Using 3D-printed mouth splints to improve oral function
Official title: Efficacy of 3D-Printed Mouth Splints in the Management of Microstomia in Burn Patients
Run by Wake Forest University Health Sciences · NCT06801535 · Data updated 2026-11-12
This study is testing if custom 3D-printed mouth splints can help people with small mouths from burn injuries eat and speak better while making their daily lives easier.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 2 Years to 99 Years |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Status | Recruiting |
| Started | February 21, 2025 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | December 17, 2025 |
| Trial ID | NCT06801535 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients aged 2 to 99 years with documented microstomia resulting from burn injuries.
✕Probably not a fit
Patients with cognitive or physical limitations that prevent them from performing prescribed exercises or those with significant concomitant conditions affecting oral aperture may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effectiveness of 3D-printed mouth splints designed to increase the dimensions of the oral aperture and reduce disability associated with microstomia, particularly following burn injuries. The approach involves creating customized splints that can be adjusted for individual anatomy, allowing for at-home treatment supported by occupational therapists. The Mouth Impairment and Disability Assessment (MIDA) survey will be utilized to objectively measure improvements in functionality and quality of life for participants. This innovative method aims to provide a cost-effective solution for a condition that severely impacts daily living.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance the quality of life for patients with microstomia by improving oral function and hygiene.
How similar studies have gone: While the use of 3D-printed devices in medical applications is gaining traction, this specific approach to treating microstomia is relatively novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion 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).
Where it's running
-
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States Recruiting
Study contacts
- Principal investigator: Christopher Runyan, MD, PhD — Wake Forest University Health Sciences
- Study coordinator: Study Coordinator
- Email: csuggs@wakehealth.edu
- Phone: 3367164171
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.