Efficacy of 3D-Printed Mouth Splints
Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Jan 24, 2025
Trial Information
Current as of September 09, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new 3D-printed mouth splint that aims to help people with a condition called microstomia, which is a narrowing of the mouth that can occur after burn injuries. The goal of the study is to see if this splint can make it easier for patients to open their mouths wider and improve their daily life. Researchers will use a survey called the Mouth Impairment and Disability Assessment (MIDA) to track how well the treatment is working for participants.
The trial is currently looking for participants aged 2 to 99 years who have been diagnosed with microstomia due to burn injuries. To be eligible, patients need to be able to follow the home exercises that come with the splint and attend follow-up visits. However, individuals who have difficulty understanding or performing the exercises, or those with other conditions that could affect mouth movement, may not be included. If you or someone you know might be interested, this could be an opportunity to help improve mouth function and overall quality of life.
Gender
ALL
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).
About Wake Forest University Health Sciences
Wake Forest University Health Sciences is a leading academic research institution dedicated to advancing healthcare through innovative clinical trials and translational research. With a strong emphasis on multidisciplinary collaboration, the organization leverages its extensive expertise in medical research, patient care, and education to develop and evaluate new therapies and interventions. Committed to improving patient outcomes and public health, Wake Forest University Health Sciences fosters a dynamic environment for scientific inquiry, engaging in a wide range of clinical studies that address pressing health challenges. Through its rigorous methodologies and ethical standards, the institution aims to contribute significantly to the medical field and enhance the quality of life for diverse populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Winston Salem, North Carolina, United States
Patients applied
Trial Officials
Christopher Runyan, MD, PhD
Principal Investigator
Wake Forest University Health Sciences
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported