3D-Printed Mouth Splints for Small Mouth

(3DMS Trial)

Overseen By Study Coordinator

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Cognitive, TMJ disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new 3D-printed mouth splint designed to help individuals with small mouths due to burn injuries open their mouths wider and improve their quality of life. The goal is to determine if these splints can ease daily activities like eating and speaking. Individuals who struggle to open their mouths due to burn-related scarring may be suitable for the trial. Participants must follow a home exercise plan and attend follow-up visits. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance daily life for burn survivors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this 3D-printed mouth splint is safe?

Research has shown that 3D-printed mouth splints are generally safe. Studies indicate that these splints use materials with low levels of monomers, which can be harmful in large amounts. This composition makes them suitable for clinical use. Tests assessing material safety for the body also confirm the safety of these splints. Designed for comfort, they can be worn for extended periods without causing harm. Overall, the materials in 3D-printed splints are well-tolerated and typically do not cause adverse reactions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about 3D-printed mouth splints for small mouths because they offer a customizable and precise fit that traditional splints, typically made from pre-formed materials, can't match. These splints are created using advanced 3D-printing technology, allowing them to be tailored to the unique shape of each patient's mouth, potentially enhancing comfort and effectiveness. This innovative approach could improve oral aperture measurements more rapidly and comfortably compared to standard options, which often involve more generalized and less adaptable solutions.

What evidence suggests that this 3D-printed mouth splint is effective for increasing oral aperture?

Research has shown that 3D-printed mouth splints could help treat small mouth conditions. These splints widen the mouth opening and reduce issues caused by tightness. Studies have found that 3D printing allows precise control over the splint’s thickness and shape, improving fit and function. Previous research suggests these splints are safer than traditional methods due to fewer harmful materials. Although direct data on mouth tightness is limited, the success of this technology in similar dental applications supports its potential effectiveness. Participants in this trial will receive the 3D-printed mouth splint to assess its impact on oral aperture measurements over a 3-month period. ^{1 4 6 7 8}

Who Is on the Research Team?

Christopher Runyan, MD, PhD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Ability to comply with prescribed home exercises and follow-up visits

I am between 2 and 99 years old with a small mouth due to burn injuries.

Exclusion Criteria

Inability of a caretaker to be able to deliver therapy daily

I have a condition affecting my mouth opening.

I cannot do the required exercises due to physical or mental reasons.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the 3D-printed mouth splint at home, with support from occupational therapists, to improve oral aperture over a 3-month period

12 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 3D-Printed Mouth Splints

Trial Overview

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.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06801535

NCT06801535 | Efficacy of 3D-Printed Mouth Splints

The study will investigate the effectiveness of a 3D-printed mouth splint designed to increase dimensions of oral aperture and reduce disability associated with ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12294031/

Three-Dimensionally Printed Splints in Dentistry

3D printing offers efficiency and improved clinical outcomes. CAD enables control over splint thickness and occlusal geometry, enhancing fit and ...

3.

withpower.com

withpower.com/trial/3d-printed-mouth-splints-for-small-mouth-8d715

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

The study will investigate the effectiveness of a 3D-printed mouth splint designed to increase dimensions of oral aperture and reduce disability associated ...

4.

trialsjournal.biomedcentral.com

trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08437-7

3D printed versus milled stabilization splints for the ... - Trials

This clinical trial assesses the non-inferiority of 3D printed occlusal splints compared to milled occlusal splints in a monocentric prospective randomized ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S2666964122000510

Are 3D printed resin surgical splints safe to use in the ...

CADCAM surgical splints have much lower free monomer content compared to the conventionally made splint, and are safe for clinical use.

6.

3d-colour.com

3d-colour.com/wp-content/uploads/2024/08/MSDS-Dental-Splint-Soft.pdf

HARZ Labs Dental Splint Soft Resin

Resin for 3D printing tough dental models on stereolithographic 3D printers. 1.3 Details of the supplier of the safety data sheet. Company Name. HARZ Labs LLC ...

7.

pro3dure.com

pro3dure.com/en/downloads/dental/safety-data-sheets/

Safety Data Sheets

Safety data sheets are available for 3D printing resins, traditional production (THERMEO), and equipment (CL-1, LCR-1).

8.

merz-dental.de

merz-dental.de/en/digital-solutions/3d-printing/3d-printing-liquids/m-print-splint

M-PRINT Splint

M-PRINT Splint is a biocompatible, light-curing resin for occlusal splints, with high precision, high wearing comfort, and can remain in the mouth permanently.