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Efficacy of 3D-Printed Mouth Splints

NCT ID: NCT06801535

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-21

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Microstomia, or reduced oral aperture, is a debilitating condition that can arise after burn injuries, particularly to the face. This condition severely impacts oral hygiene, nutrition, speech, and overall quality of life. Current management strategies often rely on therapy, surgical intervention, and splinting to improve mouth opening and functionality. However, there is a lack of accessibility to good mouth splinting devices. 3D-printed, dynamic splints offer may offer a superior and cost-effective solution that can be tailored to the patient's anatomy while allowing for at-home treatment. Sizing can also be adjusted to fit essentially any aperture since, including pediatrics. This device is intended for use at home, supported by teaching and follow-up provided by occupational therapists (OTs).

Conditions

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Microstomia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Assess the impact of the 3D-printed mouth splint on oral aperture measurements over a 3-month period.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Assess the impact of the 3D-printed mouth splint on oral aperture measurements over a 3-month period.

Group Type EXPERIMENTAL

Splint

Intervention Type DEVICE

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

Interventions

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Splint

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients 2 years to 99 years of age with documented microstomia following burn injuries.
* Ability to comply with prescribed home exercises and follow-up visits.

Exclusion Criteria

* Cognitive or physical inability to perform the prescribed exercises.
* Inability of a caretaker to be able to deliver therapy daily.
* Concomitant conditions that may significantly affect oral aperture (e.g., temporomandibular joint (TMJ) disorders).
Minimum Eligible Age

2 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christopher Runyan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Study Coordinator

Role: CONTACT

[email protected]
3367164171

Facility Contacts

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Caleb Suggs, CCRP

Role: primary

[email protected]
336-713-4339

References

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Couture MA, Calva V, de Oliveira A, LaSalle L, Forget N, Nedelec B. Development and clinimetric evaluation of the mouth impairment and disability assessment (MIDA). Burns. 2018 Jun;44(4):980-994. doi: 10.1016/j.burns.2017.10.024. Epub 2018 Feb 7.

Reference Type RESULT
PMID: 29428487 (View on PubMed)

Related Links

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https://www.thingiverse.com/thing:6162667

Design published for public use:

Other Identifiers

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IRB00124137

Identifier Type: -

Identifier Source: org_study_id