.
- Clinically diagnosed with healthy periodontum withouth periodontitis history according to the EFP/AAP 2017 criteria.
Who cannot join
- Periodontal treatment, implant surgery, antibiotics, NSAIDs, immunosuppressants during the last 6 months.
- Pregnancy.
- Cardiovascular Diseases.
- PERI-IMPLANT MUCOSITIS GROUP
- Periodontal treatment, implant surgery, antibiotics, NSAIDs, immunosuppressants during the last 6 months.
- Pregnancy.
Show all 11Show fewer
- Cardiovascular Diseases.
- HEALTHY GROUP
- Scaling, antibiotics, NSAIDs, immunosuppressants during the last 6 months.
- Pregnancy.
- Cardiovascular Diseases.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
AOU Policlinico G. Rodolico
Catania, 95124
Gaetano Isola, DDS, +3909537800
About this study
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.
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.
Read the 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.
- Being tested
- Non-surgical periodontal treatment
- Medical subject headings
- Atherosclerosis, Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgical periodontal treatmentProcedure or surgery
Subgingival biofilm ultrasonic debridement
| Study group | Role | What they receive |
|---|---|---|
| Peri-implantitis | Experimental | Subjects diagnosed with peri-implantitis according to the most recent international guidelines and without cardiovascular diseases. Receives: Procedure: Non-surgical periodontal treatment |
| Peri-implant mucositis | Active comparator | Subjects diagnosed with peri-implant mucositis according to the most recent international guidelines and without cardiovascular diseases. Receives: Procedure: Non-surgical periodontal treatment |
| Healthy | No intervention | Subjects without periodontitis and with good gingival health. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse Wave Velocity carotid-femoral (PWV-CF)
The speed of pulse wave propagation between carotid-femoral sites
Measured: 8 weeks
Pulse Wave Velocity carotid-femoral (PWV-CR)
The speed of pulse wave propagation between carotid-radial sites
Measured: 8 weeks
Carotid Intima-Media Thickness (CIMT)
The thickness of the carotid intima and media
Measured: 8 weeks
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.
Measured: 8 weeks
Advanced Glycation End products (AGEs)
A group of endogenous heterogeneous compounds that are constantly formed under physiological conditions with prooxidant and cytotoxic properties. Measurements are performed by fluorescence spectroscopy technique.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start5 Oct 2020
- Primary completion20 Nov 2025 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The main objective of this study is to evaluate the efficacy of periodontal treatment on the improvement in cardiovascular parameters.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Catania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaetano Isola, University of Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05906810
- Sponsor's protocol ID
- 121-23
- Status last verified
- May 2025
- First submitted
- 7 Jun 2023
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No