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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

NCT07264218 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-12-04

No results posted yet for this study

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.

Conditions

  • Burn
  • 3D Printing
  • Microstomia
  • Split Thickness Skin Graft

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.

Sponsors & Collaborators

  • Hangang Sacred Heart Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-05
Primary Completion
2025-12-30
Completion
2026-01-30

Countries

  • South Korea

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 NCT07264218 on ClinicalTrials.gov