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

Award Number: UH3DE031250
ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 02/14/2023
PERIOD OF PERFORMANCE END DATE: 01/31/2028

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


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $1,160,779 )
2025	2025	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Oral Diseases and Disorders Research	000	5	2/13/2025	NON-COMPETING CONTINUATION	$1,044,701
2025	2025	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Oral Diseases and Disorders Research	001	5	7/9/2025	NON-COMPETING CONTINUATION	$116,078
														Subtotal = $1,160,779

Issue Date FY: 2024 ( Subtotal = $1,148,034 )
2024	2024	THE CHARLOTTE-MECKLENBURG HOSPITAL AUTHORITY	1000 BLYTHE BLVD	CHARLOTTE	NC	28203	MECKLENBURG	USA	Oral Diseases and Disorders Research	001	3	4/8/2024	NON-COMPETING CONTINUATION	-$1,056,068
2024	2024	THE CHARLOTTE-MECKLENBURG HOSPITAL AUTHORITY	1000 BLYTHE BLVD	CHARLOTTE	NC	28203	MECKLENBURG	USA	Oral Diseases and Disorders Research	000	3	2/16/2024	NON-COMPETING CONTINUATION	$1,056,069
2024	2024	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Oral Diseases and Disorders Research	006	4	8/29/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$430,430
2024	2024	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Oral Diseases and Disorders Research	003	4	6/12/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$95,353
2024	2024	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Oral Diseases and Disorders Research	002	4	4/9/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$1,052,680
2024	2024	THE CHARLOTTE-MECKLENBURG HOSPITAL AUTHORITY	1000 BLYTHE BLVD	CHARLOTTE	NC	28203	MECKLENBURG	USA	Oral Diseases and Disorders Research	005	3	8/29/2024	NON-COMPETING CONTINUATION	-$1
2024	2023	THE CHARLOTTE-MECKLENBURG HOSPITAL AUTHORITY	1000 BLYTHE BLVD	CHARLOTTE	NC	28203	MECKLENBURG	USA	Oral Diseases and Disorders Research	004	2	8/29/2024	EXTENSION WITH OR WITHOUT FUNDS	-$430,429
														Subtotal = $1,148,034

Issue Date FY: 2023 ( Subtotal = $1,284,743 )
2023	2023	CHARLOTTE-MECKLENBURG HOSPITAL AUTHORITY, THE	1000 BLYTHE BOULEVARD	CHARLOTTE	NC	28203	MECKLENBURG	USA	Oral Diseases and Disorders Research	000	2	2/14/2023	EXTENSION WITH OR WITHOUT FUNDS	$1,179,697
2023	2023	THE CHARLOTTE-MECKLENBURG HOSPITAL AUTHORITY	1000 BLYTHE BLVD	CHARLOTTE	NC	28203	MECKLENBURG	USA	Oral Diseases and Disorders Research	001	2	6/1/2023	EXTENSION WITH OR WITHOUT FUNDS	$105,046
2023	2023	CHARLOTTE-MECKLENBURG HOSPITAL AUTHORITY, THE	1000 BLYTHE BOULEVARD	CHARLOTTE	NC	28203	MECKLENBURG	USA	Oral Diseases and Disorders Research	002	2	7/18/2023	EXTENSION WITH OR WITHOUT FUNDS	$0
														Subtotal = $1,284,743

Grand Total All Awards = $3,593,556

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

Award Number: UH3DE031250

ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 02/14/2023

PERIOD OF PERFORMANCE END DATE: 01/31/2028

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