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ENROLLING BY INVITATION
NCT07264218
NA

Clinical Effectiveness of a Patient-tailored Orthosis Based on 3-dimensional (3D) Scanner Modeling and 3D Printing Technology for Microstomia Caused by Burns : Pilot Study

Sponsor: Hangang Sacred Heart Hospital

View on ClinicalTrials.gov

Summary

Mircostomia is not clearly defined in terms of size, but is diagnosed when it causes difficulty in eating, pronounciation, or maintaining oral hygiene. Although various treatments have been applied to microstomia caused by mouth contracture after facial burns, there is no established protocol yet. This study aimed to confirm the clinical usefulness of patient-customized mouthpiece using 3D scanner modeling and printing technology.Each participant's mouths were scanned using a 3D scanner (Peel 3, Peel 3D, Canada). The scanned model was imported into the modeling software (Geomagic Design X, 3D Systems, USA). After modeling the mouthpiece to fit the maximum horizontal and vertical length of the mouth and the thickness of the lips, it was manufactured using a 3D printer (Form 4B Medical, Formlabs, USA). The participant was advised to wear the appliance throughout the day except during meals. As a primary outcome, the vertical and horizontal distances of the mouth were measured before and after wearing the patient-customized mouthpiece for 2 months. As secondary outcomes, the biological scar properties, the Vancouver Scar Scale (VSS), and the Patient and Observer Scar Assessment Scale (POSAS) scores were evaluated.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2025-07-05

Completion Date

2026-01-30

Last Updated

2025-12-04

Healthy Volunteers

No

Interventions

OTHER

patient's tailored mouthpiece fitting

Manufacturing patient-tailored mouthpiece using 3D modeling technology. The participant was advised to wear the appliance throughout the day except during meals. The maximaum horizontal and vertical distances were measured every two weeks to assess whether the mouthpiece had the ability to stretch against the scar. If the patient found it easy to wear or there was no stretching effect, the patient-tailored mouthpiece was remade.

Locations (1)

Hangang Scared Heart Hospital IRB

Seoul, South Korea