Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-25 @ 9:15 PM
Study NCT ID:
NCT06246656
Status:
RECRUITING
Last Update Posted:
2025-09-05
First Post:
2023-03-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Hard and Soft Tissue Change During Maxillary Expansion Using a Computer-aided Design / Computer-aided Manufacturing Appliance.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010155', 'term': 'Palatal Expansion Technique'}], 'ancestors': [{'id': 'D009971', 'term': 'Orthodontics, Corrective'}, {'id': 'D009970', 'term': 'Orthodontics'}, {'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 38}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-29', 'studyFirstSubmitDate': '2023-03-10', 'studyFirstSubmitQcDate': '2024-02-06', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Millimetric landmark changes of hard and soft tissue measured by the digital superimposition of CBCT Scans.', 'timeFrame': 'up to six months', 'description': 'Comparison of midfacial landmark changes during maxillary expansion'}], 'secondaryOutcomes': [{'measure': 'CAD/CAM milled versus 3D printed guides for orthodontic TADs compared by the millimetric and angular deviation of planned and clinical position.', 'timeFrame': 'up to 4 weeks', 'description': 'Transfer accuracy of milled and 3D printed drilling templates'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CAD/CAM', 'Orthodontics', 'Maxillary Expansion', 'Soft Tissue Change'], 'conditions': ['Palatal Expansion Technique']}, 'descriptionModule': {'briefSummary': '* Hard tissue changes during the transversal expansion of the maxilla using a CAD/CAM expansion appliance.\n* Soft tissue changes during the transversal expansion of the maxilla using a CAD/CAM expansion appliance.\n\nParticipants will undergo orthodontic treatment, including:\n\n* Initial records (intraoral scan, CBCT (cone-beam computed tomography) scan, face scan)\n* Placement of guided orthodontic TADs (Temporary Anchorage Devices)\n* Skeletal expansion using CAD/CAM appliance\n* Fixed multibracket appliance in the upper and lower jaw\n* Intermediate and terminal documents (intraoral scan, CBCT scan, face scan)', 'detailedDescription': 'This clinical trial aims to evaluate the influence of maxillary expansion using a CAD/CAM-manufactured appliance impact on the soft and hard tissues in the midfacial region in adolescent and adult orthodontic patients.\n\nThis study aims to evaluate how this treatment changes the bony structures and soft tissues (for example, the nose) in the mid-facial region during the transversal expansion of the maxilla using a CAD/CAM expansion appliance.\n\nThe appliance consists of two anchorage elements on the first molars and two TADs. The mini-screws are placed on the palate under local anesthesia with the help of drilling templates.\n\nCAD/CAD milled and 3D printed guides will be used for the placement of the TADs.\n\nThe study will be conducted on orthodontic patients between 12 and 26 years who will receive fixed orthodontic braces in the upper and lower jaw and show a width deficit of the upper jaw.\n\nIntraoral, face, and computed tomography (CT) scans will be used for the investigation. An intraoral and face scanner enables a high-resolution 3D image of the teeth and face. A CBCT Scan is a three-dimensional X-ray image.\n\nThese examinations do not involve pain and are performed during regular follow-up appointments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '26 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Maxillary transverse deficit,\n* Lateral crossbite\n\nExclusion Criteria:\n\n* Previous orthodontic treatment,\n* Craniofacial anomalies,\n* Severe facial asymmetries,\n* Pregnancy,\n* Periodontal lesions'}, 'identificationModule': {'nctId': 'NCT06246656', 'briefTitle': 'Evaluation of Hard and Soft Tissue Change During Maxillary Expansion Using a Computer-aided Design / Computer-aided Manufacturing Appliance.', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Hard and Soft Tissue Changes During Maxillary Expansion Using Skeletally Anchored Appliances: a Prospective, Randomized Clinical Study.', 'orgStudyIdInfo': {'id': '1804/2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CAD/CAM milled TAD guides', 'description': 'The position guides for orthodontic Temporary Anchorage Devices (TAD) will be produced by CAD/CAM milling.', 'interventionNames': ['Procedure: Maxillary Expansion']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3D printed guides', 'description': 'The position guides for orthodontic Temporary Anchorage Devices (TAD) will be produced by 3D printing technology.', 'interventionNames': ['Procedure: Maxillary Expansion']}], 'interventions': [{'name': 'Maxillary Expansion', 'type': 'PROCEDURE', 'description': 'Palatal Expansion using a CAD/CAM appliance', 'armGroupLabels': ['3D printed guides', 'CAD/CAM milled TAD guides']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'state': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Alexander Schwärzler DMD Prinzipal Investigator, DMD', 'role': 'CONTACT', 'email': 'alexander.schwaerzler@meduniwien.ac.at', 'phone': '+436649222987'}], 'facility': 'Medical University of Vienna, Department of Orthodontics', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Sophia Panwinkler, DMD', 'role': 'CONTACT', 'email': 'sophia.panwinkler@meduniwien.ac.at', 'phone': '+431400704301'}], 'overallOfficials': [{'name': 'Xiaohui Rausch-Fan, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Center of Clinical Research, University Clinic of Dentistry, Medical University of Vienna'}, {'name': 'Alexander Schwärzler, DMD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Orthodontics, University Clinic of Dentistry, Medical University of Vienna'}, {'name': 'Erwin Jonke, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Orthodontics, University Clinic of Dentistry, Medical University of Vienna'}, {'name': 'Sophia Panwinkler, DMD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Orthodontics, University Clinic of Dentistry, Medical University of Vienna'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Alexander Schwaerzler, DMD', 'investigatorAffiliation': 'Medical University of Vienna'}}}}