TerminatedNot Applicable

Periodontal and Cardiovascular Diseases Project

Stopped: Study population was insufficient to provide an adequate pool of patients. All included patients were treated and followed, but the overall desired sample size was not achieve

Spain36 participantsStarted 2016-02-19

Plain-language summary

The purpose of this study is to investigate whether basic periodontal therapy aim to reduce subgingival levels of Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans, has an impact on the vascular function of patients suffering from established cardiovascular disease.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * (1) patients with established cardiovascular disease (unstable angina or stroke in the previous 3 to 12 months, and left ventricular ejection fraction ≥50%); * (2) diagnosis of moderate to severe generalized periodontitis (PD\>5mm and marginal bone loss \>30% on at least 50% of the teeth, according to Tonetti et al. 2007); * (3) presence of at least 3 teeth per quadrant. Exclusion Criteria: * (1) periodontal treatment in the previous year; * (2) antibiotic intake in the previous 3 months; * (3) smokers of ≥10 cigarettes per day; * (4) pregnancy or breast feeding; * (5) diabetes mellitus types I or II, with glycosylated hemoglobin values \>7; * (6) necrotizing periodontal diseases; * (7) HIV infection; * (8) chronic intake of NSAID

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Flow mediated dilation of the brachial artery

Timeframe: Day 0 (Baseline), Day 90, Day 180

Trial details

NCT IDNCT02716259

SponsorUniversidad Complutense de Madrid

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-02-19

View on ClinicalTrials.gov More Periodontitis trials

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.