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Clinical Registry of Dental Outcomes in Head and Neck Cancer Patients (ORARAD)

Award Number: U01DE022939
ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

Group Awards By Issue Date FY or Funding FY:

View Award Abstract

Most head and neck (H&N) cancer patients receive high-dose radiation therapy (RT), often combined with surgery or chemotherapy. Unfortunately, high-dose RT has significant adverse effects on oral and maxillofacial tissues. Salivary gland damage frequently causes hyposalivation, increasing risk of dental caries and tooth loss. Furthermore, radiation impairs ability of bone to heal, leading to a life-long risk of osteoradionecrosis (ORN), which presents as exposed intraoral bone and is often precipitated by dental extractions. Therefore, these patients are caught in a vicious circle, being at higher risk of needing dental extractions, but with extractions to be avoided post-RT due to the risk for ORN. To attempt to reduce such complications, pre-RT dental assessment is considered a best practice. However, pre-RT dental management practices vary widely and are largely based on expert opinion, due to lack of adequate evidence. Available data are mostly from studies using older RT modalities without concurrent chemotherapy. Current use of Intensity-Modulated Radiation Therapy (IMRT) has potential to reduce severity/incidence of oral complications. Conversely, concurrent use of chemotherapy with RT may aggravate toxicities. However, definitive data do not exist on the extent or severity of oral complications due to current therapeutic regimens, or on risk factors for adverse outcomes. Also, some oral complications, such as periodontal changes, are particularly understudied in this population. This constitutes an important gap in knowledge because it hampers the pre- and post-RT dental management of these patients. The objective of this research is to collect data on dental outcomes in H&N cancer patients receiving modern RT modalities and identify risk factors for adverse outcomes. We will accomplish these objectives by pursuing the following specific aims: 1) Measure 2-year changes in dental caries and periodontal disease, and 2-year rates of tooth loss, after modern RT regimens, and assess risk factors for caries increment, progression of periodontal disease, and tooth loss. 2) Measure 6-month and 18- month changes in stimulated whole salivary flow after modern RT regimens, and assess risk factors for decreased salivary flow. 3) Measure the incidence of exposed intraoral bone after modern RT regimens, and assess risk factors for exposed intraoral bone. We will accomplish these aims by completing our ongoing NIH- funded multi-center prospective cohort study, which has already enrolled 568 of the necessary 575 subjects. Dental and other oral outcomes, and data on risk factors, are recorded in H&N cancer patients before start of RT and every 6 months for 2 years after RT. The proposed research is innovative because this is the first multi-center study with a large enough sample size to identify risk factors associated with adverse dental outcomes in H&N cancer patients after modern RT. Our strong preliminary data clearly demonstrate the feasibility of achieving these aims. This study is highly significant because it will directly provide data to facilitate evidence-based dental management of patients receiving current modalities of H&N RT.


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: 2024 ( Subtotal = $0 )
2024	2023	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Oral Diseases and Disorders Research	001	11	2/22/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$1,324,386
2024	2022	THE CHARLOTTE-MECKLENBURG HOSPITAL AUTHORITY	1000 BLYTHE BLVD	CHARLOTTE	NC	28203	MECKLENBURG	USA	Oral Diseases and Disorders Research	000	10	2/22/2024	NON-COMPETING CONTINUATION	-$1,324,386
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $1,219,959 )
2023	2023	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Oral Diseases and Disorders Research	004	11	7/11/2023	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	-$1,581
2023	2023	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Oral Diseases and Disorders Research	003	11	7/3/2023	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$1,221,540
2023	2021	THE CHARLOTTE-MECKLENBURG HOSPITAL AUTHORITY	1000 BLYTHE BLVD	CHARLOTTE	NC	28203	MECKLENBURG	USA	Oral Diseases and Disorders Research	002	9	11/10/2022	COMPETING CONTINUATION	$801,407
2023	2020	THE CHARLOTTE-MECKLENBURG HOSPITAL AUTHORITY	1000 BLYTHE BLVD	CHARLOTTE	NC	28203	MECKLENBURG	USA	Oral Diseases and Disorders Research	001	8	11/10/2022	NON-COMPETING CONTINUATION	-$443,665
2023	2019	THE CHARLOTTE-MECKLENBURG HOSPITAL AUTHORITY	1000 BLYTHE BLVD	CHARLOTTE	NC	28203	MECKLENBURG	USA	Oral Diseases and Disorders Research	000	7	11/10/2022	NON-COMPETING CONTINUATION	-$357,742
														Subtotal = $1,219,959

Issue Date FY: 2022 ( Subtotal = $1,409,114 )
2022	2022	CHARLOTTE-MECKLENBURG HOSPITAL AUTHORITY, THE	1000 BLYTHE BOULEVARD	CHARLOTTE	NC	28203	MECKLENBURG	USA	Oral Diseases and Disorders Research	001	10	8/29/2022	NON-COMPETING CONTINUATION	$1,409,114
2022	2022	CHARLOTTE-MECKLENBURG HOSPITAL AUTHORITY, THE	1000 BLYTHE BOULEVARD	CHARLOTTE	NC	28203	MECKLENBURG	USA	Oral Diseases and Disorders Research	002	10	9/19/2022	NON-COMPETING CONTINUATION	$0
2022	2020	CHARLOTTE-MECKLENBURG HOSPITAL AUTHORITY, THE	1000 BLYTHE BOULEVARD	CHARLOTTE	NC	28203	MECKLENBURG	USA	Oral Diseases and Disorders Research	000	8	1/4/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,409,114

Issue Date FY: 2021 ( Subtotal = $1,242,008 )
2021	2021	CHARLOTTE-MECKLENBURG HOSPITAL AUTHORITY, THE	1000 BLYTHE BOULEVARD	CHARLOTTE	NC	28203	MECKLENBURG	USA	Oral Diseases and Disorders Research	001	9	6/16/2021	COMPETING CONTINUATION	$1,242,008
2021	2020	CHARLOTTE-MECKLENBURG HOSPITAL AUTHORITY, THE	1000 BLYTHE BOULEVARD	CHARLOTTE	NC	28203	MECKLENBURG	USA	Oral Diseases and Disorders Research	000	8	3/26/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,242,008

Issue Date FY: 2020 ( Subtotal = $443,665 )
2020	2020	CHARLOTTE-MECKLENBURG HOSPITAL AUTHORITY, THE	1000 BLYTHE BOULEVARD	CHARLOTTE	NC	28203	MECKLENBURG	USA	Oral Diseases and Disorders Research	000	8	7/20/2020	NON-COMPETING CONTINUATION	$443,665
														Subtotal = $443,665

Issue Date FY: 2019 ( Subtotal = $1,618,120 )
2019	2019	CHARLOTTE-MECKLENBURG HOSPITAL AUTHORITY, THE	1000 BLYTHE BOULEVARD	CHARLOTTE	NC	28203	MECKLENBURG	USA	Oral Diseases and Disorders Research	002	7	6/26/2019	NON-COMPETING CONTINUATION	$1,618,120
2019	2019	CHARLOTTE-MECKLENBURG HOSPITAL AUTHORITY, THE	1000 BLYTHE BOULEVARD	CHARLOTTE	NC	28203	MECKLENBURG	USA	Oral Diseases and Disorders Research	003	7	9/19/2019	NON-COMPETING CONTINUATION	$0
2019	2018	CHARLOTTE-MECKLENBURG HOSPITAL AUTHORITY, THE	1000 BLYTHE BOULEVARD	CHARLOTTE	NC	28203	MECKLENBURG	USA	Oral Diseases and Disorders Research	001	6	2/3/2019	COMPETING CONTINUATION	$148,333
2019	2017	CHARLOTTE-MECKLENBURG HOSPITAL AUTHORITY, THE	1000 BLYTHE BOULEVARD	CHARLOTTE	NC	28203	MECKLENBURG	USA	Oral Diseases and Disorders Research	000	5	2/3/2019	SUPPLEMENT FOR EXPANSION	-$148,333
														Subtotal = $1,618,120

Issue Date FY: 2018 ( Subtotal = $2,079,075 )
2018	2018	CHARLOTTE-MECKLENBURG HOSPITAL AUTHORITY, THE	1000 BLYTHE BOULEVARD	CHARLOTTE	NC	28203	MECKLENBURG	USA	Oral Diseases and Disorders Research	008	6	7/5/2018	COMPETING CONTINUATION	$2,079,075
2018	2017	CHARLOTTE-MECKLENBURG HOSPITAL AUTHORITY, THE	1000 BLYTHE BOULEVARD	CHARLOTTE	NC	28203	MECKLENBURG	USA	Oral Diseases and Disorders Research	003	5	6/15/2018	SUPPLEMENT FOR EXPANSION	$0
2018	2017	CHARLOTTE-MECKLENBURG HOSPITAL AUTHORITY, THE	1000 BLYTHE BOULEVARD	CHARLOTTE	NC	28203	MECKLENBURG	USA	Oral Diseases and Disorders Research	007	5	6/29/2018	SUPPLEMENT FOR EXPANSION	$0
2018	2016	CHARLOTTE-MECKLENBURG HOSPITAL AUTHORITY, THE	1000 BLYTHE BOULEVARD	CHARLOTTE	NC	28203	MECKLENBURG	USA	Oral Diseases and Disorders Research	006	5	6/29/2018	SUPPLEMENT FOR EXPANSION	$0
2018	2016	CHARLOTTE-MECKLENBURG HOSPITAL AUTHORITY, THE	1000 BLYTHE BOULEVARD	CHARLOTTE	NC	28203	MECKLENBURG	USA	Oral Diseases and Disorders Research	005	5	6/29/2018	EXTENSION WITH OR WITHOUT FUNDS	$0
2018	2016	CHARLOTTE-MECKLENBURG HOSPITAL AUTHORITY, THE	1000 BLYTHE BOULEVARD	CHARLOTTE	NC	28203	MECKLENBURG	USA	Oral Diseases and Disorders Research	004	5	6/28/2018	SUPPLEMENT FOR EXPANSION	$0
2018	2016	CHARLOTTE-MECKLENBURG HOSPITAL AUTHORITY, THE	1000 BLYTHE BOULEVARD	CHARLOTTE	NC	28203	MECKLENBURG	USA	Oral Diseases and Disorders Research	000	5	6/15/2018	EXTENSION WITH OR WITHOUT FUNDS	$0
2018	2016	CHARLOTTE-MECKLENBURG HOSPITAL AUTHORITY, THE	1000 BLYTHE BOULEVARD	CHARLOTTE	NC	28203	MECKLENBURG	USA	Oral Diseases and Disorders Research	001	5	6/15/2018	SUPPLEMENT FOR EXPANSION	$0
2018	2016	CHARLOTTE-MECKLENBURG HOSPITAL AUTHORITY, THE	1000 BLYTHE BOULEVARD	CHARLOTTE	NC	28203	MECKLENBURG	USA	Oral Diseases and Disorders Research	002	5	6/15/2018	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $2,079,075

Issue Date FY: 2017 ( Subtotal = $500,000 )
2017	2017	CHARLOTTE-MECKLENBURG HOSPITAL AUTHORITY, THE	1000 BLYTHE BOULEVARD	CHARLOTTE	NC	28203	MECKLENBURG	USA	Oral Diseases and Disorders Research	005	5	8/22/2017	SUPPLEMENT FOR EXPANSION	-$500,000
2017	2017	CHARLOTTE-MECKLENBURG HOSPITAL AUTHORITY, THE	1000 BLYTHE BOULEVARD	CHARLOTTE	NC	28203	MECKLENBURG	USA	Oral Diseases and Disorders Research	004	5	8/17/2017	SUPPLEMENT FOR EXPANSION	$500,000
2017	2017	CHARLOTTE-MECKLENBURG HOSPITAL AUTHORITY, THE	1000 BLYTHE BOULEVARD	CHARLOTTE	NC	28203	MECKLENBURG	USA	Oral Diseases and Disorders Research	006	5	8/28/2017	SUPPLEMENT FOR EXPANSION	$500,000
2017	2016	CHARLOTTE-MECKLENBURG HOSPITAL AUTHORITY, THE	1000 BLYTHE BOULEVARD	CHARLOTTE	NC	28203	MECKLENBURG	USA	Oral Diseases and Disorders Research	003	5	2/9/2017	EXTENSION WITH OR WITHOUT FUNDS	$1,858,312
2017	2015	CHARLOTTE-MECKLENBURG HOSPITAL AUTHORITY, THE	1000 BLYTHE BOULEVARD	CHARLOTTE	NC	28203	MECKLENBURG	USA	Oral Diseases and Disorders Research	001	4	2/9/2017	NON-COMPETING CONTINUATION	-$1,736,990
2017	2014	CHARLOTTE-MECKLENBURG HOSPITAL AUTHORITY, THE	1000 BLYTHE BOULEVARD	CHARLOTTE	NC	28203	MECKLENBURG	USA	Oral Diseases and Disorders Research	000	3	2/9/2017	NON-COMPETING CONTINUATION	-$54,567
2017	2014	CHARLOTTE-MECKLENBURG HOSPITAL AUTHORITY, THE	1000 BLYTHE BOULEVARD	CHARLOTTE	NC	28203	MECKLENBURG	USA	Oral Diseases and Disorders Research	002	3	2/9/2017	SUPPLEMENT FOR EXPANSION	-$66,755
														Subtotal = $500,000

Issue Date FY: 2016 ( Subtotal = $1,623,953 )
2016	2016	CAROLINAS MEDICAL CENTER	P.O. BOX 32861	CHARLOTTE	NC	28232	MECKLENBURG	USA	Oral Diseases and Disorders Research	001	5	6/1/2016	SUPPLEMENT FOR EXPANSION	$54,518
2016	2016	CAROLINAS MEDICAL CENTER	P.O. BOX 32861	CHARLOTTE	NC	28232	MECKLENBURG	USA	Oral Diseases and Disorders Research	000	5	5/27/2016	EXTENSION WITH OR WITHOUT FUNDS	$1,454,033
2016	2016	CAROLINAS MEDICAL CENTER	P.O. BOX 32861	CHARLOTTE	NC	28232	MECKLENBURG	USA	Oral Diseases and Disorders Research	002	5	6/1/2016	SUPPLEMENT FOR EXPANSION	$115,402
														Subtotal = $1,623,953

Issue Date FY: 2015 ( Subtotal = $1,736,990 )
2015	2015	CAROLINAS MEDICAL CENTER	P.O. BOX 32861	CHARLOTTE	NC	28232	MECKLENBURG	USA	Oral Diseases and Disorders Research	000	4	4/17/2015	NON-COMPETING CONTINUATION	$1,736,990
														Subtotal = $1,736,990

Issue Date FY: 2014 ( Subtotal = $1,884,520 )
2014	2014	CAROLINAS MEDICAL CENTER	P.O. BOX 32861	CHARLOTTE	NC	28232	MECKLENBURG	USA	Oral Diseases and Disorders Research	001	3	9/4/2014	SUPPLEMENT FOR EXPANSION	$66,755
2014	2014	CAROLINAS MEDICAL CENTER	P.O. BOX 32861	CHARLOTTE	NC	28232	MECKLENBURG	USA	Oral Diseases and Disorders Research	000	3	5/21/2014	NON-COMPETING CONTINUATION	$1,817,765
														Subtotal = $1,884,520

Grand Total All Awards = $16,829,492

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Clinical Registry of Dental Outcomes in Head and Neck Cancer Patients (ORARAD)

Award Number: U01DE022939

ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

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