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Efficacy of 3D-Printed Mouth Splints

NCT06801535 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-12-17

No results posted yet for this study

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

Interventions

DEVICE

Splint

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

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Christopher Runyan, MD, PhD · Wake Forest University Health Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-21
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06801535 on ClinicalTrials.gov