Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 9:29 PM
Study NCT ID:
NCT07411092
Status:
RECRUITING
Last Update Posted:
2026-02-13
First Post:
2026-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Three-dimensionally Printed Hyrax Versus Conventional Hyrax for Maxillary Arch Expansion in Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-08', 'studyFirstSubmitDate': '2026-01-24', 'studyFirstSubmitQcDate': '2026-02-08', 'lastUpdatePostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amount of mid-palatal suture opening.', 'timeFrame': 'Three weeks', 'description': 'The amount of suture separation measured in millimeters in the axial plane through CBCT X-ray'}], 'secondaryOutcomes': [{'measure': 'Amount of dental expansion', 'timeFrame': 'Three weeks', 'description': 'Dental expansion will be measured as changes in inter-canine width and intermolar width (in millimeters) on digital dental models.'}, {'measure': 'The amount of tipping of maxillary molars and premolars.', 'timeFrame': 'Three weeks', 'description': 'Buccolingual tipping of maxillary molars and premolars will be quantified as angular changes measured on CBCT by comparing pre-expansion and post-expansion images.'}, {'measure': 'Change of buccal alveolar bone thickness.', 'timeFrame': 'Three weeks', 'description': 'Changes in buccal alveolar bone thickness in millimeters will be measured on pre-expansion and post-expansion CBCT scans.'}, {'measure': 'Pain assessment', 'timeFrame': 'Three weeks', 'description': 'Evaluating the pain experienced during the active expansion phase using the Visual Analogue Scale (VAS; 0-100 mm), where 0 mm represents no pain and 100 mm represents the worst imaginable pain; the higher the value in the VAS scale, the more severe the pain.'}, {'measure': 'Oral health-related quality of life.', 'timeFrame': 'Three weeks', 'description': 'Oral health-related quality of life was assessed using the Oral Health Impact Profile-14 (OHIP-14). Items are rated on a 5-point Likert scale (0 = never to 4 = very often). Results are presented as mean scores (0-4); higher values indicate worse oral health-related quality of life.'}, {'measure': 'Stability of transverse skeletal width at 6 months post-expansion', 'timeFrame': 'Six months', 'description': 'The transverse skeletal dimension after appliance removal after six months post-expansion will be measured in the axial plane on the CBCT X-ray.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Maxillary Expansion', 'Hyrax expander'], 'conditions': ['Transverse Maxillary Deficiency', 'Maxillary Expansion']}, 'descriptionModule': {'briefSummary': 'This clinical trial aims to compare the skeletal and dental effects of conventional Hyrax expanders and 3D-printed Hyrax expanders in adolescent patients with maxillary transverse deficiency. Using cone-beam computed tomography (CBCT) and digital models, the study evaluates the precision, customization, and treatment outcomes of both appliance types to inform evidence-based orthodontic treatment planning.', 'detailedDescription': 'Maxillary transverse deficiency is a common orthodontic problem that often requires skeletal expansion using appliances such as the Hyrax expander. While conventional Hyrax expanders have been widely used, advancements in digital dentistry have introduced 3D-printed alternatives that offer potential benefits in precision, customization, and patient comfort. However, there is currently no clinical evidence comparing the skeletal and dental effects of these two designs.\n\nThis study addresses this gap by evaluating and comparing the outcomes of conventional and 3D-printed Hyrax expanders in adolescent patients, a critical developmental stage where maxillary expansion becomes more challenging due to progressive maturation and increased resistance of the mid-palatal suture. The study uses cone-beam computed tomography (CBCT) and digital models to assess skeletal and dental changes, providing clinically relevant data to guide orthodontic treatment planning and appliance selection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients aged between 12 to 17 years.\n2. Skeletal age ranges from CVMS 3 to CVMS 5.\n3. Skeletal maxillary transverse deficiency with/without crossbite.\n4. Cooperative and able to attend follow-up visits.\n\nExclusion Criteria:\n\n1. Previous orthodontic treatment.\n2. Craniofacial syndromes, or cleft lip and/or palate.\n3. Patients with vertical growth pattern.\n4. Very bad oral hygiene and active periodontal disease.\n5. Vulnerable groups such as individuals with cognitive impairments or intellectual disabilities and individuals with severe mental health disorders.'}, 'identificationModule': {'nctId': 'NCT07411092', 'briefTitle': 'Three-dimensionally Printed Hyrax Versus Conventional Hyrax for Maxillary Arch Expansion in Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Three-dimensionally Printed Hyrax Versus Conventional Hyrax for Maxillary Arch Expansion in Adolescents: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'FDASU-Rec IR/D072507'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A: 3D-Printed Hyrax Expander', 'description': 'Adolescent patients diagnosed with transverse maxillary arch constriction will undergo maxillary expansion using a three-dimensionally printed Hyrax expander.', 'interventionNames': ['Device: Three dimensionally printed hyrax expander']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B: Conventionally Fabricated Hyrax Expander', 'description': 'Adolescent patients diagnosed with transverse maxillary arch constriction will undergo maxillary expansion using using a conventionally fabricated Hyrax expander.', 'interventionNames': ['Device: Conventionally Fabricated Hyrax Expander']}], 'interventions': [{'name': 'Three dimensionally printed hyrax expander', 'type': 'DEVICE', 'description': 'Group A : A 3D-printed Hyrax expander designed for rapid maxillary expansion in orthodontic treatment. The device is manufactured using additive manufacturing technology for a customized fit.', 'armGroupLabels': ['Group A: 3D-Printed Hyrax Expander']}, {'name': 'Conventionally Fabricated Hyrax Expander', 'type': 'DEVICE', 'description': 'Group B: A conventionally fabricated Hyrax expander used for rapid maxillary expansion . The device is made using traditional laboratory techniques.', 'armGroupLabels': ['Group B: Conventionally Fabricated Hyrax Expander']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11566', 'city': 'Cairo', 'state': 'Cairo Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Sara Sherif Saleh Sherif Assistant lecturer, A', 'role': 'CONTACT', 'email': 'sarasaleh@dent.asu.edu.eg', 'phone': '+20 1061531431'}], 'facility': 'Faculty of dentistry, Ain Shams univeristy', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Sara S Mandour, Msc, Assistant lecturer', 'role': 'CONTACT', 'email': 'sarasaleh@dent.asu.edu.eg', 'phone': '+201061531431'}, {'name': 'Marwah S Abdel-Latif, Msc, PHD, Lecturer', 'role': 'CONTACT', 'email': 'marwahsalah@asfd.asu.edu.eg', 'phone': '+201002955774'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}