Clinical trial NCT06801535: Efficacy of 3D-Printed Mouth Splints
Official title: Efficacy of 3D-Printed Mouth Splints in the Management of Microstomia in Burn Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Microstomia
Keywords: cleft lip and palate
craniocarpotarsal dysplasia
dental hygiene
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2025-01-30
Enrollment: 10
Sex: ALL
Minimum age (years): 2
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Assess the impact of the 3D-printed mouth splint on oral aperture measurements over a 3-month period.
Primary purpose: TREATMENT

Brief summary: 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.

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).

Eligibility criteria: 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).

Primary outcomes:
measure: Change in Oral Aperture measurements
timeFrame: Baseline to Month 3
Secondary outcomes:
measure: Change in Mouth Impairment and Disability Assessment (MIDA) Scores
timeFrame: Baseline to Month 3
measure: Change in Patient Satisfaction Scores
timeFrame: Baseline to Month 3
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Christopher Runyan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Couture MA, Calva V, de Oliveira A, LaSalle L, Forget N, Nedelec B. Development and clinimetric evaluation of the mouth impairment and disability assessment (MIDA). Burns. 2018 Jun;44(4):980-994. doi: 10.1016/j.burns.2017.10.024. Epub 2018 Feb 7.