Efficacy of 3D-Printed Mouth Splints

NCT06801535 | Recruiting DMC FDA Device

• 1 other identifier: IRB00124137
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Microstomia

Keywords

cleft lip and palate; craniocarpotarsal dysplasia; dental hygiene

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Mouth Impairment and Disability Assessment (MIDA) Scores

  Baseline to Month 3

• Change in Patient Satisfaction Scores

  Baseline to Month 3

Study Arms (1)

Treatment

EXPERIMENTAL

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

Device: Splint

Interventions

Splint DEVICE

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

Treatment

Eligibility Criteria

• Age: 2 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Related Publications (1)

• 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 RESULT

Related Links

• Design published for public use:

MeSH Terms

Conditions

Microstomia; Cleft Lip; Freeman-Sheldon syndrome

Interventions

Splints

Condition Hierarchy (Ancestors)

Mouth Abnormalities; Mouth Diseases; Stomatognathic Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lip Diseases

Intervention Hierarchy (Ancestors)

External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices

Study Officials

• Christopher Runyan, MD, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Coordinator

CONTACT

3367164171; csuggs@wakehealth.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: January 30, 2025
• Study Start: February 21, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)