Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-01-01 @ 6:06 AM
Study NCT ID:
NCT06801535
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of 3D-Printed Mouth Splints
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008865', 'term': 'Microstomia'}, {'id': 'D002971', 'term': 'Cleft Lip'}, {'id': 'C535483', 'term': 'Freeman-Sheldon syndrome'}], 'ancestors': [{'id': 'D009056', 'term': 'Mouth Abnormalities'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008047', 'term': 'Lip Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013165', 'term': 'Splints'}], 'ancestors': [{'id': 'D016267', 'term': 'External Fixators'}, {'id': 'D009984', 'term': 'Orthopedic Fixation Devices'}, {'id': 'D009983', 'term': 'Orthopedic Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D053831', 'term': 'Surgical Fixation Devices'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Assess the impact of the 3D-printed mouth splint on oral aperture measurements over a 3-month period.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2025-01-24', 'studyFirstSubmitQcDate': '2025-01-24', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Oral Aperture measurements', 'timeFrame': 'Baseline to Month 3', 'description': 'Difference in measurements of oral aperture from Baseline visit to Final visit will be reported - Oral aperture measurements taken with calipers'}], 'secondaryOutcomes': [{'measure': 'Change in Mouth Impairment and Disability Assessment (MIDA) Scores', 'timeFrame': 'Baseline to Month 3', 'description': '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.'}, {'measure': 'Change in Patient Satisfaction Scores', 'timeFrame': 'Baseline to Month 3', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['cleft lip and palate', 'craniocarpotarsal dysplasia', 'dental hygiene'], 'conditions': ['Microstomia']}, 'referencesModule': {'references': [{'pmid': '29428487', 'type': 'RESULT', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://www.thingiverse.com/thing:6162667', 'label': 'Design published for public use:'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 2 years to 99 years of age with documented microstomia following burn injuries.\n* Ability to comply with prescribed home exercises and follow-up visits.\n\nExclusion Criteria:\n\n* Cognitive or physical inability to perform the prescribed exercises.\n* Inability of a caretaker to be able to deliver therapy daily.\n* Concomitant conditions that may significantly affect oral aperture (e.g., temporomandibular joint (TMJ) disorders).'}, 'identificationModule': {'nctId': 'NCT06801535', 'acronym': '3DMS', 'briefTitle': 'Efficacy of 3D-Printed Mouth Splints', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Efficacy of 3D-Printed Mouth Splints in the Management of Microstomia in Burn Patients', 'orgStudyIdInfo': {'id': 'IRB00124137'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Assess the impact of the 3D-printed mouth splint on oral aperture measurements over a 3-month period.', 'interventionNames': ['Device: Splint']}], 'interventions': [{'name': 'Splint', 'type': 'DEVICE', 'description': 'Patients will use the splint at home 3 times daily for 10 minutes per session for 3 months total.', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Caleb Suggs, CCRP', 'role': 'CONTACT', 'email': 'csuggs@wakehealth.edu', 'phone': '336-713-4339'}, {'name': 'Christopher Runyan, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Wake Forest University Health Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'centralContacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'email': 'csuggs@wakehealth.edu', 'phone': '3367164171'}], 'overallOfficials': [{'name': 'Christopher Runyan, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}