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Recruiting Not applicable Interventional

Efficacy of 3D-Printed Mouth Splints

NCT06801535
Conditions
Microstomia
Interventions
Splint
Device
Lead sponsor
Wake Forest University Health Sciences
Other
Eligibility
2 Years to 99 Years
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2026
U.S. locations
1
States / cities
Winston-Salem, North Carolina
Conditions
Arthrogryposis, Craniofacial Abnormalities, Posttraumatic Stress Disorder, Depressive Disorder
Interventions
PTSD Checklist-Specific, Modified Flanagan Quality of Life Scale, Center for Epidemiologic Studies Depression Scale, Functional Enquiry Form, Strength, Joint ROM, Girth and Length Measurements, Study Physical Examination, PTSD, Depression, and FSS-Focused Examination, Freeman-Sheldon Specific Quality of Life Survey, Lactate, Glucose, and Adenosine Triphosphate Blood Levels
Other
Lead sponsor
Freeman-Sheldon Research Group, Inc.
Other
Eligibility
Not listed
Enrollment
6 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2017
U.S. locations
1
States / cities
Buckhannon, West Virginia
Conditions
Freeman-Sheldon Syndrome, Arthrogryposis Distal Type 2A, Whistling Face Syndrome, Craniocarpotarsal Dysplasia, Craniocarpotarsal Dystrophy, Freeman-Sheldon Syndrome Variant, Sheldon-Hall Syndrome, Arthrogryposis Distal Type 2B, Gordon Syndrome, Arthrogryposis Distal Type 3, Arthrogryposis Distal Type 1, Arthrogryposis, Distal, Type 1A, Arthrogryposis Distal Type 1B, Arthrogryposis, Distal, Craniofacial Abnormalities, Arthrogryposis
Interventions
PTSD Checklist-Civilian (PCL-C), Modified Flanagan Quality of Life Scale, Center for Epidemiologic Studies Depression Scale (CES-D), Functional Enquiry (or Review of Systems) Form, Study of Therapeutic Outcomes and Practices in Freeman-Sheldon Syndrome (STOP-FSS) Questionnaire, FSRG Semi-Structured Quality of Life Interview (FSRG SSQLI), Medical Records Review
Other
Lead sponsor
Freeman-Sheldon Research Group, Inc.
Other
Eligibility
Not listed
Enrollment
2 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2022
U.S. locations
1
States / cities
Buckhannon, West Virginia
Conditions
Arthrogryposis, Craniofacial Abnormalities
Interventions
Lactate, Glucose, and Adenosine Triphosphate Blood Levels, Physiological Stress Test, Functional Enquiry Form, Strength, Joint ROM, Girth and Length Measurements, Study Physical Examination, Observational Gait Analysis, Mental Health Interview
Other · Procedure
Lead sponsor
Freeman-Sheldon Research Group, Inc.
Other
Eligibility
Not listed
Healthy volunteers
Accepts healthy volunteers
Timeline
2014 – 2022
U.S. locations
1
States / cities
Buckhannon, West Virginia
Conditions
Freeman-Burian Syndrome, Freeman-Sheldon Syndrome, Whistling Face Syndrome, Sheldon-Hall Syndrome, Freeman-Sheldon Syndrome Variant, Arthrogryposis Distal Type 1, Arthrogryposis Distal Type 3, Gordon Syndrome
Interventions
Guided Health History for Freeman-Burian Syndrome Questionnaire, Freeman-Burian syndrome Semi-Structured Quality of Life Interview, Medical Records Review, PTSD Checklist for DSM-5, Modified Flanagan Quality of Life Scale, Center for Epidemiologic Studies Depression Scale, Review of Systems, FACE-Q | Craniofacial - Appearance of the Face, FACE-Q | Craniofacial - Appearance Distress, FACE-Q | Craniofacial - Facial Function
Other
Lead sponsor
Dufresne, Craig, MD, PC
Other
Eligibility
Not listed
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2023
U.S. locations
1
States / cities
Fairfax, Virginia