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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

StatusEnrolling by Invitation
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 4, 2025 (before its estimated December 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT07264218
Lead Sponsor Hangang Sacred Heart Hospital
Conditions
(from sponsor)
Burn, 3D Printing, Microstomia, Split Thickness Skin Graft
Related terms Burns, Microstomia
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov