Efficacy of 3D-Printed Mouth Splints (3DMS)

Efficacy of 3D-Printed Mouth Splints in the Management of Microstomia in Burn Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Microstomia
• Intervention / Treatment: Device: Splint

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).

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Study Coordinator; Phone Number: 3367164171; Email: csuggs@wakehealth.edu

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest University Health Sciences
      • Contact: Caleb Suggs, CCRP; Phone Number: 336-713-4339; Email: csuggs@wakehealth.edu
      • Principal Investigator: Christopher Runyan, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Christopher Runyan, MD, PhD, Wake Forest University Health Sciences

Publications and helpful links

General 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.

Helpful Links

• Design published for public use:

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 24, 2025
• First Submitted That Met QC Criteria: January 24, 2025
• First Posted (Actual): January 30, 2025

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: cleft lip and palate; dental hygiene; craniocarpotarsal dysplasia
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Lip Diseases; Mouth Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cleft Lip; Microstomia; Freeman-Sheldon syndrome; External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices; Splints
• Other Study ID Numbers: IRB00124137

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No