Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-04-23 @ 3:01 PM
Study NCT ID:
NCT06410105
Status:
COMPLETED
Last Update Posted:
2024-05-10
First Post:
2024-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Orthodontic Treatment With Clear Aligner
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': ': Crossover Assignment A randomized, controlled, crossover, double-blind clinical study, Comparison of'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-08', 'studyFirstSubmitDate': '2024-05-04', 'studyFirstSubmitQcDate': '2024-05-08', 'lastUpdatePostDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'treatment with clear aligners', 'timeFrame': 'two years', 'description': 'to determine the root resorption for upper anterior teeth following treatment with clear aligners orthodontic appliances CA comparison with fixed appliances using CBCT.)'}], 'secondaryOutcomes': [{'measure': 'comparative study of Buccolingual Inclination changes', 'timeFrame': 'two years', 'description': 'to evaluate the Buccolingual Inclination changes and for upper anterior teeth following treatment with clear aligners orthodontic appliances CA comparison with fixed appliances using CBCT.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Orthodontic, clear aligners, fixed appliances, CBCT'], 'conditions': ['Orthodontic Pathological Resorption of External Root']}, 'descriptionModule': {'briefSummary': 'Three-dimensional Assessment of Root Resorption following treatment with clear aligners using Cone Beam Computed Tomography Design: A randomized, controlled, crossover, double-blind clinical study including twenty six adult , aged 18-25 years old.', 'detailedDescription': 'Orthodontically induced root resorption is one of the common undesirable sequalae of orthodontic treatment. one third of the patients treated with fixed appliances showed more than 3 mm of root resorption whereas at least 2% of orthodontic patients showed more than 5 mm of root resorption.\n\nThere is a controversy in the literature regarding the effect of clear aligners on apical root resorption. One previous study reported that some kinds of removable aligners may have the potential of minimizing orthodontic ally induced root resorption due to the studied piezoelectric property by these materials Till now, the degree of apical root resorption following treatment with (in house) aligners has not been reported in the literature.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe Clinical Diagnosis the age of patients ranges between 18-25 years, medium crowding between 3-6 mm in the area of the upper anterior teeth according to Little irregularity index 20,class1 according angel classification healthy patient No previous orthodontic treatment vital teeth with periodontal tissue without root absorption,\n\nExclusion Criteria:\n\nPrevious history of orthodontic or orthopedic treatment. Presence of craniofacial anomalies. Presence of any signs and symptoms of gingival and periodontal diseases. Presence of significant medical history (including drug allergy). Pregnant and lactating women'}, 'identificationModule': {'nctId': 'NCT06410105', 'briefTitle': 'Orthodontic Treatment With Clear Aligner', 'organization': {'class': 'OTHER', 'fullName': 'Tishreen University'}, 'officialTitle': 'Three-dimensional Assessment of Root Resorption Following Treatment With Clear Aligners Using Cone Beam Computed Tomography', 'orgStudyIdInfo': {'id': 'Tishreen U _orthodontic'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Groub(1): 13 patient treated with CLEAR ALIGNERS', 'description': 'The CA group included 13 patients treated with clear aligners Tree-dimensional images were captured using a CBCT scan (KaVo® Dental GmbH, Bismarckring, Germany). Te pre-treatment imaging parameters were 120 kV, 5 mA, 0.3 mm voxel size, and a feld of view of 230×170 mm', 'interventionNames': ['Device: CLEAR ALIGNERS']}, {'type': 'EXPERIMENTAL', 'label': 'Groub(2): 13 patient treated with a fixed orthodontic', 'description': '. The FA group included 13 patients treated with a fxed orthodontic appliance (american orthodontics, WI.Sheboygam, USA). Tree-dimensional images were captured using a CBCT scan (KaVo® Dental GmbH, Bismarckring, Germany). Te pre-treatment imaging parameters were 120 kV, 5 mA, 0.3 mm voxel size, and a feld of view of 230×170 mm, which', 'interventionNames': ['Device: CLEAR ALIGNERS']}], 'interventions': [{'name': 'CLEAR ALIGNERS', 'type': 'DEVICE', 'description': 'The CA group included 13 patients treated with clear aligners Tree-dimensional images were captured using a CBCT scan (KaVo® Dental GmbH, Bismarckring, Germany). Te pre-treatment imaging parameters were 120 kV, 5 mA, 0.3 mm voxel size, and a feld of view of 230×170 mm', 'armGroupLabels': ['Groub(1): 13 patient treated with CLEAR ALIGNERS', 'Groub(2): 13 patient treated with a fixed orthodontic']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Latakia', 'country': 'Syria', 'facility': 'Tishreen University', 'geoPoint': {'lat': 35.53125, 'lon': 35.79088}}], 'overallOfficials': [{'name': 'fadi khalil, prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Tishreen University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['ICF'], 'timeFrame': '9 month', 'ipdSharing': 'YES', 'description': 'study protocol ,Informed Consent From'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tishreen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}