Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2025-12-24 @ 4:43 PM
Study NCT ID:
NCT04149366
Status:
UNKNOWN
Last Update Posted:
2019-11-04
First Post:
2019-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical and Radiographic Evaluation of Different Thickness of Vacuum Formed Retainer (Essix Retainer) During Retention Phase After Orthodontic Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D018704', 'term': 'Orthodontic Retainers'}], 'ancestors': [{'id': 'D009967', 'term': 'Orthodontic Appliances'}, {'id': 'D009970', 'term': 'Orthodontics'}, {'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-10-29', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2020-10-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-30', 'studyFirstSubmitDate': '2019-10-27', 'studyFirstSubmitQcDate': '2019-10-30', 'lastUpdatePostDateStruct': {'date': '2019-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical effect of retainer on temporomandibular joint', 'timeFrame': '9 months', 'description': 'Absence of pain, deviation and trismus'}, {'measure': 'Radiographic effect of retainer on tempromandibular joint', 'timeFrame': '9 months', 'description': 'Normal dissc position'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Temporomandibular Joint Disorders After Using Essix Retainer']}, 'descriptionModule': {'briefSummary': 'vacuum formed retainer act as bite raiser that increase vertical dimension which may affect Tempromandibular joint and aim of this study is to perform clinical and radiographic evaluation of different thickness of vacuum formed retainer (Essix retainer) during retention phase after orthodontic treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '35 Years', 'minimumAge': '15 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients that have finished fixed orthodontic treatment with no signs or symptoms of temporomandibular joint disorders', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients finished fixed orthodontic treatment with no signs or symptoms of temporomandibular joint disorders\n* patients indicated for removable retainer\n\nExclusion Criteria:\n\n* any systemic disease\n* chronic medication uptake\n* bad oral hygiene pathological conditions of temporomandibular joint'}, 'identificationModule': {'nctId': 'NCT04149366', 'briefTitle': 'Clinical and Radiographic Evaluation of Different Thickness of Vacuum Formed Retainer (Essix Retainer) During Retention Phase After Orthodontic Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Clinical and Radiographic Evaluation of Different Thickness of Vacuum Formed Retainer (Essix Retainer) During Retention Phase After Orthodontic Treatment', 'orgStudyIdInfo': {'id': '295'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'group 1 (Wrapround retainer)', 'interventionNames': ['Device: Retainer']}, {'label': 'Group 2 (Essix retainer 1mm)'}, {'label': 'Group 3 (Essix retainer 1.5 mm)'}, {'label': 'Group 3 (Essix retainer 2mm)'}], 'interventions': [{'name': 'Retainer', 'type': 'DEVICE', 'description': 'Orthodontic retainer', 'armGroupLabels': ['group 1 (Wrapround retainer)']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer', 'investigatorFullName': 'Mostafa Ahmed', 'investigatorAffiliation': 'Minia University'}}}}