3D-Printed Mouth Splints for Small Mouth
(3DMS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new 3D-printed mouth splint designed to help individuals with small mouths due to burn injuries open their mouths wider and improve their quality of life. The goal is to determine if these splints can ease daily activities like eating and speaking. Individuals who struggle to open their mouths due to burn-related scarring may be suitable for the trial. Participants must follow a home exercise plan and attend follow-up visits. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance daily life for burn survivors.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What prior data suggests that this 3D-printed mouth splint is safe?
Research has shown that 3D-printed mouth splints are generally safe. Studies indicate that these splints use materials with low levels of monomers, which can be harmful in large amounts. This composition makes them suitable for clinical use. Tests assessing material safety for the body also confirm the safety of these splints. Designed for comfort, they can be worn for extended periods without causing harm. Overall, the materials in 3D-printed splints are well-tolerated and typically do not cause adverse reactions.12345
Why are researchers excited about this trial?
Researchers are excited about 3D-printed mouth splints for small mouths because they offer a customizable and precise fit that traditional splints, typically made from pre-formed materials, can't match. These splints are created using advanced 3D-printing technology, allowing them to be tailored to the unique shape of each patient's mouth, potentially enhancing comfort and effectiveness. This innovative approach could improve oral aperture measurements more rapidly and comfortably compared to standard options, which often involve more generalized and less adaptable solutions.
What evidence suggests that this 3D-printed mouth splint is effective for increasing oral aperture?
Research has shown that 3D-printed mouth splints could help treat small mouth conditions. These splints widen the mouth opening and reduce issues caused by tightness. Studies have found that 3D printing allows precise control over the splint’s thickness and shape, improving fit and function. Previous research suggests these splints are safer than traditional methods due to fewer harmful materials. Although direct data on mouth tightness is limited, the success of this technology in similar dental applications supports its potential effectiveness. Participants in this trial will receive the 3D-printed mouth splint to assess its impact on oral aperture measurements over a 3-month period.14678
Who Is on the Research Team?
Christopher Runyan, MD, PhD
Principal Investigator
Wake Forest University Health Sciences
Are You a Good Fit for This Trial?
This trial is for individuals with a small mouth opening, often due to scarring or contractures, who have undergone bone marrow transplants. Specific eligibility details are not provided but typically include certain health and demographic criteria.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use the 3D-printed mouth splint at home, with support from occupational therapists, to improve oral aperture over a 3-month period
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- 3D-Printed Mouth Splints
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor