An interventional study of Splint in Microstomia, sponsored by Wake Forest University Health Sciences. Recruiting at 1 site in United States. Open to participants aged 2 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-12-17.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Treatment
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).
168 studies on the registry are indexed under Cleft Lip; 51 are open to participants now.
This study's planned enrollment of 10 is below the median of 30 across 116 interventional studies indexed under Cleft Lip.
Browse Cleft Lip studies →Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
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Exclusion Criteria:
Assess the impact of the 3D-printed mouth splint on oral aperture measurements over a 3-month period.
Device: Splint
Patients will use the splint at home 3 times daily for 10 minutes per session for 3 months total.
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
Time frame: Baseline to Month 3
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.
Time frame: 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.
Time frame: Baseline to Month 3
Plan to share: No
Started Feb 2025 (actual). Primary completion is estimated for Dec 2026, 22 months after the start.
Of 64 non-industry interventional studies with no phase under Cleft Lip, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 33. This study's planned 22 months is close to that.
Counting every sponsor, half of 65 studies reached it within 22 months; a quarter within 15 and three quarters within 33.
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