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Efficacy of 3D-Printed Mouth Splints

Efficacy of 3D-Printed Mouth Splints in the Management of Microstomia in Burn Patients

Who can join

Ages 2 to 99 · All sexes

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).

About the study

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.

What is being tested

• Splint (device)

Sponsor: Wake Forest University Health Sciences · Participants: 10 · Started: Feb 21, 2025

Contact the study team

• Study Coordinator · Phone: 3367164171

Official record on ClinicalTrials.gov — NCT06801535

Locations in the U.S.

Conditions

• Cleft Lip and Palate

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.