Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2025-12-30 @ 6:17 AM
Study NCT ID:
NCT04808557
Status:
COMPLETED
Last Update Posted:
2021-05-11
First Post:
2021-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SEM Evaluation of the Quantity of microRepair® on Resin Composite Surfaces: an in Vivo Randomized Clinical Trial.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Volunteers will have buttons bonded on the vestibular surfaces of elements 1.4,1.5,1.6. Then, they will be randomly divided into two groups: Trial Group will use Biorepair Total Protection toothpaste for home oral care, whereas Control Group will use Sensodyne Repair \\& Protect for home oral care.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-10', 'studyFirstSubmitDate': '2021-03-16', 'studyFirstSubmitQcDate': '2021-03-17', 'lastUpdatePostDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '% microRepair® on composite surfaces', 'timeFrame': '7 days from the bonding procedure.', 'description': 'SEM evaluation of the percentage of microRepair® on composite surfaces.'}, {'measure': '% microRepair® on composite surfaces', 'timeFrame': '15 days from the bonding procedure.', 'description': 'SEM evaluation of the percentage of microRepair® on composite surfaces.'}, {'measure': '% microRepair® on composite surfaces', 'timeFrame': '30 days from the bonding procedure.', 'description': 'SEM evaluation of the percentage of microRepair® on composite surfaces.'}, {'measure': 'Comparison with Control Group', 'timeFrame': '7 days from the bonding procedure.', 'description': 'SEM evaluation of the possibile differences between Trial and Control Groups.'}, {'measure': 'Comparison with Control Group', 'timeFrame': '15 days from the bonding procedure.', 'description': 'SEM evaluation of the possibile differences between Trial and Control Groups.'}, {'measure': 'Comparison with Control Group', 'timeFrame': '30 days from the bonding procedure.', 'description': 'SEM evaluation of the possibile differences between Trial and Control Groups.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Composite resins', 'Toothpastes', 'Orthodontic buttons'], 'conditions': ['Dental Caries', 'Dental Fillings']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the quantity of Biorepair Total Protection toothpaste on composite surfaces inside oral cavity. Three orthodontic lingual buttons are bonded on the vestibular surfaces of upper right premolars (1.4 and 1.5) and upper right first molars (1.6) of volunteers. A composite resine is applied upon them. Then, after 7 days, 1.4 button will be debonded; after 15 days, 1.5 button are debonded; in the end, after 30 days the last button (1.6) is debonded. The buttons will be stored in sterile environment and then sent to laboratory for SEM evaluation.', 'detailedDescription': 'Orthodontic buttons are bonded on the vestibular surfaces of the upper right premolars (1.4 and 1.5) and the upper right first molar (1.6). A composite resin is polymerized on the top of the buttons. Then, participants are divided into two groups.\n\n* Trial Group: participants from this group will receive a manual toothbrush and Biorepair Total Protection toothpaste for home oral hygiene after lunches.\n* Control Groups: participants from this group will receive a manual toothbrush and Sensodyne Repair \\& Protect for home oral hygiene after lunches.\n\nAfter 7 days from the procedure of bonding, the buttons on upper right first premolars (1.4) are debonded. After 15 days from the procedure of bonding, the buttons on upper right second premolars (1.5) are debonded. In the end, After 30 days from the procedure of bonding, the buttons on upper right first molars (1.6) are debonded.\n\nDebonded buttons are then stored in sterile environment at 2-3°C temperature; successively, they are sent to laboratory for SEM evaluation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients\n* No current orthodontic treatment during the study\n* No use of occlusal splint or retention device\n\nExclusion Criteria:\n\n* Presence of white spot lesions on the vestibular surfaces of teeth\n* Corrupted vestibular surfaces of teeth'}, 'identificationModule': {'nctId': 'NCT04808557', 'briefTitle': 'SEM Evaluation of the Quantity of microRepair® on Resin Composite Surfaces: an in Vivo Randomized Clinical Trial.', 'organization': {'class': 'OTHER', 'fullName': 'University of Pavia'}, 'officialTitle': 'SEM Evaluation of the Quantity of microRepair® Contained in Biorepair Total Protection Toothpaste Residue on Composite Surfaces of Orthodontic Buttons: an in Vivo Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': '2021-BUTTONS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Trial Group', 'description': 'Volunteers from this group will have bonded buttons on vestibular surfaces of elements 1.4, 1.5 and 1.6. Then they will use Biorepair Total Protection for home oral care for 30 days. In this time period, the buttons will be respectively debonded at 7 (1.4), 15 (1.5) and 30 (1.6) days after the bonding procedures, in order to be evaluated at SEM.', 'interventionNames': ['Other: Biorepair Total Protection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Volunteers from this group will have bonded buttons on vestibular surfaces of elements 1.4, 1.5 and 1.6. Then they will use Sensodyne Repair \\& Protect for home oral care for 30 days. In this time period, the buttons will be respectively debonded at 7 (1.4), 15 (1.5) and 30 (1.6) days after the bonding procedures, in order to be evaluated at SEM.', 'interventionNames': ['Other: Sensodyne Repair & Protect']}], 'interventions': [{'name': 'Biorepair Total Protection', 'type': 'OTHER', 'description': 'Volunteers will use Biorepair Total Protection for home oral hygiene for the following 30 days from the bonding procedure.', 'armGroupLabels': ['Trial Group']}, {'name': 'Sensodyne Repair & Protect', 'type': 'OTHER', 'description': 'Volunteers will use Sensodyne Repair \\& Protect for home oral hygiene for the following 30 days from the bonding procedure.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27100', 'city': 'Pavia', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}], 'overallOfficials': [{'name': 'Andrea Scribante, DDS, PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pavia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will be available upon motivated request to Principal Investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pavia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Resident, Principal Investigator', 'investigatorFullName': 'Andrea Scribante', 'investigatorAffiliation': 'University of Pavia'}}}}