Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-02-21 @ 1:02 PM
Study NCT ID:
NCT05500456
Status:
COMPLETED
Last Update Posted:
2022-08-15
First Post:
2022-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness of Clear Aligner and Traditional Fixed Appliances in Achieving Good Occlusion in Complex Orthodontic Cases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008310', 'term': 'Malocclusion'}, {'id': 'D003441', 'term': 'Crowding'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D013037', 'term': 'Spatial Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, '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': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-11', 'studyFirstSubmitDate': '2022-08-11', 'studyFirstSubmitQcDate': '2022-08-11', 'lastUpdatePostDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in PAR index', 'timeFrame': 'T0: one day before the commencement of treatment. T1: one day following the end of treatment', 'description': "The PAR index will be used to provide objective assessment of treatment success. Each set of dental models prepared before and after treatment for each case will be occluded in maximum intercuspation and a calibrated PAR ruler is used to assign a value to each of the PAR index components: contact displacement in the upper and lower labial segment (UAS), overjet (OJ), overbite (OB), medline deviation (MID) and right and left buccazzzl occlusion (RBO, LBO). The score of each component is summed up to a total PAR score. A reduction in the PAR score of at least 30% classifies the case as 'improved'. A reduction of 22 points or more in the weighted PAR score classifies the case as 'greatly improved'. Improvements smaller than 30% are declared as 'worse or no different'"}, {'measure': "Changes in Little's irregularity index", 'timeFrame': 'T0: one day before the commencement of treatment. T1: one day following the end of treatment', 'description': "The Little's index measures the linear displacements in the horizontal plane between the contact points of the anterior teeth from the mesial surface of one canine to the contralateral one. The LII score is the sum of these linear measurements, and a higher score value indicates more severe irregularities of the anterior teeth"}], 'secondaryOutcomes': [{'measure': 'Treatment time', 'timeFrame': 'T1: one day following the end of treatment', 'description': 'The treatment duration was calculated by months and will be compared between the groups'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Clear aligners', 'PAR index', 'Vestibular fixed appliances', 'Orthodontics', 'Crowding', 'Treatment duration'], 'conditions': ['Crowding, Tooth']}, 'referencesModule': {'references': [{'pmid': '35663697', 'type': 'BACKGROUND', 'citation': 'Jaber ST, Hajeer MY, Burhan AS, Latifeh Y. The Effect of Treatment With Clear Aligners Versus Fixed Appliances on Oral Health-Related Quality of Life in Patients With Severe Crowding: A One-Year Follow-Up Randomized Controlled Clinical Trial. Cureus. 2022 May 30;14(5):e25472. doi: 10.7759/cureus.25472. eCollection 2022 May.'}, {'pmid': '33258297', 'type': 'BACKGROUND', 'citation': 'Jaber ST, Hajeer MY, Khattab TZ, Mahaini L. Evaluation of the fused deposition modeling and the digital light processing techniques in terms of dimensional accuracy of printing dental models used for the fabrication of clear aligners. Clin Exp Dent Res. 2021 Aug;7(4):591-600. doi: 10.1002/cre2.366. Epub 2020 Nov 30.'}, {'pmid': '26221410', 'type': 'BACKGROUND', 'citation': 'Li W, Wang S, Zhang Y. The effectiveness of the Invisalign appliance in extraction cases using the the ABO model grading system: a multicenter randomized controlled trial. Int J Clin Exp Med. 2015 May 15;8(5):8276-82. eCollection 2015.'}, {'pmid': '28670875', 'type': 'BACKGROUND', 'citation': 'Liu S, Oh H, Chambers DW, Baumrind S, Xu T. Validity of the American Board of Orthodontics Discrepancy Index and the Peer Assessment Rating Index for comprehensive evaluation of malocclusion severity. Orthod Craniofac Res. 2017 Aug;20(3):140-145. doi: 10.1111/ocr.12195. Epub 2017 Jul 3.'}, {'pmid': '21027613', 'type': 'BACKGROUND', 'citation': 'KESLING HD. Coordinating the predetermined pattern and tooth positioner with conventional treatment. Am J Orthod Oral Surg. 1946 May;32:285-93. doi: 10.1016/0096-6347(46)90053-1. No abstract available.'}]}, 'descriptionModule': {'briefSummary': "Patients who have severe crowding that requires four premolars extraction will be treated in this study. The efficacy and effectiveness of in-house clear aligners therapy compared with vestibular fixed appliances in the treatment of severe crowding malocclusion cases requiring the extraction of first premolars will be evaluated using Little's irregularity index (LII), Peer assessment rating index (PAR), and treatment duration.\n\nThere are two groups:\n\nFirst group (Experimental): the patients in this group will be treated using clear aligners.\n\nSecond group (Control): the patients in this group will be treated using fixed appliances.", 'detailedDescription': 'For years, orthodontists and dentists have used removable appliances for orthodontic treatment. With the CAD/CAM technology, clear aligners treat a broader range of cases with greater precision. They consist of a series of plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom-manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for about two weeks, then replaced by the next in the series until the final position is achieved.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Class I skeletal and dental malocclusion\n* severe crowding (more than 6 mm of tooth size-arch length discrepancy)\n* Good oral hygiene and periodontal health.\n* No congenitally missing or extracted teeth (except for the third molars).\n* No history of previous trauma to the maxillofacial region or surgical interventions.\n\nExclusion Criteria:\n\n* Subject with psychological abnormalities.\n* Subject with systemic diseases.\n* Previous orthodontic treatment.\n* Subject has known allergy to latex and plastic'}, 'identificationModule': {'nctId': 'NCT05500456', 'briefTitle': 'The Effectiveness of Clear Aligner and Traditional Fixed Appliances in Achieving Good Occlusion in Complex Orthodontic Cases', 'organization': {'class': 'OTHER', 'fullName': 'Damascus University'}, 'officialTitle': 'Evaluation of the Achieved Occlusal Relationships Using the PAR Index Between the In-house Constructed Clear Aligners and Fixed Appliances in Patients With Extraction-based Treatment Plans: A Randomized Control Clinical Trial', 'orgStudyIdInfo': {'id': 'UDDS-Ortho-13-2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clear aligners', 'description': 'The patients in this group will be treated using clear aligners.', 'interventionNames': ['Device: Clear aligners']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fixed appliances.', 'description': 'The patients in this group will be treated using fixed appliances.', 'interventionNames': ['Device: Fixed appliances']}], 'interventions': [{'name': 'Clear aligners', 'type': 'DEVICE', 'description': 'Each aligner will be worn for about two weeks, and then replaced by the next in the series until the final position is achieved.', 'armGroupLabels': ['Clear aligners']}, {'name': 'Fixed appliances', 'type': 'DEVICE', 'description': 'Conventional wires and brackets will be used.', 'armGroupLabels': ['Fixed appliances.']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Damascus', 'country': 'Syria', 'facility': 'University of Damascus', 'geoPoint': {'lat': 33.5102, 'lon': 36.29128}}], 'overallOfficials': [{'name': 'Samer T Jaber, DDS,MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of orthodontics, Damascus University, Syria'}, {'name': 'Mohammad Y Hajeer, DDS,MSc,PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor of Orthodontics, Department of Orthodontics, University of Damascus Dental School, Damascus, Syria.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Damascus University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}