# Randomized Trial of non-Surgical Therapy and Oral Hygiene Instruction to Reduce Risk of Infective Endocarditis

> **NIH NIH UG3** · CAROLINAS MEDICAL CENTER · 2022 · $660,849

## Abstract

Project Summary
Infective endocarditis (IE) has high morbidity and mortality. Upwards of 30% of cases of IE are
caused by oral bacterial species that enter the bloodstream and colonize heart valves. Frequent
episodes of bacteremia from dental biofilm (plaque) are likely to be significant risk factors for
development of IE. Our prior work demonstrates that: 1) there are only informal guidelines for
prevention in 90% of people at risk for IE; 2) tooth brushing results in a high incidence of
bacteremia of IE-causing species; 3) the risk of such bacteremia increases with the level of dental
plaque and calculus present; and 4) patients with IE have a higher burden of dental plaque and
calculus than matched non-IE controls. Although millions of people in the U.S. are at risk for IE
because of pre-existing cardiac conditions, there are no prospective studies or solid evidence to
show that improving oral hygiene reduces bacteremia from routine daily activities (e.g.,
toothbrushing). Evidence does show, however, that bacteremia is a strong surrogate marker for
risk of IE. The lack of supporting data means that longstanding speculation about the importance
of oral hygiene and gingival inflammation as risk factors for IE have had too little impact on
practice guidelines on prevention, clinical practice, or funding for preventive care. The next step
is to determine if professional scaling and oral hygiene instruction significantly reduce the
incidence and duration of IE-causing bacteremia from toothbrushing. We plan to enroll 320 people
at risk for IE into a clinical trial. Enrollees will be randomized to professional scaling and oral
hygiene instruction versus routine oral care. We will test the steps in the hypothesized causal
pathway from improved oral hygiene to decreased bacteremia from IE-causing species by: 1)
determining the impact of professional scaling and oral hygiene instruction on the incidence and
duration of bacteremia with IE-causing species during and following toothbrushing; 2) comparing
oral hygiene and gingival health measures between randomized treatment groups and testing
whether improvement in these measures is associated with reduced incidence and duration of
bacteremia from toothbrushing; and 3) determining the degree to which reduction in bacteremia
incidence and duration, and improvement in oral hygiene and gingival inflammation scores, are
maintained following the intervention. This study will provide novel, important data to inform the
healthcare community, guideline committees, and health funding agencies of the importance of
improving oral hygiene and reducing gingival inflammation as primary preventive measures for all
people at risk of IE.

## Key facts

- **NIH application ID:** 10348489
- **Project number:** 1UG3DE031250-01
- **Recipient organization:** CAROLINAS MEDICAL CENTER
- **Principal Investigator:** PETER B LOCKHART
- **Activity code:** UG3 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $660,849
- **Award type:** 1
- **Project period:** 2022-02-01 → 2023-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10348489

## Citation

> US National Institutes of Health, RePORTER application 10348489, Randomized Trial of non-Surgical Therapy and Oral Hygiene Instruction to Reduce Risk of Infective Endocarditis (1UG3DE031250-01). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/10348489. Licensed CC0.

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