Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT06165458
Status:
COMPLETED
Last Update Posted:
2023-12-15
First Post:
2023-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Whitening Efficacy and Tooth Sensitivity of Different Concentrations of Hydrogen Peroxide Photoactivated With Violet or Blue LEDs
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': 'OTHER', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-09', 'studyFirstSubmitDate': '2023-12-02', 'studyFirstSubmitQcDate': '2023-12-02', 'lastUpdatePostDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Color', 'timeFrame': 'Color assessment was carried out before bleaching, 1 week after bleaching and 3 months after bleaching', 'description': 'A operator measured the color of the six upper anterior teeth using a digital spectrophotometer (VITA Easyshade V, Wilcos, Petrópolis, RJ, Brazil).'}, {'measure': 'Bleaching Sensitivity', 'timeFrame': 'Assessments were carried out three times: before bleaching, immediately after bleaching, and 24 hours after bleaching.', 'description': 'The degree of tooth sensitivity of patients was recorded using a visual analogue scale (VAS) from 0 to 10, where 0 represents no tooth sensitivity and 10 represents the greatest tooth sensitivity ever felt by the patient.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Color', 'Bleaching Sensitivity']}, 'referencesModule': {'references': [{'pmid': '39060473', 'type': 'DERIVED', 'citation': 'Oliveira MGVV, Dutra DJB, Costa JLSG, Besegato JF, Barros APO, Oliveira RR, Araujo PV, Alvim HH. Clinical comparison of whitening efficacy and tooth sensitivity of different concentrations of hydrogen peroxide photoactivated with violet or blue LEDs. Lasers Med Sci. 2024 Jul 26;39(1):195. doi: 10.1007/s10103-024-04144-6.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, controlled, double-blind and repeated-measures clinical trial evaluated the photoactivation of hydrogen peroxide gels in different concentrations with blue or violet LED in terms of whitening efficacy and tooth sensitivity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* at age 18 or older, with good general and oral health;\n* possessing all six natural and healthy upper anterior teeth with a color shade of A2 or darker, determined by comparison with the Vita Classic scale;\n\nExclusion Criteria:\n\n* pregnant and breastfeeding women;\n* individuals with internal tooth discoloration (tetracycline stains, fluorosis or hypoplasias);\n* smokers, or those with veneers or restorations on the teeth in questions were excluded;\n* gingival recession;\n* dentin exposure;\n* periodontal disease.'}, 'identificationModule': {'nctId': 'NCT06165458', 'briefTitle': 'Whitening Efficacy and Tooth Sensitivity of Different Concentrations of Hydrogen Peroxide Photoactivated With Violet or Blue LEDs', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal do Para'}, 'officialTitle': 'Clinical Comparison of Whitening Efficacy and Tooth Sensitivity of Different Concentrations of Hydrogen Peroxide Photoactivated With Violet or Blue LEDs', 'orgStudyIdInfo': {'id': 'UFPara017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HP6V', 'description': '6% hydrogen peroxide gel + violet LED', 'interventionNames': ['Other: 6% hydrogen peroxide gel + violet LED']}, {'type': 'EXPERIMENTAL', 'label': 'HP6B', 'description': '6% hydrogen peroxide gel + blue LED', 'interventionNames': ['Other: 6% hydrogen peroxide gel + blue LED']}, {'type': 'EXPERIMENTAL', 'label': 'HP35V', 'description': '35% hydrogen peroxide gel + violet LED', 'interventionNames': ['Other: 35% hydrogen peroxide gel + violet LED']}, {'type': 'EXPERIMENTAL', 'label': 'HP35B', 'description': '35% hydrogen peroxide gel + blue LED', 'interventionNames': ['Other: 35% hydrogen peroxide gel + blue LED']}], 'interventions': [{'name': '6% hydrogen peroxide gel + violet LED', 'type': 'OTHER', 'description': 'Tooth whitening with 6% hydrogen peroxide gel (Lase Peroxide Lite, DMC, São Carlos, Brazil) activated by violet LED', 'armGroupLabels': ['HP6V']}, {'name': '6% hydrogen peroxide gel + blue LED', 'type': 'OTHER', 'description': 'Tooth whitening with 6% hydrogen peroxide gel (Lase Peroxide Lite, DMC, São Carlos, Brazil) activated by blue LED', 'armGroupLabels': ['HP6B']}, {'name': '35% hydrogen peroxide gel + violet LED', 'type': 'OTHER', 'description': 'Tooth whitening with 35% hydrogen peroxide gel (Lase Peroxide Sensy, DMC, São Carlos, Brazil) activated by violet LED', 'armGroupLabels': ['HP35V']}, {'name': '35% hydrogen peroxide gel + blue LED', 'type': 'OTHER', 'description': 'Tooth whitening with 35% hydrogen peroxide gel (Lase Peroxide Sensy, DMC, São Carlos, Brazil) activated by blue LED', 'armGroupLabels': ['HP35B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66075-110', 'city': 'Belém', 'state': 'Pará', 'country': 'Brazil', 'facility': 'Federal University of Pará', 'geoPoint': {'lat': -1.45583, 'lon': -48.50444}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal do Para', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'clinical professor', 'investigatorFullName': 'Cecy Martins Silva', 'investigatorAffiliation': 'Universidade Federal do Para'}}}}