Tuesday, April 23, 2024 4/23/2024

3D Dynamic and Patient-Centered Outcomes of Facial Reanimation Surgery in Patients with Facial Paralysis

Award Number: R01DE028565
ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Patients with facial paralysis have an obvious facial disability that includes facial disfigurement and impairment in soft tissue movements, particularly in facial expressive behaviors. Management requires a tailored and, at times, disparate approach to correct the facial disability ranging from non-surgical interventions to facial reanimation surgery. Surgeons’ plan treatment based on measurements made from 2D images and subjective grading of the patient’s face, both of which are limited in scope and dimension. Recently, we demonstrated the utility of novel, landmark-based, 3D dynamic and static quantitative (objective) measures and modeling comparisons for the evaluation of facial disability in patients with facial paralysis and tracked their recovery over a 12-week period (NIH DE 025295). Thus, the overall goal of this prospective, observational study is to compare the facial disability and perception outcomes of facial reanimation surgeries in patients with extensive and permanent, unilateral paralysis using the refined 3D analysis, and compare patient-centered outcomes of facial appearance, well-being, and satisfaction using validated questionnaires. There will be three groups of surgery patients who will have a free gracilis muscle transfer. Group 1 will have muscle transfer driven by the trigeminal nerve (nV); Group 2 will have muscle transfer driven by a cross-face nerve graft (nVII); and Group 3 will have muscle transfer driven by dual innervation using both nerves. The data from these groups will be compared with previously collected data from historical controls. The null hypothesis to be tested is that there will be no difference in the impact of the surgical change on facial disability (primary HO) or on patient perception (secondary HO) effected by the three different surgical approaches for facial/smile reanimation after controlling for patient characteristics. Specific Aim 1. To assess (1) the differences in facial disability (impairment and disfigurement) before surgery among the three surgery groups and compared to a historical control group (control data collected during the precursor R21 grant); (2) the changes in facial disability that occur at 5 and 18 months after surgery among the three groups; and (3) the differences in persistent facial disability 18 months after surgery among the surgery groups and compared to the control group. Outcomes: 3D measures of facial soft tissue displacement, velocity, and disfigurement (form). Specific Aim 2. To compare (1) the differences in self-perceptions of facial appearance/well-being and patient satisfaction among the three surgery groups and control group before surgery; (2) the changes in self perceptions from before to 18 months after surgery among the surgery groups; and (3) the differences in self perceptions among the surgery groups and the control group at 18 months after surgery. Outcomes: Qualitative measures using the Facial Clinimetric Evaluation Scale (FACE), Medical Outcomes Study Short Form Scale (SF-36) and the Pre/Postsurgical Perception and Satisfaction Scale (PSP). Specific Aim 3. To compare the objective, 3D, quantitative assessments of patients’ facial disability with surgeons’ currently used subjective and 2D assessments for the same patients in order to assess the differential information provided by the 3D assessment approach (such as area affected, severity of defect, and extent of resolution of disability) that is not available from the current subjective and 2D assessments. Outcomes: 3D measures of facial soft tissue displacement, velocity, and 3D disfigurement (form); and surgeons’ subjective assessments from eFACE rating scale and 2D measures from Face-Gram/Emotrics software.


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 = $576,767 )
2024	2024	OHIO STATE UNIVERSITY, THE	1960 KENNY RD	COLUMBUS	OH	43210	FRANKLIN	USA	Oral Diseases and Disorders Research	000	4	1/16/2024	NON-COMPETING CONTINUATION	$576,767
														Subtotal = $576,767

Issue Date FY: 2023 ( Subtotal = $630,379 )
2023	2023	OHIO STATE UNIVERSITY, THE	1960 KENNY RD	COLUMBUS	OH	43210	FRANKLIN	USA	Oral Diseases and Disorders Research	003	3	2/16/2023	NON-COMPETING CONTINUATION	$63,038
2023	2023	OHIO STATE UNIVERSITY, THE	1960 KENNY RD	COLUMBUS	OH	43210	FRANKLIN	USA	Oral Diseases and Disorders Research	002	3	1/9/2023	NON-COMPETING CONTINUATION	$567,341
2023	2022	OHIO STATE UNIVERSITY, THE	1960 KENNY RD	COLUMBUS	OH	43210	FRANKLIN	USA	Oral Diseases and Disorders Research	001	2	11/10/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$450,646
2023	2021	TRUSTEES OF TUFTS COLLEGE	136 HARRISON AVE	BOSTON	MA	02111	SUFFOLK	USA	Oral Diseases and Disorders Research	000	1	11/10/2022	NEW	-$450,646
														Subtotal = $630,379

Issue Date FY: 2022 ( Subtotal = $671,464 )
2022	2022	OHIO STATE UNIVERSITY, THE	1960 KENNY RD	COLUMBUS	OH	43210	FRANKLIN	USA	Oral Diseases and Disorders Research	002	2	4/22/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$46,058
2022	2022	OHIO STATE UNIVERSITY, THE	1960 KENNY RD	COLUMBUS	OH	43210	FRANKLIN	USA	Oral Diseases and Disorders Research	001	2	3/3/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$625,406
2022	2021	TRUSTEES OF TUFTS COLLEGE	136 HARRISON AVE	BOSTON	MA	02111	SUFFOLK	USA	Oral Diseases and Disorders Research	000	1	2/24/2022	NEW	$0
														Subtotal = $671,464

Issue Date FY: 2021 ( Subtotal = $675,080 )
2021	2021	TRUSTEES OF TUFTS COLLEGE	136 HARRISON AVE	BOSTON	MA	02111	SUFFOLK	USA	Oral Diseases and Disorders Research	000	1	2/16/2021	NEW	$675,080
														Subtotal = $675,080

Grand Total All Awards = $2,553,690

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3D Dynamic and Patient-Centered Outcomes of Facial Reanimation Surgery in Patients with Facial Paralysis

Award Number: R01DE028565

ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

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