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 | Enrolling By Invitation DMC

• 1 other identifier: HangangSHH-21
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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; Split Thickness Skin Graft; Microstomia

Keywords

microstomia; mouth; split thickness skin graft; burn; 3D scanner modeling

Outcome Measures

Primary Outcomes (1)

• mouth size measurement

  vertical mouth opening range wea recorded as the measurement in millimeters from the inner border of the medial top lip to the inner border of the medial lower lip whilist in the stretched position. Horizontal mouth opening range was recorded as the measurement in millimeters from one lateral oral commissure to the other lateral oral commissure whilst in the stretched position

  2 month

Secondary Outcomes (1)

• Vancouver Scar Scale (VSS)

  2 months

Study Arms (1)

The participant was advised to wear the appliance throughout the day .

EXPERIMENTAL

The participant was advised to wear the appliance throughout the day

Other: patient's tailored mouthpiece fitting

Interventions

patient's tailored mouthpiece fitting OTHER

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.

The participant was advised to wear the appliance throughout the day .

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• who underwent skin grafting after suffering from deep second- or third degree burns around the mouth
• who complained of difficulties in daily life such as difficulty in eating, pronunciation, and oral hygine care due to microstomia

You may not qualify if:

• diagnosed with limited temporomandibular joint movement after or before burn injury
• at risk of skin damage when wearing an open mouthpiece
• with bleeding at the scar site or scar at risk of epidermal damage
• with peripheral vascular diseases with reduced blood circulation
• who withdrew consent.

Sponsors & Collaborators

• Hangang Sacred Heart Hospital: lead

Study Sites (1)

Hangang Scared Heart Hospital IRB

Seoul, 07247, South Korea

Location

Related Publications (3)

• Singounas EG. Posttraumatic brainstem damage. Surg Neurol. 1986 Sep;26(3):311. doi: 10.1016/0090-3019(86)90171-0. No abstract available.

  PMID: 3738730 RESULT

• Joo SY, Lee SY, Cho YS, Yi S, Seo CH. Clinical Utility of an Exoskeleton Robot Using Three-Dimensional Scanner Modeling in Burn Patient: A Case Report. J Burn Care Res. 2021 Sep 30;42(5):1030-1034. doi: 10.1093/jbcr/irab060.

  PMID: 33881533 RESULT

• Ki SH, Jo GY, Yoon J, Choi MSS. Reconstruction of microstomia considering their functional status. Arch Craniofac Surg. 2020 Jun;21(3):161-165. doi: 10.7181/acfs.2020.00220. Epub 2020 Jun 29.

  PMID: 32630987 RESULT

MeSH Terms

Conditions

Burns; Microstomia

Condition Hierarchy (Ancestors)

Wounds and Injuries; Mouth Abnormalities; Mouth Diseases; Stomatognathic Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hangang Sacred Heart Hospital

Model Details: Manufacturing patient-tailored mouthpiece using 3D modeling technology. The participant was advised to wear the appliance throughout the day except during meals.

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 4, 2025
• Study Start: July 5, 2025
• Primary Completion: December 30, 2025
• Study Completion: January 30, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-10

Locations

KR (1)