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.

Public Health Relevance

Patients with facial paralysis have a severe facial soft tissue disability that includes impairments in movements, particularly facial expressive behaviors. We have developed and refined novel 3D dynamic and static quantitative (objective) measures and dynamic modeling comparisons for characterization of facial disability and outcomes of treatment in patients with facial paralysis. Thus, the goals of this study are to determine outcomes of mid-facial reanimation surgeries in patients with more extensive and permanent, unilateral, paralysis of varied etiology and presentation using patient-centered 3D objective facial measures/modeling and patient-centered measures of facial appearance and well-being.

Agency
National Institute of Health (NIH)
Institute
National Institute of Dental & Craniofacial Research (NIDCR)
Type
Research Project (R01)
Project #
1R01DE028565-01A1
Application #
10211825
Study Section
Behavioral Medicine, Interventions and Outcomes Study Section (BMIO)
Program Officer
Iida, Hiroko
Project Start
2021-02-16
Project End
2025-01-31
Budget Start
2021-02-16
Budget End
2022-01-31
Support Year
1
Fiscal Year
2021
Total Cost
Indirect Cost
Name
Tufts University
Department
Dentistry
Type
Schools of Dentistry/Oral Hygn
DUNS #
039318308
City
Boston
State
MA
Country
United States
Zip Code