Efficacy of 3D-Printed Mouth Splints
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Splint.
- Who it may be relevant to
- Registry conditions: Microstomia. Basic parameters: 2 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of 3D-Printed Mouth Splints in the Management of Microstomia in Burn Patients
Overview
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.
Detailed description
Microstomia, or reduced oral aperture, is a debilitating condition that can arise after burn injuries, particularly to the face. This condition severely impacts oral hygiene, nutrition, speech, and overall quality of life. Current management strategies often rely on therapy, surgical intervention, and splinting to improve mouth opening and functionality. However, there is a lack of accessibility to good mouth splinting devices. 3D-printed, dynamic splints offer may offer a superior and cost-effective solution that can be tailored to the patient's anatomy while allowing for at-home treatment. Sizing can also be adjusted to fit essentially any aperture since, including pediatrics. This device is intended for use at home, supported by teaching and follow-up provided by occupational therapists (OTs).
Interventions
- Device Splint
Patients will use the splint at home 3 times daily for 10 minutes per session for 3 months total.
Primary outcome measures
- Change in Oral Aperture measurements [Time frame: Baseline to Month 3]
Secondary outcome measures (2)
- Change in Mouth Impairment and Disability Assessment (MIDA) Scores [Time frame: Baseline to Month 3]
- Change in Patient Satisfaction Scores [Time frame: Baseline to Month 3]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Wake Forest University Health Sciences — Winston-Salem
Publications
- Couture MA, Calva V, de Oliveira A, LaSalle L, Forget N, Nedelec B. Development and clinimetric evaluation of the mouth impairment and disability assessment (MIDA). Burns. 2018 Jun;44(4):980-994. doi: 10.1016/j.burns.2017.10.024. Epub 2018 Feb 7. PMID 29428487
Identifiers
NCT: NCT06801535 · IRB00124137