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Long-term Oral Complications of an Established Head and Neck Cancer Cohort- 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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PROJECT SUMMARY/ABSTRACT Most head and neck cancer (HNC) patients receive high-dose radiation therapy (RT), which has significant, sometimes life-long, adverse effects on oral and maxillofacial tissues. Damage to salivary glands frequently leads to hyposalivation, increasing the risk of dental caries and tooth loss post-radiation. Furthermore, radiation impairs the 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. Consequently, HNC 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. A multi-center prospective cohort study, Clinical Registry of Dental Outcomes in Head and Neck Cancer Patients (OraRad), was established to examine the incidence of oral complications after RT and associated risk factors in HNC patients. The OraRad cohort of 572 participants was followed for 24 months with incidence and risk factors of short-term oral complications identified. The overall objective of the current proposal is to assess OraRad participants at 7 years post-RT and identify the long-term incidence and risk factors of oral complications in this cohort. We will accomplish this objective by pursuing the following specific aims: 1) Determine the long-term incidence of dental caries, periodontal disease, tooth loss and osteoradionecrosis, up to 7 years after RT for HNC patients and 2) Determine the risk factors associated with high and low incidence of long-term oral complications and develop a multiple variable model of risk. We will accomplish these aims by having current OraRad participants return for a clinical oral examination at about 7 years post- RT. We anticipate 350 long-term OraRad survivors will be evaluated at this follow-up visit. The proposed research is innovative because this is the first prospective multi-center study with a large enough sample to identify risk factors associated with long-term adverse dental outcomes in HNC patients after modern RT. Our strong data on the incidence and risk factors of oral complications for the initial OraRad 24-month study period 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 RT for HNC.


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	003	11	8/29/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$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	2023	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Oral Diseases and Disorders Research	002	11	5/29/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
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 ) (Continued on the next page)
Grand Total All Awards = $16,829,492

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Long-term Oral Complications of an Established Head and Neck Cancer Cohort- 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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