Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT05121220
Status:
UNKNOWN
Last Update Posted:
2022-05-09
First Post:
2021-10-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Cost-effectiveness of Orthodontic Retention Protocols
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-05-08', 'releaseDate': '2023-11-18'}], 'estimatedResultsFirstSubmitDate': '2023-11-18'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077744', 'term': 'Orthodontic Appliances, Fixed'}], 'ancestors': [{'id': 'D009967', 'term': 'Orthodontic Appliances'}, {'id': 'D009970', 'term': 'Orthodontics'}, {'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 152}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-11-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-03', 'studyFirstSubmitDate': '2021-10-02', 'studyFirstSubmitQcDate': '2021-11-03', 'lastUpdatePostDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'incidence of relapse at 2 years', 'timeFrame': '2 years', 'description': 'the unabbreviated scale title: percentage of relapsed cases; the minimum and maximum values 0%,100%, higher scores mean a worse outcome, lower scores mean a better outcome'}, {'measure': 'incidence of relapse at 3 years', 'timeFrame': '3 years', 'description': 'the unabbreviated scale title: percentage of relapsed cases; the minimum and maximum values 0%,100%, higher scores mean a worse outcome, lower scores mean a better outcome'}, {'measure': 'extent of gingivitis at 2 years', 'timeFrame': '2 years', 'description': 'the unabbreviated scale title: Bleeding on probing (BOP)-ratio of measuring sites in mandibular central sextant; the minimum and maximum values 0%,100%, higher scores mean a worse outcome, lower scores mean a better result'}, {'measure': 'extent of gingivitis at 3 years', 'timeFrame': '3 years', 'description': 'the unabbreviated scale title: Bleeding on probing (BOP)-ratio of measuring sites in mandibular central sextant; the minimum and maximum values 0%,100%, higher scores mean a worse outcome, lower scores mean a better result'}, {'measure': 'duration of orthodontic treatment in months', 'timeFrame': '1 year', 'description': 'the unabbreviated scale title: numerical rating scale the minimum and maximum values: 0,30'}, {'measure': 'satisfaction with stability of results in retention period', 'timeFrame': '3 years', 'description': 'Participant\'s satisfaction with stability of results as assessed using a 5-point Likert scale. Scores range from "very unsatisfied" (1) to "very satisfied" (5). Higher scores mean a better outcome, lower scores mean a worse outcome'}, {'measure': 'costs total', 'timeFrame': '3 years', 'description': 'calculation of costs of retention: failures and new retainers in euros'}, {'measure': 'loss of productivity', 'timeFrame': '3 years', 'description': 'the unabbreviated scale title: number of check-ups in retention period; the minimum and maximum values 0,10; higher scores mean a worse outcome, lower scores mean a better result the minimum and maximum values: 0,30'}], 'primaryOutcomes': [{'measure': 'severity of relapse (unexpected tooth movement in mandibular frontal area) at 1 year', 'timeFrame': '1 year', 'description': 'the unabbreviated scale title: Little Irregularity Index (used to measure the crowding)- numerical rating scale in millimeters the minimum and maximum values: 0,10 higher scores mean a worse outcome lower scores mean a better outcome'}, {'measure': 'severity of relapse (unexpected tooth movement in mandibular frontal area) at 2 years', 'timeFrame': '2 years', 'description': 'the unabbreviated scale title: Little Irregularity Index (used to measure the crowding)- numerical rating scale in millimeters the minimum and maximum values: 0,10 higher scores mean a worse outcome lower scores mean a better outcome'}, {'measure': 'severity of relapse (unexpected tooth movement in mandibular frontal area) at 3 years', 'timeFrame': '3 years', 'description': 'the unabbreviated scale title: Little Irregularity Index (used to measure the crowding)- numerical rating scale in millimeters the minimum and maximum values: 0,10 higher scores mean a worse outcome lower scores mean a better outcome'}, {'measure': 'incidence of retainer failure (debonding, breakage) at 2 years', 'timeFrame': '2 years', 'description': 'percentage of cases with at least one fixed retainer failure, the minimum and maximum values 0%,100% higher scores mean a worse outcome, lower scores mean a better result'}, {'measure': 'incidence of retainer failure (debonding, breakage) at 3 years', 'timeFrame': '3 years', 'description': 'percentage of cases with at least one fixed retainer failure, the minimum and maximum values 0%,100% higher scores mean a worse outcome, lower scores mean a better result'}, {'measure': 'extent of biofilm accumulation at 2 years', 'timeFrame': '2 years', 'description': 'the unabbreviated scale title: Silness and Loe Plaque Index-ratio of measuring sites in mandibular central sextant; the minimum and maximum values 0%,100%, higher scores mean a worse outcome, lower scores mean a better result'}, {'measure': 'extent of biofilm accumulation at 3 years', 'timeFrame': '3 years', 'description': 'the unabbreviated scale title: Silness and Loe Plaque Index-ratio of measuring sites in mandibular central sextant; the minimum and maximum values 0%,100%, higher scores mean a worse outcome, lower scores mean a better result'}], 'secondaryOutcomes': [{'measure': 'incidence of intercanine width change', 'timeFrame': '3 years', 'description': 'percentage of cases with intercanine width change, the minimum and maximum values 0%,100% higher scores mean a worse outcome, lower scores mean a better result'}, {'measure': 'changes of intercanine width', 'timeFrame': '2 years, 3 years', 'description': 'the unabbreviated scale title: intercanine width change in millimeters, the minimum and maximum values 0,5, higher scores mean a worse outcome, lower result mean a better outcome'}, {'measure': 'extent of calculus accumulation at 2 years', 'timeFrame': '2 years', 'description': 'the unabbreviated scale title: Calculus Surface Index (CSI)-ratio of measuring sites in mandibular central sextant; the minimum and maximum values 0%,100%, higher scores mean a worse outcome, lower scores mean a better outcome'}, {'measure': 'extent of calculus accumulation at 3 years', 'timeFrame': '3 years', 'description': 'the unabbreviated scale title: Calculus Surface Index (CSI)-ratio of measuring sites in mandibular central sextant; the minimum and maximum values 0%,100%, higher scores mean a worse outcome, lower scores mean a better outcome'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['retention wire', 'fixed retainer', 'orthodontic therapy'], 'conditions': ['Orthodontic Relapse']}, 'referencesModule': {'references': [{'pmid': '38424224', 'type': 'DERIVED', 'citation': 'Kanizaj Ugrin S, Spalj S. Comparison of efficacy of thermoplastic retainer with round and rectangular bonded lingual wire retainer in the mandible two years after orthodontic treatment: a randomised controlled trial. Clin Oral Investig. 2024 Mar 1;28(3):183. doi: 10.1007/s00784-024-05572-y.'}]}, 'descriptionModule': {'briefSummary': 'Objective is to assess changes of dentition and periodontium, and hygiene in retention after the end of the active phase of orthodontic treatment, and relationship with gender, type of retention appliance, pre-therapeutic condition of dentition and duration of active phase of treatment.', 'detailedDescription': 'A total of 152 subjects will be recruited and randomly assigned into three groups. First group will have a square 8-stranded 0.673x0.268 mm retainer wire bonded in mandibular teeth after completing the active phase of comprehensive orthodontic treatment with fixed appliances. Retainer will be bonded on lingual site canine to canine on each tooth. Second group will have a round 6-stranded 0.40 mm retainer in mandible. Third group will be without fixed retainer, only with thermoplastic vacuum-formed removable Essix retainer in mandible.\n\nSubjects will be examined before orthodontic treatment (T0), upon completion of treatment (T1), six months in retention (T2), two years (T3) and three years in retention (T4). Changes in intercanine width, relapse (unexpected tooth movements), retainer failure, accumulation of biofilm, calculus and gingivitis will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '11 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: finished orthodontic treatment, participants must have all permanent teeth Exclusion Criteria: hypodontia, missing teeth'}, 'identificationModule': {'nctId': 'NCT05121220', 'acronym': 'orthoretenti', 'briefTitle': 'Efficacy and Cost-effectiveness of Orthodontic Retention Protocols', 'organization': {'class': 'OTHER', 'fullName': 'Poliklinika Orthonova'}, 'officialTitle': 'Efficacy and Cost-effectiveness of Orthodontic Retention Protocols', 'orgStudyIdInfo': {'id': '66771011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'fixed mandibular lingual rectangular retainer 0.673 x 0.268 mm', 'description': '0.673 x 0.268 mm 8-stranded wire Bond A Braid (Reliance Orthodontic Products, USA) will be bonded in mandible canine to canine on each tooth using Filtek flowable composite (Ivoclar Vivadent, Lichtenstein) and Multilink adhesive (3M, USA).', 'interventionNames': ['Device: fixed retainer']}, {'type': 'EXPERIMENTAL', 'label': 'fixed mandibular lingual round retainer 0.40 mm', 'description': '0.40 mm round 6-stranded wire (Forestadent, Germany) will be bonded on 6 mandibular frontal teeth, canine to canine on each tooth using Filtek flowable composite (Ivoclar Vivadent, Lichtenstein) and Multilink adhesive (3M, USA).', 'interventionNames': ['Device: fixed retainer']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'removable mandibular retainer', 'description': 'Group without fixed retainer will be wearing removable thermoplastic vacuum-formed Essix retainer', 'interventionNames': ['Device: removable retainer']}], 'interventions': [{'name': 'fixed retainer', 'type': 'DEVICE', 'description': 'bonded lingual mandibular fixed retainer on frontal teeth 33-43', 'armGroupLabels': ['fixed mandibular lingual rectangular retainer 0.673 x 0.268 mm', 'fixed mandibular lingual round retainer 0.40 mm']}, {'name': 'removable retainer', 'type': 'DEVICE', 'description': 'thermoplastic vacuum-formed removable mandibular retainer', 'armGroupLabels': ['removable mandibular retainer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10000', 'city': 'Zagreb', 'status': 'RECRUITING', 'country': 'Croatia', 'contacts': [{'name': 'Silvija Kanižaj Ugrin, DMD', 'role': 'CONTACT', 'email': 'kanizaj.ugrin@gmail.com', 'phone': '+385915232860'}], 'facility': 'Poliklinika Orthonova', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}], 'centralContacts': [{'name': 'Silvija Kanižaj Ugrin, DDM', 'role': 'CONTACT', 'email': 'kanizaj.ugrin@gmail.com', 'phone': '00385915232860'}, {'name': 'Stjepan Špalj, PhD', 'role': 'CONTACT', 'email': 'stjepan.spalj@fdmri.uniri.hr', 'phone': '00385916119853'}], 'overallOfficials': [{'name': 'Silvija Kanižaj Ugrin, DDM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Poliklinika Orthonova'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'on request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poliklinika Orthonova', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Zagreb School of Dental Medicine, Zagreb, Croatia', 'class': 'UNKNOWN'}, {'name': 'University of Rijeka Faculty of Dental Medicine, Rijeka, Croatia', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dentist, Orthodontic specialist', 'investigatorFullName': 'silvija kanižaj ugrin', 'investigatorAffiliation': 'Poliklinika Orthonova'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-11-18', 'type': 'RELEASE'}, {'date': '2024-05-08', 'type': 'RESET'}], 'unpostedResponsibleParty': 'silvija kanižaj ugrin, Dentist, Orthodontic specialist, Poliklinika Orthonova'}}}}