Efficacy of 3D-Printed Mouth Splints
Purpose
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.
Condition
- Microstomia
Eligibility
- Eligible Ages
- Between 2 Years and 99 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Patients 2 years to 99 years of age with documented microstomia following burn injuries. - Ability to comply with prescribed home exercises and follow-up visits.
Exclusion Criteria
- Cognitive or physical inability to perform the prescribed exercises. - Inability of a caretaker to be able to deliver therapy daily. - Concomitant conditions that may significantly affect oral aperture (e.g., temporomandibular joint (TMJ) disorders).
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Assess the impact of the 3D-printed mouth splint on oral aperture measurements over a 3-month period.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Treatment |
Assess the impact of the 3D-printed mouth splint on oral aperture measurements over a 3-month period. |
|
Recruiting Locations
Winston-Salem 4499612, North Carolina 4482348 27157
More Details
- Status
- Recruiting
- Sponsor
- Wake Forest University Health Sciences
Detailed Description
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).