Wake Forest University Health Sciences
The study will investigate the effectiveness of a 3D-printed mouth splint designed to increase dimensions of oral aperture and reduce disability associated with mouth contractures. The validated Mouth Impairment and Disability Assessment (MIDA) survey will be used to objectively measure patient progress in functionality and quality of life.
Microstomia
Splint
NA
Microstomia, or reduced oral aperture, is a debilitating condition that can arise after burn injuries, particularly to the face. This condition severely impacts oral hygiene, nutrition, speech, and overall quality of life. Current management strategies often rely on therapy, surgical intervention, and splinting to improve mouth opening and functionality. However, there is a lack of accessibility to good mouth splinting devices. 3D-printed, dynamic splints offer may offer a superior and cost-effective solution that can be tailored to the patient's anatomy while allowing for at-home treatment. Sizing can also be adjusted to fit essentially any aperture since, including pediatrics. This device is intended for use at home, supported by teaching and follow-up provided by occupational therapists (OTs).
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 10 participants |
| Masking : | NONE |
| Primary Purpose : | TREATMENT |
| Official Title : | Efficacy of 3D-Printed Mouth Splints in the Management of Microstomia in Burn Patients |
| Actual Study Start Date : | 2025-02-21 |
| Estimated Primary Completion Date : | 2025-12 |
| Estimated Study Completion Date : | 2025-12 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 2 Years to 99 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157