Metabolic DiseaseNCT04030286
Evaluation of Malondialdehyde in Periodontal and Cardiovascular Disease
An observational study of Metabolic Disease, run by University of Messina at 1 site in Italy.
Trial summary
Malondialdehyde (MDA) plays a key role in endothelial function and may be a link for the known interaction of periodontitis and coronary heart disease (CHD). The investigators compared the impact of gingival health, periodontitis (CP), CHD or of both diseases (CP+CHD) on saliva and serum MDA levels. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Disease
- What is being tested?
- Observation
- How many people
- 133 participants
- Where
- 1 siteItaly
- Study dates
- 3 Jan 2014to 1 Apr 2019
- How long will I take part?
- 1 Year
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 32 healthy subjects, 34 patients with CP, 33 patients with CHD and 34 patients with CP and CHD. Lipid profile and levels of MDA and C-reactive protein (CRP) were evaluated.
Who may be able to join
- Presence of at least twenty 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: Analysis of Serum and Salivary Malondialdehyde and Lipid Profile Levels in Patients With Periodontal and Cardiovascular Diseases
Malondialdehyde (MDA) plays a key role in endothelial function and may be a link for the known interaction of periodontitis and coronary heart disease (CHD). The investigators compared the impact of gingival health, periodontitis (CP), CHD or of both diseases (CP+CHD) on saliva and serum MDA levels.
Read the detailed description
The aim of this study was to evaluate a possible association between both saliva and serum MDA levels in patients with CP and with CHD and if the serum MDA levels are mediated by serum CRP
- Conditions
- Metabolic Disease
- Being tested
- Observation
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Evaluation of Malondialdehyde level and correlation of Malondialdehyde level with periodontal and cardiovascular disease
| Study group | Role | What they receive |
|---|---|---|
| Control | Healthy patients Receives: Other: Observation | |
| Periodontitis | Patients with periodontal disease Receives: Other: Observation | |
| Cardiovascular | Patients with cardiovascular disease Receives: Other: Observation | |
| Periodontitis+Cardiovascular | Patients with both periodontal and cardiovascular disease Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Malondialdehyde levels
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 posted23 Jul 2019
- Study start3 Jan 2014
- Primary completion9 Sep 2018
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DiseaseStudies 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
- 133 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Messina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaetano Isola, DDS, PhD, University of Messina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04030286
- Sponsor's protocol ID
- 16-12
- Status last verified
- Jul 2019
- First submitted
- 19 Jul 2019
- Last updated
- 23 Jul 2019
- 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 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Serum and Salivary Malondialdehyde and Lipid Profile Levels in Patients With Periodontal and Cardiovascular Diseases
- ClinicalTrials.gov ID
- NCT04030286
- Acronym / sponsor ID
- 16-12
- Conditions
- Metabolic Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- University of MessinaUniversity, hospital or other
- Study start
- 3 Jan 2014 (actual)
- Primary completion
- 9 Sep 2018 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 23 Jul 2019 (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.
Malondialdehyde (MDA) plays a key role in endothelial function and may be a link for the known interaction of periodontitis and coronary heart disease (CHD). The investigators compared the impact of gingival health, periodontitis (CP), CHD or of both diseases (CP+CHD) on saliva and serum MDA levels.
Detailed description
The aim of this study was to evaluate a possible association between both saliva and serum MDA levels in patients with CP and with CHD and if the serum MDA levels are mediated by serum CRP
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | – | Other: ObservationHealthy patients |
| Periodontitis | – | Other: ObservationPatients with periodontal disease |
| Cardiovascular | – | Other: ObservationPatients with cardiovascular disease |
| Periodontitis+Cardiovascular | – | Other: ObservationPatients with both periodontal and cardiovascular disease |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 32 healthy subjects, 34 patients with CP, 33 patients with CHD and 34 patients with CP and CHD. Lipid profile and levels of MDA and C-reactive protein (CRP) were evaluated.
Key inclusion criteria (5 listed)
- Presence of at least twenty 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 |
|---|---|---|
| ObservationEvaluation of Malondialdehyde level and correlation of Malondialdehyde level with periodontal and cardiovascular disease | Other | Cardiovascular, Control, Periodontitis, Periodontitis+Cardiovascular |
Primary outcome
Malondialdehyde levels
Time frame: 1 year
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 23 Jul 2019.
- 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.
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?
An observational study of Metabolic Disease, 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 5 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 23 Jul 2019. 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?
Malondialdehyde levels (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 23 Jul 2019.