Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-03-01 @ 10:10 AM
Study NCT ID:
NCT05626335
Status:
COMPLETED
Last Update Posted:
2022-11-23
First Post:
2022-11-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Double With Regular Monitoring Prevent Undesired Tooth Movement?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008310', 'term': 'Malocclusion'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-09-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-15', 'studyFirstSubmitDate': '2022-11-15', 'studyFirstSubmitQcDate': '2022-11-15', 'lastUpdatePostDateStruct': {'date': '2022-11-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tooth displacement in mm', 'timeFrame': 'One month after debonding', 'description': 'Measurement obtained by comparing superimposed scans'}, {'measure': 'Tooth displacement in mm', 'timeFrame': 'Three months after debonding', 'description': 'Measurement obtained by comparing superimposed scans'}, {'measure': 'Tooth displacement in mm', 'timeFrame': 'Six months after debonding', 'description': 'Measurement obtained by comparing superimposed scans'}], 'secondaryOutcomes': [{'measure': 'Failure rate', 'timeFrame': 'Six months of observation', 'description': 'Registration wherever the retention failure occured'}, {'measure': 'Compliance rate', 'timeFrame': 'Six months of observation', 'description': 'Registration of patients attending to scheduled visits'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['retention', 'stability', 'orthodontic treatment', '3D analysis', 'intraoral scan'], 'conditions': ['Malocclusion']}, 'descriptionModule': {'briefSummary': 'The goal of observational study is to learn about the stability of orthodontic treatment results in orthodontic patients during retention phase of treatment.', 'detailedDescription': 'The aim of the present study was to three-dimensionally analyze tooth movement in retention phase of treatment and wherever double effectively retention prevents it.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study group comprised 300 patients adult patients (age 18 to 41) who have completed fixed orthodontic treatment between (1st January 2021 - 9th September 2022).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-extraction treatment\n* No hypodontia\n* Normal occlusion after treatment (Class I occlusion), perfect alignment\n* Normal overjet and overbite\n* Double retention including fixed retainer bonded from canine to canine in both dental arches and thermally formed removable splint\n\nExclusion Criteria:\n\n* Fixed orthodontic treatment in one dental arch\n* Extraction cases\n* Patient treated with orthognathic surgery\n* Imperfect treatment result due to treatment cessation on patients demand or health issues\n* Craniofacial disorders'}, 'identificationModule': {'nctId': 'NCT05626335', 'briefTitle': 'Does Double With Regular Monitoring Prevent Undesired Tooth Movement?', 'organization': {'class': 'OTHER', 'fullName': 'Pomeranian Medical University Szczecin'}, 'officialTitle': 'Does Double (Fixed and Removable Orthodontic Retention) With Regular Monitoring Prevent Undesired Tooth Movement?', 'orgStudyIdInfo': {'id': 'KB-0012/74/10/2020/Z'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'From all the patients meeting the inclusion criteria every third patients was randomly chosen and invited to participate in the study. Written informed consent was obtained from every participant. Thus 100 patients have agreed to participate. All fixed retainers (stainless steel braided rectangular wire) were bonded in both arches by the same experienced clinician, who subsequently made impression for thermally formed splints and delivered them on the day of debonding. The effect of each of the procedures was verified by two independent experienced clinicians. On the day of debonding, directly following retainer bonding, intraoral scans were performed (T0). The patients were invited for repeating the scans after 1 (T1), 3 (T2) and 6 months (T3). The displacements were assessed by superimposition of the scans. The patients were recommended to wear removable retainers 22h/day. They were instructed to immediately report a failure and to apply immediately to the office in case of failure.', 'interventionNames': ['Diagnostic Test: Intraoral scan']}], 'interventions': [{'name': 'Intraoral scan', 'type': 'DIAGNOSTIC_TEST', 'description': 'On the day of debonding, directly following retainer bonding, intraoral scans were performed (T0), using 3Shape Trios 4 (3Shape, Copenhagen, Denmark). The scans were repeated after a month. The patients were invited for repeating the scans after 1 (T1), 3 (T2) and 6 months (T3).', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70-111', 'city': 'Szczecin', 'state': 'West Pomeranian Voivodeship', 'country': 'Poland', 'facility': 'Department of Interdisciplinary Dentistry, Pomeranian Medical Univeristy in Szczecin', 'geoPoint': {'lat': 53.42894, 'lon': 14.55302}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pomeranian Medical University Szczecin', 'class': 'OTHER'}, 'collaborators': [{'name': '3Shape Poland Sp.z.o.o.', 'class': 'UNKNOWN'}, {'name': 'Koszalin University of Technology', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}