Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-26 @ 4:10 AM
Study NCT ID:
NCT05743127
Status:
RECRUITING
Last Update Posted:
2025-06-06
First Post:
2023-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
3D-Printed Versus Laboratory-Fabricated Hyrax Expanders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-03', 'studyFirstSubmitDate': '2023-01-10', 'studyFirstSubmitQcDate': '2023-02-14', 'lastUpdatePostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dimension of the Anterior Midpalatal Suture Opening', 'timeFrame': '2 weeks', 'description': 'The dimension of the anterior midpalatal suture opening between the maxillary halves will be measured digitally in millimeters on the occlusal radiograph using a calibrated ruler.'}], 'secondaryOutcomes': [{'measure': 'Change in Interincisal Diastema Width', 'timeFrame': '2 weeks', 'description': 'The change in interincisal diastema width will be measured in millimeters on the post-expansion (T1) digital models between the maxillary central incisors using OrthoAnalyzer 3D software.'}, {'measure': 'Change in Maxillary Molar Inclination', 'timeFrame': '2 weeks', 'description': 'Using measurement tools in OrthoAnalyzer 3D software and the T0 digital models, the inter-molar inclination of the maxillary permanent first molars will be evaluated. The inclination of the T1 maxillary permanent first molars will be measured in a like-manner as the T0 digital models. The intermolar inclination measurement at T1 will be subtracted from the intermolar inclination measurement at T0 to record any presumably positive increase in molar inclination.'}, {'measure': 'Change in Maxillary Arch Widths', 'timeFrame': '2 weeks', 'description': 'The measurements of the maxillary dental arch widths will be performed on the pre-expansion (T0) and post-expansion (T1) digital models using the OrthoAnalyzer software. The intercanine, interpremolar or first deciduous molar, and intermolar widths will be measured in millimeters. The widths at T0 will be subtracted from the widths at T1 to record any positive increase in arch widths.'}, {'measure': 'Pain Perception assessed by Visual Analog Scale', 'timeFrame': '2 weeks', 'description': 'Using an online questionnaire, patients will be asked about the highest pain level they will have experienced at different time points using the visual analog scale (VAS). The higher the value in the VAS scale, the more severe the pain.'}, {'measure': 'Pain Perception assessed by Wong-Baker FACES Scale', 'timeFrame': '2 weeks', 'description': 'Using an online questionnaire, patients will be asked about the highest pain level they will have experienced at different time points using the Wong-Baker FACES Scale. The more upset the face in the Wong-Baker FACES Scale, the more severe the pain.'}, {'measure': 'Oral Health Related Quality of Life (functional limitation, physical discomfort, psychological discomfort, physical disability, psychological disability, social disability, and handicap) assessed by OHIP-14', 'timeFrame': '2 weeks', 'description': 'Using an online questionnaire, patients will be asked about his/her quality of life at different time points using the short version of the Oral Health Impact Profile (OHIP-14). The OHIP-14 has 14 questions distributed across seven domains: functional limitation, physical discomfort, psychological discomfort, physical disability, psychological disability, social disability, and handicap. The scores for each domain and the total score will be evaluated. A higher score indicates a more negative perception of the individual with respect his/her quality of life. The lowest score is 0, which indicates a more positive perception of the individual with respect his/her quality of life. The highest score is 4, which indicates a more negative perception of the individual with respect his/her quality of life.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Maxillary Expansion']}, 'descriptionModule': {'briefSummary': "Maxillary expanders are orthodontic appliances that are commonly used to expand the upper jaw. The purpose of this study will be to compare the effects produced by two different maxillary expanders in children 8-13 years old. The first type of expander is made by hand in an orthodontic laboratory, and the second type of expander is designed on a computer and printed using 3D printers. Both expanders are already used in the MUSC Orthodontics Clinic. The purpose of this study is to see if the 3D printed expander is as effective as the traditional expander made by hand in the laboratory, with more comfort to the patient. Patients participating in the study will be randomly assigned to one of two groups: group A will be treated with a laboratory-made maxillary expander, and group B with a 3D-Printed maxillary expander. Information will be collected on the participants' standard clinical follow-up visits including photos, x-rays, and dental photo scans over the course of 6 months to see how the expander is working. In addition, as part of the research study, the participant will be asked to complete online questionnaires with assistance from parents or guardians about his/her quality of life and perception of possible pain and discomfort at different time points. The potential benefits of this study include the use of 3D technology to improve the quality of the orthodontic treatment, with more comfort to the patient."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Maxillary anterior and/or posterior transverse deficiency with or without crossbite\n* Age of 8-13 years\n* Children whose parents/guardians are willing to consent to the child participating in the study\n* Children ages 12-13 who are willing to assent to participating in the study\n* Children who are orthodontic patients at the Medical University of South Carolina Department of Orthodontics or University of Pittsburgh School of Dental Medicine\n* Subjects and parents/guardians who have access to an electronic device with internet connection\n\nExclusion Criteria:\n\n* Patients with previous or ongoing orthodontic treatment\n* Patients whose parents have a strong preference as to which expander is used\n* Patients with a history of temporomandibular disorders\n* Presence of congenitally missing teeth\n* Traumatic loss of maxillary incisors\n* Patients with craniofacial syndromes, or cleft lip and/or palate'}, 'identificationModule': {'nctId': 'NCT05743127', 'briefTitle': '3D-Printed Versus Laboratory-Fabricated Hyrax Expanders', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': '3D-Printed Versus Laboratory-Fabricated Hyrax Expanders: A Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'STUDY24070148'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group Conventional Expander', 'description': 'Conventional Laboratory Fabricated Hyrax Expander', 'interventionNames': ['Device: Conventional Laboratory Fabricated Hyrax Expander']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3-D Printed Expander', 'description': '3D-Printed Hyrax Expander', 'interventionNames': ['Device: 3D-Printed Hyrax Expander']}], 'interventions': [{'name': '3D-Printed Hyrax Expander', 'type': 'DEVICE', 'description': 'This is a type of maxillary expander that is designed on a computer and printed in metal using 3D printers and is used to expand the upper jaw.', 'armGroupLabels': ['Group 3-D Printed Expander']}, {'name': 'Conventional Laboratory Fabricated Hyrax Expander', 'type': 'DEVICE', 'description': 'This is a type of maxillary expander that is made by hand in an orthodontic laboratory and is used to expand the upper jaw.', 'armGroupLabels': ['Group Conventional Expander']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ildeu Andrade, DDS, MS, PhD', 'role': 'CONTACT', 'email': 'ildeu.andrade@pitt.edu', 'phone': '412-648-3369'}], 'facility': 'University of Pittsburgh - School of Dental Medicine', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ildeu Andrade, DDS, MS, PhD', 'role': 'CONTACT', 'email': 'andradei@musc.edu', 'phone': '8437923366'}], 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'centralContacts': [{'name': 'Ildeu Andrade, DDS, MS, PhD', 'role': 'CONTACT', 'email': 'ildeu.andrade@pitt.edu', 'phone': '843-792-3366'}], 'overallOfficials': [{'name': 'Ildeu Andrade, DDS, MS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ildeu Andrade Jr.', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Association of Orthodontics Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Ildeu Andrade Jr.', 'investigatorAffiliation': 'University of Pittsburgh'}}}}