Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT07155018
Status:
COMPLETED
Last Update Posted:
2025-09-04
First Post:
2025-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Micro-Osteoperforations to Accelerate Maxillary Canine Retraction in Class I Malocclusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008311', 'term': 'Malocclusion, Angle Class I'}], 'ancestors': [{'id': 'D008310', 'term': 'Malocclusion'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Only the outcome assessor was blinded to the intervention allocation. Patients and treating clinicians were aware of the intervention side, but the examiner performing digital measurements and statistical analysis did not know which side received MOPs.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This is a single-blinded, split-mouth randomized controlled trial. Each participant received both interventions: on one side of the maxillary arch, micro-osteoperforations (MOPs) were performed distal to the canine, while the contralateral side served as the control with conventional retraction. Outcomes were measured within the same patient, reducing inter-individual variability.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-27', 'studyFirstSubmitDate': '2025-08-27', 'studyFirstSubmitQcDate': '2025-08-27', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Maxillary Canine Retraction', 'timeFrame': 'Baseline, 4, 8, 12, and 16 weeks', 'description': 'Distance of maxillary canine retraction measured on 3D digital dental models using intraoral scanning.'}], 'secondaryOutcomes': [{'measure': 'Pain Level (VAS Score)', 'timeFrame': 'Day 1, Day 3, Day 7 after intervention', 'description': 'atient-reported pain intensity measured using a 10-cm Visual Analog Scale (VAS), with scores ranging from 0 (no pain) to 10 (worst pain imaginable).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malocclusion, Angle Class I']}, 'descriptionModule': {'briefSummary': 'This single-blinded, split-mouth randomized controlled trial investigates whether micro-osteoperforations (MOPs) can accelerate maxillary canine retraction in orthodontic patients requiring bilateral premolar extraction. The study also evaluates postoperative pain levels using the Visual Analog Scale at 1, 3, and 7 days.', 'detailedDescription': 'MOPs are a flapless, minimally invasive surgical technique that stimulates bone remodeling and may reduce orthodontic treatment time. In this trial, one side of each patient receives MOPs while the contralateral side serves as control. Canine retraction is performed using miniscrews, power arms, and NiTi coil springs. Outcomes include the rate of canine movement over 16 weeks and pain assessment using VAS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 16-25 years\n* Patients requiring bilateral extraction of maxillary first premolars as part of orthodontic treatment\n* Angle Class I molar relationship\n* No previous orthodontic treatment\n\nExclusion Criteria:\n\n* History of craniofacial trauma or congenital anomalies\n* Systemic or bone-related diseases\n* Current smoking\n* Use of medications affecting bone metabolism'}, 'identificationModule': {'nctId': 'NCT07155018', 'acronym': 'MOPs', 'briefTitle': 'Micro-Osteoperforations to Accelerate Maxillary Canine Retraction in Class I Malocclusion', 'organization': {'class': 'OTHER', 'fullName': 'Can Tho University of Medicine and Pharmacy'}, 'officialTitle': 'Effectiveness of Micro-Osteoperforations (MOPs) in Accelerating Maxillary Canine Retraction in Angle Class I Malocclusion: A Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'DuongThaoTrangCtump'}, 'secondaryIdInfos': [{'id': 'IRB-164-', 'type': 'REGISTRY', 'domain': 'Ethics Committee of Can Tho University of Medicine and Pharmacy'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Micro-osteoperforations', 'description': 'On the experimental side, micro-osteoperforations (MOPs) were performed distal to the maxillary canine under local anesthesia using the Excellerator RT device. Three perforations, each 1.5 mm in diameter and 5 mm deep, were created in the attached gingiva. Canine retraction was then carried out using miniscrew anchorage and NiTi closed-coil springs.', 'interventionNames': ['Procedure: Micro-osteoperforations (MOPs)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control: Conventional Retraction', 'description': 'On the control side, maxillary canine retraction was performed using miniscrew anchorage and NiTi closed-coil springs without any micro-osteoperforations. The mechanics were identical to the experimental side to ensure comparability.', 'interventionNames': ['Procedure: Conventional Canine Retraction']}], 'interventions': [{'name': 'Micro-osteoperforations (MOPs)', 'type': 'PROCEDURE', 'description': 'Maxillary canine retraction with miniscrew anchorage and NiTi closed-coil springs, without micro-osteoperforations.', 'armGroupLabels': ['Experimental: Micro-osteoperforations']}, {'name': 'Conventional Canine Retraction', 'type': 'PROCEDURE', 'description': 'Maxillary canine retraction with miniscrew anchorage and NiTi closed-coil springs, without micro-osteoperforations', 'armGroupLabels': ['Control: Conventional Retraction']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Can Tho', 'country': 'Vietnam', 'facility': 'Can Tho University Hospital', 'geoPoint': {'lat': 10.03711, 'lon': 105.78825}}], 'overallOfficials': [{'name': 'Lam Nguyen Le, Ph.D.DDS', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Pediatrics Dentistry and Orthodontics, Faculty of Odonto- Stomatology, Can Tho University of Medicine and Pharmacy, Can Tho City, Vietnam'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared because the study has a small sample size and the data may compromise patient confidentiality.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Can Tho University of Medicine and Pharmacy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}