Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 4:58 AM
Study NCT ID:
NCT07431333
Status:
COMPLETED
Last Update Posted:
2026-02-24
First Post:
2025-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Shape Memory Orthodontic Aligners
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-23', 'studyFirstSubmitDate': '2025-04-08', 'studyFirstSubmitQcDate': '2026-02-23', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The efficiency of both directly printed and thermoformed aligners', 'timeFrame': 'from 6 to 8 months', 'description': 'the relief of mandibular anterior teeth crowding per duration of treatment measured in millimeters per total months'}], 'secondaryOutcomes': [{'measure': 'compliance', 'timeFrame': 'from 6-8 months', 'description': 'patient compliance will be measured by scoring scale from 1 to 10, 1 represents least compliance - 10 represents highest compliance.\n\nMinimum compliance is 5 and maximum one is 10'}, {'measure': 'color stability', 'timeFrame': 'from 6 to 8 months', 'description': 'color stability will be measured through patient questionnaire ( yes or no)'}, {'measure': 'aligners comfortability', 'timeFrame': 'from 6 to 8 months', 'description': 'aligners comfortability will be evaluated by patient questionnaire through choosing emoji faces'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Directly 3d printed clear aligners', 'clear aligners', 'digital orthodontics', 'lower anterior crowding', 'shape memory', 'shape shifting', '4d technology'], 'conditions': ['Crowding of Anterior Mandibular Teeth']}, 'referencesModule': {'references': [{'pmid': '37656070', 'type': 'BACKGROUND', 'citation': 'Spangler T, Ammoun R, Carrico CK, Bencharit S, Tufekci E. The effect of crowding on the accuracy of 3-dimensional printing. Am J Orthod Dentofacial Orthop. 2023 Dec;164(6):879-888. doi: 10.1016/j.ajodo.2023.08.005. Epub 2023 Sep 1.'}, {'type': 'BACKGROUND', 'citation': 'Elshazly, T. M. et al. Primary evaluation of shape recovery of orthodontic aligners fabricated from shape memory polymer (A typodont study). Dent. J. 9, (2021).'}, {'type': 'BACKGROUND', 'citation': 'Tartaglia, G. M. et al. Direct 3D printing of clear orthodontic aligners: Current state and future possibilities. Materials 14, (2021).'}], 'seeAlsoLinks': [{'url': 'http://itgraphy.com', 'label': 'Related Info'}, {'url': 'http://clearxaligners.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Innovative recent materials are trying to achieve the most of orthodontic movements using the least number of aligner, also trying to reduce the manufacturing steps combined by enhancing the accuracy of each aligner.', 'detailedDescription': "The aim of many recent interdisciplinary research studies is to introduce novel materials that can play an active role in the appliances. These materials are called smart materials or stimuli-responsive materials which have the ability to react suitably with external stimuli, such as thermal, electrical, or magnetic input, producing a predictable repeatable output. Shape memory materials are subcategory of smart materials which have the ability of changing their macroscopic shape upon a proper stimulus. Unlike shape changing materials, shape memory materials have the capacity to maintain a stable temporary shape until they are appropriately activated to recover their original shape.\n\nAdditive manufacturing, also known as 3D printing, dates back to the 1980s and is now reaching a level of maturity where it is now increasingly being used in the fields of both dental and medical modeling. There are multiple applications in oral surgery, prosthodontics, restorative dentistry, orthodontics, implantology and instrument manufacturing. Three-dimensional printing enables the manufacturing of pieces' layer-by-layer instead of common manufacturing methods that rely on machining, molding, and subtractive methods.\n\n-Primary outcomes: Evaluation of the efficiency of both linear and angular tooth movement using directly printed shape memory orthodontic aligners Vs thermoformed shape memory orthodontic aligners (predicted Vs actual tooth movement).\n\n-Secondary outcome: Evaluation of patient's compliance, comfort and color stability via written questionnaire."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Crowding in lower anterior teeth ranging from 4 to 6 mm.\n* Participants whose treatment plan need lower anterior teeth alignment.\n* Presence of permanent teeth except for lower premolar extraction performed for orthodontic purposes.\n* Participants who need orthodontic treatment after relapse in lower anterior teeth take place one-year post retention.\n\nExclusion Criteria:\n\n* Active systemic diseases that affect tooth movement (e.g. osteoporosis, bisphosphonate therapy, etc...).\n* Patients with biting habits (clinching, bruxism, etc…)\n* Patients with bad oral hygiene or high caries index or periodontal inflammation or gingival recession.\n* Presence of active labial caries or class V restorations or enamel hypoplasia in lower anterior teeth.'}, 'identificationModule': {'nctId': 'NCT07431333', 'briefTitle': 'Shape Memory Orthodontic Aligners', 'organization': {'class': 'OTHER', 'fullName': 'British University In Egypt'}, 'officialTitle': 'Evaluation of The Efficiency of Directly Printed Shape Memory Vs Thermoformed Shape Memory Orthodontic Aligners', 'orgStudyIdInfo': {'id': 'BUEASUPHD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Directly Printed Shape Memory Orthodontic Aligners used in lower anterior crowding treatment', 'interventionNames': ['Device: shape memory clear aligners']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Thermoformed Shape Memory Orthodontic Aligners used in lower anterior crowding treatment', 'interventionNames': ['Device: shape memory clear aligners']}], 'interventions': [{'name': 'shape memory clear aligners', 'type': 'DEVICE', 'description': 'the usage of shape memory thermoformed clear aligners and the shape memory directly 3d printed clear aligners helps to achieve more biologic tooth movement for the patients', 'armGroupLabels': ['Directly Printed Shape Memory Orthodontic Aligners used in lower anterior crowding treatment', 'Thermoformed Shape Memory Orthodontic Aligners used in lower anterior crowding treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'British university in egypt', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Islam tarek Hassan, Professor of Orthodontics', 'role': 'STUDY_DIRECTOR', 'affiliation': 'British University In Egypt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'still thinking about it'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'British University In Egypt', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ain Shams University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}