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Comprehensive Periodontal Therapy to Improve Oral and Cardiometabolic Health in Prediabetes

Award Number: UG3DE035059
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: 09/01/2026
PERIOD OF PERFORMANCE END DATE: 08/31/2027

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Comprehensive Periodontal Therapy to Improve Oral and Cardiometabolic Health in Prediabetes - PROJECT SUMMARY: Type 2 Diabetes (T2D) and periodontitis are prevalent and strongly associated. These associations are bidirectional and likely causal. Furthermore, it is plausible that dysbiotic oral microbial communities may cause insulin resistance and impaired glucose regulation prior to diabetes onset, through a variety of mechanisms. Previous randomized trials demonstrate that periodontal therapy improves glycemic control among people with diabetes, but no randomized trial in the U.S. has studied this among people with prediabetes. If oral dysbiosis contributes to diabetes, early interventions to restore or maintain eubiosis in people with prediabetes – a high-risk group for diabetes development – would likely have dual oral and metabolic benefits. Importantly, conventional periodontal treatment trials have provided non-surgical periodontal therapy to patients with rather advanced stages of periodontitis, often without subsequent maintenance visits, and have led to suboptimal periodontal treatment outcomes and only transient reductions in periodontal inflammation. We propose a randomized intervention study among individuals with periodontitis and prediabetes, to test whether comprehensive periodontal therapy (CPT) arrests the progression of dysglycemia and periodontal deterioration. We will use a pragmatic, novel, “cohort multiple randomized controlled trial” (CM-RCT) design to test our hypothesis. Patients will be recruited from the Mayo Clinic Health System and Apple Tree Dental (ATD) Centers. Electronic Health Record (EHR)-based recruitment, enrollment, and monitoring will be achieved via the Rochester Epidemiology Project (REP), an EHR linkage system built to accelerate clinical research. n=176 individuals will be randomized to receive an offer of complete financial coverage for CPT. A control group of n=1,824 will be identified to continue receiving standard of care (SOC). Annualized change in oral health and glycated hemoglobin A1c (A1c) trajectories will be monitored in both groups via routine clinical care encounters captured in the EHR. CPT will be offered starting as early as Stage I periodontitis, and will involve multiple treatment sessions including periodontal surgery, if needed, local application of antibiotics at residual pockets, and periodontal maintenance visits every two or three months as determined necessary by the treating dentist. The CM-RCT design is a novel adaptation to classical large pragmatic RCTs meant to address limitations related to recruitment challenges, generalizability, and ethical concerns in classical designs. The current study is responsive to two NIDCR strategic priorities: 1) “Integrate oral and general health and understand bidirectional consequences of oral inflammation to systemic illness at distant sites” (priority #1); and 2) “Translate and implement, by leveraging resources to test intervention-based trials that can be tested in real world settings (priority #3). The current study can concurrently inform etiology, clinical practice, and policy decisions around dental insurance coverage standards.


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: 2026 ( Subtotal = $575,803 )
2026	2026	MAYO CLINIC	200 1ST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Oral Diseases and Disorders Research	000	1	8/14/2026	NEW	$575,803
														Subtotal = $575,803

Grand Total All Awards = $575,803

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Comprehensive Periodontal Therapy to Improve Oral and Cardiometabolic Health in Prediabetes

Award Number: UG3DE035059

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: 09/01/2026

PERIOD OF PERFORMANCE END DATE: 08/31/2027

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