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Behavioural Intervention

3D-Printed Mouth Splints for Small Mouth (3DMS Trial)

Winston-Salem, NC
N/A
Waitlist Available
Led By Christopher Runyan, MD, PhD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients 2 years to 99 years of age with documented microstomia following burn injuries
Must not have
Cognitive or physical inability to perform the prescribed exercises
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to month 3
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a 3D-printed mouth splint to help people with mouth contractures. They will use a survey to track how well the splint improves patients' ability to eat,

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Who is the study for?
This trial is for individuals with a small mouth opening, often due to scarring or contractures, who have undergone bone marrow transplants. Specific eligibility details are not provided but typically include certain health and demographic criteria.Check my eligibility
What is being tested?
The study tests the effectiveness of a custom-made 3D-printed splint designed to widen the oral aperture. Progress will be measured using the MIDA survey, assessing functionality and quality of life improvements.See study design
What are the potential side effects?
Potential side effects are not detailed in the provided information but may include discomfort, increased salivation, speech difficulties, or irritation from wearing the mouth splint.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 2 and 99 years old with a small mouth due to burn injuries.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot do the required exercises due to physical or mental reasons.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to month 3
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to month 3 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Oral Aperture measurements
Secondary study objectives
Change in Mouth Impairment and Disability Assessment (MIDA) Scores
Change in Patient Satisfaction Scores

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Assess the impact of the 3D-printed mouth splint on oral aperture measurements over a 3-month period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Splint
2005
Completed Phase 2
~150

Find a Location

Closest Location:Wake Forest University Health Sciences· Winston-Salem, NC· 307 miles

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,419 Previous Clinical Trials
2,501,096 Total Patients Enrolled
Christopher Runyan, MD, PhDPrincipal InvestigatorWake Forest University Health Sciences
~7 spots leftby Dec 2025
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