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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05906810
- Acronym / sponsor ID
- 121-23
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of CataniaUniversity, hospital or other
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 20 Nov 2025 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- The main objective of this study is to evaluate the efficacy of periodontal treatment on the improvement in cardiovascular parameters.
| Arm | Type | Receives |
|---|---|---|
| Peri-implantitis | Experimental | Procedure: Non-surgical periodontal treatmentSubjects diagnosed with peri-implantitis according to the most recent international guidelines and without cardiovascular diseases. |
| Peri-implant mucositis | Active comparator | Procedure: Non-surgical periodontal treatmentSubjects diagnosed with peri-implant mucositis according to the most recent international guidelines and without cardiovascular diseases. |
| Healthy | No intervention | –Subjects without periodontitis and with good gingival health. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-surgical periodontal treatmentSubgingival biofilm ultrasonic debridement | Procedure or surgery | Peri-implant mucositis, Peri-implantitis |
Primary outcome
Pulse Wave Velocity carotid-femoral (PWV-CF)
Time frame: 8 weeks
The speed of pulse wave propagation between carotid-femoral sites
Pulse Wave Velocity carotid-femoral (PWV-CR)
Time frame: 8 weeks
The speed of pulse wave propagation between carotid-radial sites
Carotid Intima-Media Thickness (CIMT)
Time frame: 8 weeks
The thickness of the carotid intima and media
Distensibility Coefficient (DC)
Time frame: 8 weeks
The relative change in luminal area during systole for a given pressure change (pulsed pressure), will be calculated assuming the lumen to be circular.
Advanced Glycation End products (AGEs)
Time frame: 8 weeks
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-surgical periodontal treatment in people with Atherosclerosis and Endothelial Dysfunction, run by University of Catania at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gaetano Isola, PhD (+39-095-378-2453 ext. CT, gaetano.isola@unict.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse Wave Velocity carotid-femoral (PWV-CF) (time frame: 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.