AtherosclerosisNCT05906797
Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Periodontitis.
A study testing Non-surgical periodontal treatment by Q-SI and Non surgical periodontal debridement using MINST approach in people with Atherosclerosis and Periodontitis, run by University of Catania at 1 site in Italy.
Trial summary
A randomized-controlled clinical trial is conducted in order to evaluate the impact of non-surgical periodontal treatment on endothelial dysfunction parameters in subjects with periodontitis 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, Periodontitis
- What is being tested?
- Non-surgical periodontal treatment by Q-SI and Non surgical periodontal debridement using MINST approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteItaly
- Study dates
- 7 Sep 2020to 12 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 periodontitis according to the EFP/AAP 2017 criteria.
Who cannot join
- Periodontal treatment, antibiotics, NSAIDs, immunosuppressants during the last 6 months.
- Pregnancy.
- Cardiovascular Diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Periodontitis: a Randomized-controlled Clinical Trial.
A randomized-controlled clinical trial is conducted in order to evaluate the impact of non-surgical periodontal treatment on endothelial dysfunction parameters in subjects with periodontitis and without any cardiovascular disease.
Read the detailed description
A randomized-controlled clinical trial is conducted in order to evaluate the impact of non-surgical periodontal treatment on endothelial dysfunction parameters in subjects with periodontitis.
44 patients with periodontitis treated with non surgical approach through Quadrant subgingival debridement or MINST.
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 periodontal subjects.
- Conditions
- Atherosclerosis, Periodontitis
- Being tested
- Non-surgical periodontal treatment by Q-SI, Non surgical periodontal debridement using MINST approach
- Medical subject headings
- Atherosclerosis, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgical periodontal treatment by Q-SIProcedure or surgery
Subgingival biofilm ultrasonic debridement
Non surgical periodontal debridement using MINST approachProcedure or surgery
Non surgical periodontal treatment using MINST approach
| Study group | Role | What they receive |
|---|---|---|
| Periodontitis - MINST | Experimental | Subjects diagnosed with periodontitis according to the most recent international guidelines and without cardiovascular diseases treated with MINST approach. Receives: Procedure: Non surgical periodontal debridement using MINST approach |
| Periodontitis - Q-SI | Active comparator | Subjects with periodontitis and without CVD treated by Q-SI approach Receives: Procedure: Non-surgical periodontal treatment by Q-SI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow-Mediated Dilation (FMD)
evaluation of Flow-Mediated Dilation changes in scale after treatment
Measured: 6-months
Secondary outcomes (6)
Carotid Intima-Media Thickness (CIMT)
The thickness of the carotid intima and media changes in scale after treatment
Measured: 6-months
Pulse Wave Velocity carotid-femoral (PWV-CR)
The speed of pulse wave propagation between carotid-radial sites changes in scale after treatment
Measured: 6-months
Pulse Wave Velocity carotid-femoral (PWV-CF)
The speed of pulse wave propagation between carotid-femoral sites changes in scale after treatment
Measured: 6-months
Advanced Glycation End products (AGEs)
AGES changes in scale after treatment. 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: 6-months
Periodontal changes
Changes in probing depth, clinical attachment loss, bleeding sites
Measured: 6 months
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: 6-months
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 start7 Sep 2020
- Primary completion30 Oct 2023
- Study completion12 Dec 2023
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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
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
- NCT05906797
- Sponsor's protocol ID
- 121-22
- Status last verified
- Sep 2026
- First submitted
- 7 Jun 2023
- Last updated
- 15 Sep 2026
- Results posted
- 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 15 Sep 2026. 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 Periodontitis: a Randomized-controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT05906797
- Acronym / sponsor ID
- 121-22
- Conditions
- Atherosclerosis, Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of CataniaUniversity, hospital or other
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 12 Dec 2023 (actual)
- 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 randomized-controlled clinical trial is conducted in order to evaluate the impact of non-surgical periodontal treatment on endothelial dysfunction parameters in subjects with periodontitis and without any cardiovascular disease.
Detailed description
A randomized-controlled clinical trial is conducted in order to evaluate the impact of non-surgical periodontal treatment on endothelial dysfunction parameters in subjects with periodontitis.
44 patients with periodontitis treated with non surgical approach through Quadrant subgingival debridement or MINST.
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 periodontal subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periodontitis - MINST | Experimental | Procedure: Non surgical periodontal debridement using MINST approachSubjects diagnosed with periodontitis according to the most recent international guidelines and without cardiovascular diseases treated with MINST approach. |
| Periodontitis - Q-SI | Active comparator | Procedure: Non-surgical periodontal treatment by Q-SISubjects with periodontitis and without CVD treated by Q-SI approach |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Clinically diagnosed with periodontitis according to the EFP/AAP 2017 criteria.
Key exclusion criteria (3 listed)
- Periodontal treatment, antibiotics, NSAIDs, immunosuppressants during the last 6 months.
- Pregnancy.
- Cardiovascular Diseases.
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 treatment by Q-SISubgingival biofilm ultrasonic debridement | Procedure or surgery | Periodontitis - Q-SI |
| Non surgical periodontal debridement using MINST approachNon surgical periodontal treatment using MINST approach | Procedure or surgery | Periodontitis - MINST |
Primary outcome
Flow-Mediated Dilation (FMD)
Time frame: 6-months
evaluation of Flow-Mediated Dilation changes in scale after treatment
6 secondary outcomes
Carotid Intima-Media Thickness (CIMT)
Time frame: 6-months
Pulse Wave Velocity carotid-femoral (PWV-CR)
Time frame: 6-months
Pulse Wave Velocity carotid-femoral (PWV-CF)
Time frame: 6-months
Advanced Glycation End products (AGEs)
Time frame: 6-months
Periodontal changes
Time frame: 6 months
Advanced Glycation End products (AGEs)
Time frame: 6-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 by Q-SI and Non surgical periodontal debridement using MINST approach in people with Atherosclerosis and Periodontitis, 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 15 Sep 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flow-Mediated Dilation (FMD) (time frame: 6-months). 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 15 Sep 2026.