Recruiting

3D-Printed Mouth Splints

Sponsor:

Wake Forest University Health Sciences

Code:

NCT06801535

Conditions

Microstomia

Eligibility Criteria

Sex: All

Age: 2 - 70+

Healthy Volunteers: Not accepted

Interventions

Splint

Study Details

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

Study ID

NCT06801535

Start date

Feb 21, 2025

Status verified date

Dec, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment

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

Interventions

Splint

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Study Coordinator

3367164171csuggs@wakehealth.edu

Locations

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Caleb Suggs, CCRP

336-713-4339csuggs@wakehealth.edu

Principal Investigator:

Christopher Runyan, MD, PhD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Dec 17, 2025

Last verified

Dec, 2025

Keywords

  • cleft lip and palate
  • craniocarpotarsal dysplasia
  • dental hygiene

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2025-12-17.