Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:27 PM
Study NCT ID:
NCT07191158
Status:
RECRUITING
Last Update Posted:
2025-09-24
First Post:
2025-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Three-Dimensional Printed Orthodontic Molar Distalizer
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'], 'maskingDescription': "The study will be a single blinded because both the patients and the investigator will be aware of the allocation during treatment, but the cephalograms and digital models will be scored and coded by an independent person, i.e. pre-and post-treatment cephalograms and digital models will be analyzed after replacing the patients' names with codes, and the examiner conducting the measurement analysis will be unaware of the group to which the patient has been allocated."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-22', 'studyFirstSubmitDate': '2025-08-29', 'studyFirstSubmitQcDate': '2025-09-22', 'lastUpdatePostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of molar Distalization', 'timeFrame': '6 months', 'description': '• The efficiency of molar distalization in terms of the amount of molar distalization, degree of distal tipping and bodily translation movements by using a lateral cephalogram linear and angular measurements.'}], 'secondaryOutcomes': [{'measure': 'Patient discomfort', 'timeFrame': '10 days', 'description': "• Patient's pain and discomfort using visual analogue scale (VAS). The minimum score is zero and the maximum score is 10."}, {'measure': 'Molar distalization', 'timeFrame': '6 months', 'description': 'The efficiency of molar distalization in terms of the amount of molar distalization, degree of distal tipping and bodily translation movements by using a lateral cephalogram linear and angular measurements. - The efficiency of molar distalization in terms of the amount of molar distalization, - degree of distal tipping and bodily translation movements by using a lateral cephalogram linear and angular measurements'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Distalization', 'tooth movement', '3D printing'], 'conditions': ['Tooth Movement Techniques', 'Distalization by Miniscrews']}, 'referencesModule': {'references': [{'pmid': '31516664', 'type': 'BACKGROUND', 'citation': 'Cassetta M, Brandetti G, Altieri F. Miniscrew-supported distal jet versus conventional distal jet appliance: A pilot study. J Clin Exp Dent. 2019 Jul 1;11(7):e650-e658. doi: 10.4317/jced.55780. eCollection 2019 Jul.'}]}, 'descriptionModule': {'briefSummary': 'A randomized clinical trial to evaluate a newly designed 3D printed miniscrew-supported molar distalization device in comparison to the conventional miniscrew-supported distal jet appliance in correction of Class II malocclusion and upper arch crowding.', 'detailedDescription': "It is a multicenter randomized clinical trial with two parallel arms. The patients will be randomly divided into two groups, group one: conventional miniscrew-supported distal jet appliance will be used while for group two, new 3D printed miniscrew-supported molar distalizers is going to be utilized. Lateral cephalometric x-ray and digital models of upper arch will be taken before starting the treatment (T0) and at the end of molar distalization (T1). The effectiveness of the two appliances will be assessed and measured comparing patient's records before and after treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Class II molar relationships bilaterally, with fully erupted 2nd molar.\n2. No or minor crowding on the mandible to \\[reserve Class I posterior occlusion after treatment.\n3. Good oral health free from caries and periodontal problems at the start of treatment.\n\n \\-\n\nExclusion Criteria:\n\n1. Previous history of orthopedic and/or orthodontic treatment.\n2. Patients with cleft lip and palate and/or craniofacial syndrome\n3. Patients with bad oral habit.\n4. Active periodontal disease.\n5. Sever rotation of maxillary molars. -'}, 'identificationModule': {'nctId': 'NCT07191158', 'acronym': 'RCT', 'briefTitle': 'Evaluation of Three-Dimensional Printed Orthodontic Molar Distalizer', 'organization': {'class': 'OTHER', 'fullName': 'University of Baghdad'}, 'officialTitle': 'Evaluation of Three-Dimensional Printed Orthodontic Molar Distalizer (Randomized Clinical Trial)', 'orgStudyIdInfo': {'id': '1020425'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1 distalization', 'description': 'Conventional miniscrew-supported distal jet appliance', 'interventionNames': ['Device: Group 1 conventional']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 (interventional)', 'description': 'New 3D printed miniscrew-supported molar distalizers', 'interventionNames': ['Device: Group 2 3D printed']}], 'interventions': [{'name': 'Group 1 conventional', 'type': 'DEVICE', 'description': 'Conventional miniscrew-supported distal jet appliance', 'armGroupLabels': ['Group 1 distalization']}, {'name': 'Group 2 3D printed', 'type': 'DEVICE', 'description': 'New 3D printed miniscrew-supported molar distalizers', 'armGroupLabels': ['Group 2 (interventional)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01110', 'city': 'Baghdad', 'state': 'Al-Russafa', 'status': 'RECRUITING', 'country': 'Iraq', 'contacts': [{'name': 'Salwan Pede Professor, PhD', 'role': 'CONTACT', 'email': 'ethical.approval@codental.uobaghdad.edu.iq', 'phone': '+964 1 4169375'}], 'facility': 'College of Dentistry-University of Baghdad', 'geoPoint': {'lat': 33.34058, 'lon': 44.40088}}], 'centralContacts': [{'name': 'Mushriq Abid Fawzi Professor, PhD', 'role': 'CONTACT', 'email': 'mushriq.abid@codental.uobaghdad.edu.iq', 'phone': '009647718800706'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Baghdad', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Mushriq F. Abid', 'investigatorAffiliation': 'University of Baghdad'}}}}