Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2025-12-25 @ 3:06 PM
Study NCT ID:
NCT07169968
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-12
First Post:
2025-08-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Micro-osteoperforations on Lower Anterior Crowding Using Clear Aligners
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-11-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-05', 'studyFirstSubmitDate': '2025-08-21', 'studyFirstSubmitQcDate': '2025-09-05', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'aligner effectivness', 'timeFrame': '3-9 months', 'description': 'Number of aligners prescribed versus required (total number of aligners including refinements) for each group'}], 'secondaryOutcomes': [{'measure': 'relief of dental crowding', 'timeFrame': '3-9 months', 'description': "relief of crowding will be assessed using Little's Irregularity Index"}, {'measure': 'gingival assessment', 'timeFrame': '3-9 months', 'description': 'measuring gingival index before and after treatment'}, {'measure': 'pain assessment', 'timeFrame': 'from day 1 to day 7 after micro-osteoperforations', 'description': 'evaluating pain experienced after micro-osteoperforation using Visula Analoge score (VAS)'}, {'measure': 'periodontal assessment', 'timeFrame': '3-9 months', 'description': 'measuring periodontal pocket depth before and after teatment'}, {'measure': 'tooth mobility assessment', 'timeFrame': '3-9 months', 'description': 'measuring mobility index before and after treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Micro-osteoperforations', 'aligner tracking', 'lower anterior crowding', 'clear aligners'], 'conditions': ['Mandibular Dental Crowding']}, 'descriptionModule': {'briefSummary': 'this randomized controlled trial is designed to compare between clear aligner therapy in alleviating mandibular anterior crowding alone versus with micro-osteoperforations', 'detailedDescription': 'This study is carried on in order to provide a method to enhance the predictability of clear aligner treatment. Loss of aligner tracking is one of the problems encountered during aligner treatment that results in increasing number of aligners required to complete treatment in addition to increasing the overall treatment time and cost. Micro-osteoperforation is a method for acceleration of orthodontic tooth movement and could be used to improve tooth movement and predictability of treatment with clear aligners. So this study is aimed to evaluate the efficiency of aligner treatment during alleviation of lower anterior crowding with and without micro-osteoperforations'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria\n\n1. Adult patients with age ranging from 18 to 35 years.\n2. Healthy periodontium.\n3. Presence of full set of permanent dentition excluding third molars.\n4. Patients requiring non-extraction orthodontic treatment in the mandibular arch.\n5. Mandibular anterior little's irregularity index from 3 to 6.\n6. No spaces in the mandibular arch.\n\nExclusion Criteria:\n\n1. Presence of retained primary teeth in the mandibular arch.\n2. Patients having systemic diseases as (e.g., diabetes, osteoporosis) or taking medication that could affect tooth movement (e.g., bisphosphonates, anticancer drugs)\n3. Vulnerable patients.\n4. Smokers.\n5. Pregnant female patients."}, 'identificationModule': {'nctId': 'NCT07169968', 'briefTitle': 'Effects of Micro-osteoperforations on Lower Anterior Crowding Using Clear Aligners', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Evaluation of the Effects of Micro-Osteoperforations on The Efficiency of Orthodontic Clear Aligner Therapy for Alleviating Mandibular Anterior Crowding: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'FDASU-Rec ID052429'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group 1: Clear aligner treatment', 'description': 'the control group that will receive clear aligner treatment for lower anterior treatment without micro-osteoperforations', 'interventionNames': ['Device: clear aligners group']}, {'type': 'EXPERIMENTAL', 'label': 'group 2: clear aligner treatment with micro-osteoperforations', 'description': "the experimental group that will receive clear aligner treatment for lower anterior treatment with micro-osteoperforations using mini-implants for acceleration of tooth movement and improving aligner's tracking", 'interventionNames': ['Device: micro-osteoperforations group']}], 'interventions': [{'name': 'clear aligners group', 'type': 'DEVICE', 'otherNames': ['control group', 'group 1'], 'description': 'patients with lower anterior crowding, after randomization and allocation, will receive intraoral scanning to create a digital model. using computer software, teeth segmentation, setup and stagging of tooth movement will be carried out. models for each stage of tooth movement will be three-dimentionally printed and the aligners will be thermoformed over each model. patients are instructed to wear each aligner for a week then continue to the next aligner till treatment is finished', 'armGroupLabels': ['group 1: Clear aligner treatment']}, {'name': 'micro-osteoperforations group', 'type': 'DEVICE', 'otherNames': ['experimental group', 'group 2'], 'description': 'patients having lower anteriro crowding, after randomization and allocation, aligners will be produced for them. patients in this group will receive micro-osteoperforation using mini-implants before wearing the first aligner and after one month from starting treatment.', 'armGroupLabels': ['group 2: clear aligner treatment with micro-osteoperforations']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11566', 'city': 'Cairo', 'state': 'Abassia', 'country': 'Egypt', 'facility': 'Department of orthodontics, Faculty of Dentistry, Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}