Metabolic DisturbanceNCT04335344
Role of suPAR in Periodontitis and CVD
An observational study of Metabolic Disturbance and Periodontal Diseases, run by University of Messina at 1 site in Italy.
Trial summary
soluble urokinase-type plasminogen activator receptor (suPAR) plays a key role in endothelial function and may be a link for the known interaction of periodontitis and cardiovascular disease (CVD). Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Disturbance, Periodontal Diseases
- What is being tested?
- Observation of suPAR plasma and salivary levels
- How many people
- 326 participants
- Where
- 1 siteItaly
- Study dates
- 15 Feb 2015to 25 Feb 2020
- Phase
- Observational
- 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy subjects (n=33) and patients with periodontitis (n=35), CVD (n=34), and a combination of periodontitis + CVD (n=34) were enrolled in the present study.
Who may be able to join
- Presence of at least 15 teeth
- CP with a minimum of 40% of sites with a clinical attachment level (CAL) ≥2mm and probing depth (PD) ≥4mm;
- Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs
- Presence of ≥40% sites with bleeding on probing (BOP)
Who cannot join
- Intake of contraceptives
- Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study
- Status of pregnancy or lactation
- Previous history of excessive drinking
- Allergy to local anaesthetic
- Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Plasma and Salivary suPAR in Periodontitis and CVD Patients
soluble urokinase-type plasminogen activator receptor (suPAR) plays a key role in endothelial function and may be a link for the known interaction of periodontitis and cardiovascular disease (CVD). The investigators compared the impact of gingival health, periodontitis (CP), CHD or of both diseases (CP+CHD) on saliva and serum suPAR levels.
Read the detailed description
The aim of this study was to evaluate a possible association between both saliva and serum suPAR levels in patients with CP and with CVD and if the serum suPAR levels are mediated by serum CRP.
- Conditions
- Metabolic Disturbance, Periodontal Diseases
- Being tested
- Observation of suPAR plasma and salivary levels
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation of suPAR plasma and salivary levelsOther
Evaluation of suPAR plasma level and correlation of plasma suPAR levels with periodontal and cardiovascular disease
| Study group | Role | What they receive |
|---|---|---|
| Control | Healthy patients Receives: Other: Observation of suPAR plasma and salivary levels | |
| Periodontitis | Patients with periodontitis Receives: Other: Observation of suPAR plasma and salivary levels | |
| Cardiovascular disease | Patients with cardiovascular disease Receives: Other: Observation of suPAR plasma and salivary levels | |
| Periodontitis + cardiovascular disease | Patients with Periodontitis + cardiovascular disease Receives: Other: Observation of suPAR plasma and salivary levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical attachment level
evaluation of changes in clinical attachment level
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start15 Feb 2015
- Primary completion21 Sep 2018
- Study completion25 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DisturbanceStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Messina
- Sponsor type
- University, hospital or other
- Collaborators
- University of Catania
- Responsible party
- Principal investigator, Gaetano Isola, DDS, PhD, University of Messina
- Investigators
- Giovanni Matarese, Study chair, University of Messina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04335344
- Sponsor's protocol ID
- 11-18-18
- Status last verified
- Apr 2020
- First submitted
- 2 Apr 2020
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD, all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Plasma and Salivary suPAR in Periodontitis and CVD Patients
- ClinicalTrials.gov ID
- NCT04335344
- Acronym / sponsor ID
- 11-18-18
- Conditions
- Metabolic Disturbance, Periodontal Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- University of MessinaUniversity, hospital or other
- Collaborators
- University of Catania
- Study start
- 15 Feb 2015 (actual)
- Primary completion
- 21 Sep 2018 (actual)
- Study completion
- 25 Feb 2020 (actual)
- First posted
- 6 Apr 2020 (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.
soluble urokinase-type plasminogen activator receptor (suPAR) plays a key role in endothelial function and may be a link for the known interaction of periodontitis and cardiovascular disease (CVD). The investigators compared the impact of gingival health, periodontitis (CP), CHD or of both diseases (CP+CHD) on saliva and serum suPAR levels.
Detailed description
The aim of this study was to evaluate a possible association between both saliva and serum suPAR levels in patients with CP and with CVD and if the serum suPAR levels are mediated by serum CRP.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | – | Other: Observation of suPAR plasma and salivary levelsHealthy patients |
| Periodontitis | – | Other: Observation of suPAR plasma and salivary levelsPatients with periodontitis |
| Cardiovascular disease | – | Other: Observation of suPAR plasma and salivary levelsPatients with cardiovascular disease |
| Periodontitis + cardiovascular disease | – | Other: Observation of suPAR plasma and salivary levelsPatients with Periodontitis + cardiovascular disease |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy subjects (n=33) and patients with periodontitis (n=35), CVD (n=34), and a combination of periodontitis + CVD (n=34) were enrolled in the present study.
Key inclusion criteria (4 listed)
- Presence of at least 15 teeth
- CP with a minimum of 40% of sites with a clinical attachment level (CAL) ≥2mm and probing depth (PD) ≥4mm;
- Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs
- Presence of ≥40% sites with bleeding on probing (BOP)
Key exclusion criteria (6 listed)
- Intake of contraceptives
- Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study
- Status of pregnancy or lactation
- Previous history of excessive drinking
- Allergy to local anaesthetic
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 |
|---|---|---|
| Observation of suPAR plasma and salivary levelsEvaluation of suPAR plasma level and correlation of plasma suPAR levels with periodontal and cardiovascular disease | Other | Cardiovascular disease, Control, Periodontitis, Periodontitis + cardiovascular disease |
Primary outcome
Clinical attachment level
Time frame: 1-year
evaluation of changes in clinical attachment level
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 7 Apr 2020.
- Individual participant dataSharing planned: Yes. all collected IPD, all IPD that underlie results in a publication
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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.
Giovanni Matarese study chair
University of Messina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Disturbance and Periodontal Diseases, run by University of Messina 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 4 inclusion and 6 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 7 Apr 2020. 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?
Clinical attachment level (time frame: 1-year). 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 7 Apr 2020.