Using 3D-printed mouth splints to improve oral function
Efficacy of 3D-Printed Mouth Splints in the Management of Microstomia in Burn Patients
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 2 Years to 99 Years |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT06801535 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients aged 2 to 99 years with documented microstomia resulting from burn injuries.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Winston-Salem, North Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.