Periodontitis, AdultNCT03297749
Genetic Variants and Oxidative Stress as Links Between Periodontitis and Metabolic Syndrome
An observational study of Periodontitis, Adult and Metabolic Syndrome, run by University College, London at 2 sites in 2 countries.
Trial summary
The aim of this study is to investigate the systemic impact of periodontitis in patients with Metabolic Syndrome, by assessing measures of sub-clinical atherosclerosis and cardiovascular risk, microbial factors and host genetic variants, and to study the possible effect of mediators of inflammation and oxidative… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Periodontitis, Adult, Metabolic Syndrome
- How many people
- 102 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jul 2015to 31 Dec 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 18 to 75 years
- All sexes
- Adult, Older adult
Study population: Subjects with metabolic syndrome will be recruited from outpatients attending the Internal Medicine Unity at the University of Catania.
Who may be able to join
- Caucasian ethnicity
- Age 18- 75
- Diagnosis of metabolic syndrome
- Presence of at least 12 teeth
Who cannot join
- Pregnancy
- Presence of infectious diseases such as hepatitis and HIV
- Use of non-steroidal anti-inflammatory drugs (excluding low-dose aspirin) within one month prior to the baseline visit
- Use of systemic antibiotics within three months prior to the baseline visit
- Antibiotic pre-medication required for the performance of periodontal examination
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
The aim of this study is to investigate the systemic impact of periodontitis in patients with Metabolic Syndrome, by assessing measures of sub-clinical atherosclerosis and cardiovascular risk, microbial factors and host genetic variants, and to study the possible effect of mediators of inflammation and oxidative stress as links between the two conditions.
Read the detailed description
This is a cross-sectional study. 102 patients with metabolic syndrome will be recruited and will have periodontal and dental examination for diagnosis of caries and periodontal diseases. They will undergo blood, saliva, GCF and subgingival plaque sampling and a series of tests on cardiovascular disease, including measures of pulse-wave velocity,carotid intima-media thickness and echocardiography assessment. Statistical analysis will assess associations between dental diagnoses and metabolic, cardiovascular, inflammatory, genetic, microbial and cardiovascular risk outcomes.
- Conditions
- Periodontitis, Adult, Metabolic Syndrome
- Being tested
- Observational study (no intervention)
- Medical subject headings
- Chronic Periodontitis, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study (no intervention)Other
Also called No interventions
No interventions
What is being measured
The primary outcome is the main question the study is designed to answer.
pulse wave velocity
Measured: baseline
oxidative stress
Measured: baseline
carotid intima-media thickness
Measured: baseline
genetic variants
Measured: baseline
left ventricular mass
Measured: baseline
Secondary outcomes (2)
inflammatory markers
Measured: baseline
subgingival microbes
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start1 Jul 2015
- Primary completion30 Sep 2017
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periodontitis, AdultStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- 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
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- University of Catania
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03297749
- Sponsor's protocol ID
- 4242/01
- Status last verified
- Sep 2017
- First submitted
- 26 Sep 2017
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nibali L, Donos N, Terranova V, Di Pino A, Di Marca S, Ferrara V, Pisano M, Scicali R, Rabuazzo AM, Purrello F, Malatino L. Left ventricular geometry and periodontitis in patients with the metabolic syndrome. Clin Oral Investig. 2019 Jun;23(6):2695-2703. doi: 10.1007/s00784-018-2667-8. Epub 2018 Oct 22.
PubMed 30350134
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Variants and Oxidative Stress as Links Between Periodontitis and Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT03297749
- Acronym / sponsor ID
- 4242/01
- Conditions
- Periodontitis, Adult, Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- University of Catania
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 29 Sep 2017 (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.
The aim of this study is to investigate the systemic impact of periodontitis in patients with Metabolic Syndrome, by assessing measures of sub-clinical atherosclerosis and cardiovascular risk, microbial factors and host genetic variants, and to study the possible effect of mediators of inflammation and oxidative stress as links between the two conditions.
Detailed description
This is a cross-sectional study. 102 patients with metabolic syndrome will be recruited and will have periodontal and dental examination for diagnosis of caries and periodontal diseases. They will undergo blood, saliva, GCF and subgingival plaque sampling and a series of tests on cardiovascular disease, including measures of pulse-wave velocity,carotid intima-media thickness and echocardiography assessment. Statistical analysis will assess associations between dental diagnoses and metabolic, cardiovascular, inflammatory, genetic, microbial and cardiovascular risk outcomes.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects with metabolic syndrome will be recruited from outpatients attending the Internal Medicine Unity at the University of Catania.
Key inclusion criteria (4 listed)
- Caucasian ethnicity
- Age 18- 75
- Diagnosis of metabolic syndrome
- Presence of at least 12 teeth
Key exclusion criteria (5 listed)
- Pregnancy
- Presence of infectious diseases such as hepatitis and HIV
- Use of non-steroidal anti-inflammatory drugs (excluding low-dose aspirin) within one month prior to the baseline visit
- Use of systemic antibiotics within three months prior to the baseline visit
- Antibiotic pre-medication required for the performance of periodontal examination
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 |
|---|---|---|
| Observational study (no intervention)Also: No interventionsNo interventions | Other | – |
Primary outcome
pulse wave velocity
Time frame: baseline
oxidative stress
Time frame: baseline
carotid intima-media thickness
Time frame: baseline
genetic variants
Time frame: baseline
left ventricular mass
Time frame: baseline
2 secondary outcomes
inflammatory markers
Time frame: baseline
subgingival microbes
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
- Derived from this study: PubMed 30350134Nibali L, Donos N, Terranova V, Di Pino A, Di Marca S, Ferrara V, Pisano M, Scicali R, Rabuazzo AM, Purrello F, Malatino L. Left ventricular geometry and periodontitis in patients with the metabolic syndrome. Clin Oral Investig. 2019 Jun;23(6):2695-2703. doi: 10.1007/s00784-018-2667-8. Epub 2018 Oct 22.
- 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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis, Adult and Metabolic Syndrome, run by University College, London at 2 sites in 2 countries.
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 5 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: status not confirmed, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, United Kingdom. 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?
Results are not available in the source record.
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?
pulse wave velocity (time frame: baseline). 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?
On the ClinicalTrials.gov record for NCT03297749, which also lists 1 linked publication.
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 26 Oct 2017.