RecruitingNot Applicable

Efficacy of 3D-Printed Mouth Splints

United States10 participantsStarted 2025-02-21

Plain-language 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.

Who can participate

Age range2 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

What they're measuring

Change in Oral Aperture measurements

Timeframe: Baseline to Month 3

Trial details

NCT IDNCT06801535

SponsorWake Forest University Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Study Coordinator

3367164171 csuggs@wakehealth.edu

View on ClinicalTrials.gov More Microstomia trials