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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Assess the impact of the 3D-printed mouth splint on oral aperture measurements over a 3-month period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Splint | Device | Patients will use the splint at home 3 times daily for 10 minutes per session for 3 months total. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Oral Aperture measurements | Difference in measurements of oral aperture from Baseline visit to Final visit will be reported - Oral aperture measurements taken with calipers | Baseline to Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mouth Impairment and Disability Assessment (MIDA) Scores | The mouth impairment and disability assessment (MIDA) has a 28 item self-report portion, divided into four subscales, completed by the patient and an impairment-based section completed by the burn therapist. The Mouth Impairment and Disability Assessment (MIDA) scale typically ranges from a low score indicating minimal impairment to a high score representing significant disability, with the exact range depending on the specific version of the scale and how individual items are scored; however, most versions will have a total score that can be interpreted within a broader range of severity, with higher scores signifying greater impairment. This assessment is scored from 0 to 64. Zero is equivalent to no difficulty and 64 would indicate the highest level of difficulty. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Coordinator | Contact | 3367164171 | csuggs@wakehealth.edu |
| Name | Affiliation | Role |
|---|---|---|
| Christopher Runyan, MD, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29428487 | Result | 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. |
| Label | URL |
|---|---|
| Design published for public use: | View source |
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| ID | Term |
|---|---|
| D008865 | Microstomia |
| D002971 | Cleft Lip |
| C535483 | Freeman-Sheldon syndrome |
| ID | Term |
|---|---|
| D009056 | Mouth Abnormalities |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D018640 | Stomatognathic System Abnormalities |
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| ID | Term |
|---|---|
| D013165 | Splints |
| ID | Term |
|---|---|
| D016267 | External Fixators |
| D009984 | Orthopedic Fixation Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
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Assess the impact of the 3D-printed mouth splint on oral aperture measurements over a 3-month period.
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| Baseline to Month 3 |
| Change in Patient Satisfaction Scores | Total patient satisfaction scored on survey at weekly visits to be reported from 0 to 23. 0 equivalent to no satisfaction and 23 is the highest level of satisfaction. | Baseline to Month 3 |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008047 | Lip Diseases |
| D004864 |
| Equipment and Supplies |
| D053831 | Surgical Fixation Devices |