RECRUITING

Efficacy of 3D-Printed Mouth Splints

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Efficacy of 3D-Printed Mouth Splints in the Management of Microstomia in Burn Patients

Quick Facts

Study Start:2025-02-21
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06801535

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients 2 years to 99 years of age with documented microstomia following burn injuries.
  2. * Ability to comply with prescribed home exercises and follow-up visits.
  1. * Cognitive or physical inability to perform the prescribed exercises.
  2. * Inability of a caretaker to be able to deliver therapy daily.
  3. * Concomitant conditions that may significantly affect oral aperture (e.g., temporomandibular joint (TMJ) disorders).

Contacts and Locations

Study Contact

Study Coordinator
CONTACT
3367164171
csuggs@wakehealth.edu

Principal Investigator

Christopher Runyan, MD, PhD
PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences

Study Locations (Sites)

Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

  • Christopher Runyan, MD, PhD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-21
Study Completion Date2025-12

Study Record Updates

Study Start Date2025-02-21
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • cleft lip and palate
  • craniocarpotarsal dysplasia
  • dental hygiene

Additional Relevant MeSH Terms

  • Microstomia