Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-02-26 @ 12:01 PM
Study NCT ID:
NCT05644860
Status:
UNKNOWN
Last Update Posted:
2022-12-09
First Post:
2022-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nano Composites and Light Cure Composites - A Comparative Assessment of Bond Failure Rates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C444701', 'term': 'Filtek Z250'}, {'id': 'C477790', 'term': 'Transbond XT'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': "The two materials being compared look similar and according to the manufacturers' instructions they are applied using a similar protocol i.e. enamel conditioning, application of unfilled resin, placement of brackets and light curing. Hence the patient will not be able to identify as to which experimental group they are placed in."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The patients meeting the slection criteria chall be randomly allocated in two groups (A and B)/ Brackets in the group A shall be bonded with the conventional composite (Transbond XT, 3M Unitek, USA) with appreciably good shear bond strength. In patients belonging to group B, brackets shall be bonded with nanohybrid composite (Filtek Z250).\n\nLong term succes shall be evaluated by comparing the bracket failute rate between the two groups.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-30', 'studyFirstSubmitDate': '2022-11-30', 'studyFirstSubmitQcDate': '2022-11-30', 'lastUpdatePostDateStruct': {'date': '2022-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bracket failure rate', 'timeFrame': '6 months', 'description': 'Number of brackets detached from the tooth surface'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nanotechnology, Dental Materials, Composites']}, 'descriptionModule': {'briefSummary': 'This randomized clinical trial is aimed to evaluate the bond failure rates of the brackets bonded with nano-hybrid composites (Filtek Z250) to that of conventional composites (Transbond XT)', 'detailedDescription': 'Orthodontic brackets are attached to the teeth with a robust bonding material called composite resin, however sometimes the bond between the braket and the tooth surface may fail halting the desired tooth movement. Repeated bond failures like these are inconvenience both for the orthodontists as well as the patients. With each bracket loosening due to bond failure, treatment time is prolonged as the activation planned on eash visit is delayed resuling in increased treatment time.\n\nNanotechnology has recently made a breakthrough in dental materials through incorporation of nanoparticles. Composites containing nano-filler particles exhibit higher compression strength, flexural strength, elastic modulus and wear resistance (Rabia and Bilal). In vitro studies have shown that nanohbrid composites have shear bond stregnths similar to that of conventional composites however the environment of oral cavity is challenging and there are no long term clinical trials to validate these results.\n\nThe aim of this study is to compare the rate of bond failure between the brackets bonded with nano hybrid composites and that of the conventional composites over a period of six months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '35 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients having treatment with fixed metallic orthodontic appliances\n* Patients in whom both upper and lower arches are bonded in single visit\n\nExclusion Criteria:\n\n* Patients with variations in morphology of teeth\n* Patients with defective enamel, dentine and cementum\n* Patiens with parafunctioal habits\n* Patients with restorations involving the facial surface of teeth'}, 'identificationModule': {'nctId': 'NCT05644860', 'briefTitle': 'Nano Composites and Light Cure Composites - A Comparative Assessment of Bond Failure Rates', 'organization': {'class': 'OTHER', 'fullName': 'Foundation University Islamabad'}, 'officialTitle': 'Nano Composites and Light Cure Composites - A Comparative Assessment of Bond Failure Rates', 'orgStudyIdInfo': {'id': 'FUI/CTR/2022/19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Composite Group (Transbond XT)', 'description': 'Patients in which brackets will be bonded with conventional composite resin (Transbond XT)', 'interventionNames': ['Combination Product: Conventional Composite Group (Transbond XT)']}, {'type': 'EXPERIMENTAL', 'label': 'Nanohybrid Compisite Group (Filtek Z250)', 'description': 'Patients in which brackets will be bonded with nanohybrid composite resin (Filtek Z250)', 'interventionNames': ['Combination Product: Nanohybrid Compisite Group (Filtek Z250)']}], 'interventions': [{'name': 'Nanohybrid Compisite Group (Filtek Z250)', 'type': 'COMBINATION_PRODUCT', 'description': 'Orthodontic brackets shall be bonded with Nano hybrid composite', 'armGroupLabels': ['Nanohybrid Compisite Group (Filtek Z250)']}, {'name': 'Conventional Composite Group (Transbond XT)', 'type': 'COMBINATION_PRODUCT', 'description': 'Patients in which brackets will be bonded with conventional composite resin (Transbond XT)', 'armGroupLabels': ['Conventional Composite Group (Transbond XT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45720', 'city': 'Islamabad', 'state': 'Islamabad/ Federal', 'country': 'Pakistan', 'facility': 'Foundation University Islamabad', 'geoPoint': {'lat': 33.72148, 'lon': 73.04329}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Foundation University Islamabad', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}