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Intensive gum disease treatment failed as a measure of secondary prevention for stroke survivors in the "stroke belt" of the U.S., a randomized study found.

Deep cleaning and other upgraded dental care did not significantly reduce the primary composite endpoint of stroke, myocardial infarction (MI), and death at 12 months compared with standard periodontal treatment (7.7% vs 12.3%; HR 0.65, 95% CI 0.30-1.38), reported Souvik Sen, MD, MPH, of the University of South Carolina in Columbia.

However, both intensive and standard treatment arms in the PREMIERS study experienced lower-than-expected recurrent events, given a nearly 25% event rate among historical controls, Sen told the audience at the International Stroke Conference hosted by the American Stroke Association.

Moreover, he noted that the trial participants who had more dental visits over the course of the study -- up to five sessions in a year -- tended to have fewer primary outcome events. Notably, the trial had been disrupted for 3 months at the beginning of the COVID-19 pandemic, a period in which patients had to skip dental visits due to the aerosol-generating procedures involved.

Sen emphasized that "oral health is important" and proposed further investigation of periodontal treatment in a bigger study.

Prior work has suggested that oral bacteria invading into gum tissue can set off systemic inflammation that results in increased atheroma and plaque instability, ultimately putting people at increased risk of MI and stroke.

PREMIERS was conducted at Sen's institution as well as the University of North Carolina. Investigators recruited adult patients with recent ischemic stroke or transient ischemic attack and periodontal disease for adaptive randomization -- by race, socioeconomic status, stroke severity, and recurrent stroke risk -- to standard or intensive gum disease treatment.

There were 280 people randomized out of 1,209 screened over 4 years. This cohort had a mean age of 60 years; 90% were men; Black people accounted for nearly three-quarters of the group.

Standard treatment consisted of regular cleaning in-office and care at home. Intensive treatment comprised deep cleaning, extraction of "hopeless teeth," and local application of antibiotics at dental visits, as well as at-home use of an electric toothbrush, mouth wash, and air flosser.

The two study arms were balanced with the exception that there was more diabetes in the intensive treatment group (51% vs 37%).

Sen reported that diastolic blood pressure (BP) dropped modestly by 12 months for both standard (89 to 84 mm Hg, P=0.02) and intensive treatment groups (89 to 85 mm Hg, P=0.04), which also shared a modest rise in HDL cholesterol (the latter finding significant only for the standard treatment group's change from 53 to 59 mg/dL, P=0.03).

No changes in systolic BP, LDL cholesterol, triglycerides, glycemic control, or carotid intima-media thickness were observed.

Adverse events such as sepsis and dental bleeding were similarly rare between study arms. The one case of infective endocarditis in the intensive treatment was judged to be unrelated because the pathogen was not found in the patient's oral cavity.

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