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

Trial Summary

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 data supports the effectiveness of 3D-Printed Mouth Splints for treating small mouth conditions?

Research on 3D-printed splints for orthognathic surgery shows that these splints can be accurately produced and are clinically accepted in most cases, suggesting that 3D printing technology is effective for creating customized splints. This indicates that 3D-printed mouth splints could be similarly effective for treating small mouth conditions by providing a precise and personalized fit. ^{1 2 3 4 5}

Is it safe to use 3D-printed mouth splints?

Research on 3D-printed mouth splints shows they are generally safe, with studies focusing on their biocompatibility (how well they work with the body) and effectiveness in preventing issues like postoperative bleeding. However, more research is needed to fully understand their safety across different uses. ^{4 5 6 7 8}

How do 3D-Printed Mouth Splints differ from other treatments for small mouth conditions?

3D-Printed Mouth Splints are unique because they are custom-made using a 3D printer, allowing for precise fitting and rapid production. This method can be more efficient and cost-effective compared to traditional splint manufacturing techniques, and it offers the flexibility of remote, contactless fitting, which is particularly useful in situations where in-person visits are challenging. ^{1 5 9 10 11}

What is the purpose of this trial?

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.

Research Team

Christopher Runyan, MD, PhD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Manufacturing splints for orthognathic surgery using a three-dimensional printer. [2022]

2. Scotland pubmed.ncbi.nlm.nih.gov

Accuracy of patient-specific implants and additive-manufactured surgical splints in orthognathic surgery - A three-dimensional retrospective study. [2019]

3. Scotland pubmed.ncbi.nlm.nih.gov

Optimized 3D virtually planned intermediate splints for bimaxillary orthognathic surgery: A clinical validation study in 20 patients. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Comparison between Additive and Subtractive CAD-CAM Technique to Produce Orthognathic Surgical Splints: A Personalized Approach. [2020]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluation of wear behaviour of various occlusal splint materials and manufacturing processes. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

3D Printing Applications for Craniomaxillofacial Reconstruction: A Sweeping Review. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Fully Digital Workflow for the Fabrication of Three-Dimensionally Printed Surgical Splints for Preventing Postoperative Bleeding: A Case Report. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Cytotoxicity of 3D-printed, milled, and conventional oral splint resins to L929 cells and human gingival fibroblasts. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

[The use of miniature plastic splints in dentistry]. [2006]

10. Denmark pubmed.ncbi.nlm.nih.gov

Efficient in-house 3D printing of an orthognathic splint for single-jaw cases. [2021]

11. Singapore pubmed.ncbi.nlm.nih.gov

Contactless Remote 3D Splinting during COVID-19: Report of Two Patients. [2022]