Efficacy of 3D-Printed Mouth Splints

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor: Wake Forest University Health Sciences
Study ID: NCT06801535
Status: Recruiting

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Conditions

Microstomia

Eligibility Criteria

Sex: ALL
Age: 2 Years - 99 Years
Healthy Volunteers: Not accepted

Interventions

Splint — DEVICE
Patients will use the splint at home 3 times daily for 10 minutes per session for 3 months total.

Study Details

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.

Key Dates

Start date: Feb 21, 2025
Status verified: Dec 2025
Primary completion: Dec 31, 2026
Completion: Dec 31, 2026

Study Design

Enrollment: 10 participants (estimated)
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Arms

Experimental: Treatment
Assess the impact of the 3D-printed mouth splint on oral aperture measurements over a 3-month period.

Primary Outcome Measure

Change in Oral Aperture measurements [ Time Frame: Baseline to Month 3 ]

Central Contacts

Study Coordinator
3367164171
[email protected]

Locations (1)

Facility	City	State	ZIP	Site coordinators
Wake Forest University Health Sciences	Winston-Salem	North Carolina	27157	Caleb Suggs, CCRP [email protected] 336-713-4339 Christopher Runyan, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site

Wake Forest University Health Sciences· Winston-Salem, NC