Microstomia3DMSNCT06801535
Efficacy of 3D-Printed Mouth Splints
A study testing Splint in people with Microstomia, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 99 years
- Conditions the study is for
- Microstomia
- What is being tested?
- Splint
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Caleb Suggs, CCRP, 336-713-4339, csuggs@wakehealth.edu
Christopher Runyan, MD, PhD
About this study
Official title: Efficacy of 3D-Printed Mouth Splints in the Management of Microstomia in Burn Patients
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.
Read the detailed description
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
- Microstomia
- Being tested
- Splint
- Keywords
- cleft lip and palate, craniocarpotarsal dysplasia, dental hygiene
- Medical subject headings
- Microstomia, Cleft Lip, Freeman-Sheldon syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SplintDevice
Patients will use the splint at home 3 times daily for 10 minutes per session for 3 months total.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Assess the impact of the 3D-printed mouth splint on oral aperture measurements over a 3-month period. Receives: Device: Splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oral Aperture measurements
Difference in measurements of oral aperture from Baseline visit to Final visit will be reported - Oral aperture measurements taken with calipers
Measured: Baseline to Month 3
Secondary outcomes (2)
Change in Mouth Impairment and Disability Assessment (MIDA) Scores
The mouth impairment and disability assessment (MIDA) has a 28 item self-report portion, divided into four subscales, completed by the patient and an impairment-based section completed by the burn therapist. The Mouth Impairment and Disability Assessment (MIDA) scale typically ranges from a low score indicating minimal impairment to a high score representing significant disability, with the exact range depending on the specific version of the scale and how individual items are scored; however, most versions will have a total score that can be interpreted within a broader range of severity, with higher scores signifying greater impairment. This assessment is scored from 0 to 64. Zero is equivalent to no difficulty and 64 would indicate the highest level of difficulty.
Measured: Baseline to Month 3
Change in Patient Satisfaction Scores
Total patient satisfaction scored on survey at weekly visits to be reported from 0 to 23. 0 equivalent to no satisfaction and 23 is the highest level of satisfaction.
Measured: Baseline to Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start21 Feb 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MicrostomiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Assess the impact of the 3D-printed mouth splint on oral aperture measurements over a 3-month period.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Runyan, MD, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801535
- Sponsor's protocol ID
- IRB00124137
- Acronym
- 3DMS
- Status last verified
- Dec 2025
- First submitted
- 24 Jan 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 29428487
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of 3D-Printed Mouth Splints in the Management of Microstomia in Burn Patients
- ClinicalTrials.gov ID
- NCT06801535
- Acronym / sponsor ID
- 3DMS / IRB00124137
- Conditions
- Microstomia
- Keywords
- cleft lip and palate, craniocarpotarsal dysplasia, dental hygiene
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 21 Feb 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Assess the impact of the 3D-printed mouth splint on oral aperture measurements over a 3-month period.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: SplintAssess the impact of the 3D-printed mouth splint on oral aperture measurements over a 3-month period. |
Who may qualify
- Ages
- 2 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SplintPatients will use the splint at home 3 times daily for 10 minutes per session for 3 months total. | Device | Treatment |
Primary outcome
Change in Oral Aperture measurements
Time frame: Baseline to Month 3
Difference in measurements of oral aperture from Baseline visit to Final visit will be reported - Oral aperture measurements taken with calipers
2 secondary outcomes
Change in Mouth Impairment and Disability Assessment (MIDA) Scores
Time frame: Baseline to Month 3
Change in Patient Satisfaction Scores
Time frame: Baseline to Month 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Results publication: PubMed 29428487Couture 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.
- Design published for public use:Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Systemic Scleroderma
Enrolling by invitation
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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher Runyan, MD, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Splint in people with Microstomia, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Coordinator (3367164171, csuggs@wakehealth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Oral Aperture measurements (time frame: Baseline to Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06801535, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.