Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-26 @ 5:01 AM
Study NCT ID:
NCT05660668
Status:
UNKNOWN
Last Update Posted:
2023-01-04
First Post:
2022-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Assessment of Failure Rate of Fixed Lingual Retainer Between Two Types of Light Cured Resin Composite
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C481385', 'term': 'Transbond LR'}, {'id': 'C477790', 'term': 'Transbond XT'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-01', 'studyFirstSubmitDate': '2022-12-13', 'studyFirstSubmitQcDate': '2022-12-13', 'lastUpdatePostDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Failure rate( detachment rate) of fixed lingual retainer', 'timeFrame': 'the patient will be inspected after applying the fixed retainer every month for 6 months', 'description': 'measured by inspection of any detachment partial or complete of the fixed lingual retainer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Orthodontic Retainer']}, 'descriptionModule': {'briefSummary': 'The study will be performed on human subjects with finished orthodontic treatment to see the failure rate(detachment) of fixed lingual retainer between two types of light cure resin composite', 'detailedDescription': 'The study consists of two groups, the intervention involve performing bonding of fixed lingual retainer with light cured composite Transbond LR which is manufactured specific for the fixed lingual retainer while the control group involve bonding of fixed lingual retainer by light cured composite Transbond XT with follow up every month for 6 month to see the failure rate(detachment) between the two types of composite'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient at the end of an orthodontic treatment requiring the subsequent application of a lingual and palatal fixed retainer\n* good oral hygiene\n* medically free\n\nExclusion Criteria:\n\n* Facial trauma\n* onychophagia\n* habit of biting pencils or pens\n* tooth mobility'}, 'identificationModule': {'nctId': 'NCT05660668', 'briefTitle': 'Comparative Assessment of Failure Rate of Fixed Lingual Retainer Between Two Types of Light Cured Resin Composite', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Comparative Assessment of Failure Rate of Fixed Lingual Retainer in Finished Orthodontic Cases Between Two Types of Light Cured Resin Composite. A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'ORTHO 3-3-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transbond LR', 'description': 'in finished orthodontic cases a light cured resin composite (Transbond LR) will be added on fixed lingual retainer to see the failure rate (detachment) with follow up every month for 6 months', 'interventionNames': ['Other: Transbond LR']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Transbond XT', 'description': 'in finished orthodontic cases a light cured resin composite (Transbond XT) will be added on fixed lingual retainer to see the failure rate (detachment) with follow up every month for 6 months', 'interventionNames': ['Other: Transbond XT']}], 'interventions': [{'name': 'Transbond LR', 'type': 'OTHER', 'otherNames': ['3m brand'], 'description': 'cleaning the lingual surface using oil free pumice then apply acid etch 35% phosphoric acid for 20 second then rinse then Transbond LR will be applied directly on the fixed retainer and lingual surface of the teeth then light cured.', 'armGroupLabels': ['Transbond LR']}, {'name': 'Transbond XT', 'type': 'OTHER', 'otherNames': ['3m brand'], 'description': 'cleaning the lingual surface using oil free pumice then apply acid etch 35% phosphoric acid for 20 second then rinse then Transbond XT will be applied directly on the fixed retainer and lingual surface of the teeth then light cured.', 'armGroupLabels': ['Transbond XT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'Cairo unversity ,Faculty of dentistry', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mohamed Saied, BDS', 'role': 'CONTACT', 'email': 'mohamedsaied@dentistry.cu.edu.eg', 'phone': '0021003945733'}, {'name': 'Heba Dehis, lecturer', 'role': 'CONTACT', 'email': 'heba.dehis@dentistry.cu.edu.eg', 'phone': '0021020490611'}], 'overallOfficials': [{'name': 'Fady Hussein, Assoc. prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo unversity'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principle investigator', 'investigatorFullName': 'Mohamed Mohamed Saied', 'investigatorAffiliation': 'Cairo University'}}}}