Efficacy of 3D-Printed Mouth Splints (3DMS)

Wake Forest University (WFU)

Status

Enrolling

Conditions

Microstomia

Treatments

Device: Splint

Study type

Interventional

Funder types

Other

Identifiers

NCT06801535

IRB00124137

Details and patient eligibility

About

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.

Full 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).

Enrollment

10 estimated patients

Sex

All

Ages

2 to 99 years old

Volunteers

No Healthy Volunteers

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).