Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-30 @ 7:50 PM
Study NCT ID:
NCT06554769
Status:
COMPLETED
Last Update Posted:
2024-08-15
First Post:
2024-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficiency of Rigid Versus Non-rigid Indirect Anchorage During Canine Retraction: A Split Mouth Randomized Study
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']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'split mouth randomized clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-06-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-14', 'studyFirstSubmitDate': '2024-02-07', 'studyFirstSubmitQcDate': '2024-08-14', 'lastUpdatePostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'anchorage loss', 'timeFrame': '4 month', 'description': 'amount of anchorage loss of the upper first molar during canine retraction using digital model in mm.'}], 'secondaryOutcomes': [{'measure': 'vertical position of the upper second premolar', 'timeFrame': '4 month', 'description': 'The secondary outcome was to assess the change in the vertical position of the upper second premolar following canine retraction using indirect anchorage using digital models in mm.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Orthodontic Appliance Complication']}, 'descriptionModule': {'briefSummary': 'Indirect anchorage (In-A) has been broadly used for anchorage reinforcement during anterior segment retraction. The study compared between the efficacy of rigid vs non-rigid connections of In-A i during upper canine retraction in dentoalveolar protrusion cases', 'detailedDescription': 'Fifteen female patients with dentoalveolar protrusion were included in this study. A miniscrew was inserted following levelling and alignment between the upper first molar and second premolar of both sides. Randomization was applied before first premolar extraction where one side of the arch received a rigid indirect anchorage connection (Group I) of 0.019 x 0.025-inch stainless steel (St.St) archwire from the miniscrew to the auxiliary tube of the upper first molar band, and the other side received a non-rigid indirect anchorage connection (Group II) of 0.014-inch St.St ligature ligating the upper second premolar to the miniscrew. Canine retraction was performed on 0.017 x 0.025-inch St.St archwire applying 1.5 N retraction force. The duration of the study was 7 months. Data was collected from digitized models where anchorage loss of the upper first molar relative to the frontal plane and the vertical position of the upper second premolar were measured'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '23 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdult females Bimaxillary protrusion requiring first premolars extractions Full permanent dentition Good oral hygiene\n\nExclusion Criteria:\n\nHistory of previous orthodontic treatment Abnormalities in teeth size and/or shape Vertical, transverse, or anteroposterior skeletal discrepancies Anti-inflammatory medication'}, 'identificationModule': {'nctId': 'NCT06554769', 'briefTitle': 'Efficiency of Rigid Versus Non-rigid Indirect Anchorage During Canine Retraction: A Split Mouth Randomized Study', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Efficiency of Rigid Versus Non-rigid Indirect Anchorage During Canine Retraction: A Split Mouth Randomized Study', 'orgStudyIdInfo': {'id': 'Cairo University (CairoU)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Non-Rigid connection', 'description': 'side received a non-rigid 0.014-inch St.St ligature ligating the upper second premolar to the miniscrew.', 'interventionNames': ['Procedure: non rigid indirect anchorage connection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rigid Connection', 'description': 'rigid wire 19 x 25 inch stst wire was place between upper first molar and the miniscrew placed between the first molar and second premolar', 'interventionNames': ['Procedure: rigid indirect anchorage connection']}], 'interventions': [{'name': 'non rigid indirect anchorage connection', 'type': 'PROCEDURE', 'description': 'a nonrigid connection is placed between the miniscrews and the second premolar to prevent mesial tooth movement.', 'armGroupLabels': ['Non-Rigid connection']}, {'name': 'rigid indirect anchorage connection', 'type': 'PROCEDURE', 'description': 'a rigid connection is placed between the miniscrews and the first molar to prevent mesial tooth movement.', 'armGroupLabels': ['Rigid Connection']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Ahmed El-Timamy', 'investigatorAffiliation': 'Cairo University'}}}}