Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2026-01-02 @ 1:13 PM
Study NCT ID:
NCT04013659
Status:
UNKNOWN
Last Update Posted:
2019-07-10
First Post:
2019-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Gel Renewal During In-office Dental Bleaching
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Split-mouth model design'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 33}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2020-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-05', 'studyFirstSubmitDate': '2019-06-09', 'studyFirstSubmitQcDate': '2019-07-05', 'lastUpdatePostDateStruct': {'date': '2019-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Teeth Color 1', 'timeFrame': 'Immediately after treatment', 'description': 'assessed quantitatively by colorimetric color scale'}, {'measure': 'Teeth Color 2', 'timeFrame': 'Immediately after treatment', 'description': 'assessed quantitatively by spectrophotometry'}, {'measure': 'Teeth Color 1', 'timeFrame': '14 days after treatment', 'description': 'assessed quantitatively by colorimetric color scale'}, {'measure': 'Teeth Color 2', 'timeFrame': '14 days after treatment', 'description': 'assessed quantitatively by spectrophotometry'}, {'measure': 'Teeth Color 1', 'timeFrame': '2 months after treatment', 'description': 'assessed quantitatively by colorimetric color scale'}, {'measure': 'Teeth Color 2', 'timeFrame': '2 months after treatment', 'description': 'assessed quantitatively by spectrophotometry'}], 'secondaryOutcomes': [{'measure': 'Dental sensitivity', 'timeFrame': 'Immediately after treatment', 'description': 'Evaluated through a Visual Analogic Scale (0-10cm) from 0 (no pain) to 10 (maximum pain)'}, {'measure': 'Dental sensitivity', 'timeFrame': '14 days after treatment', 'description': 'Evaluated through a Visual Analogic Scale (0-10cm) from 0 (no pain) to 10 (maximum pain)'}, {'measure': 'Dental sensitivity', 'timeFrame': '2 months after treatment', 'description': 'Evaluated through a Visual Analogic Scale (0-10cm) from 0 (no pain) to 10 (maximum pain)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tooth Bleaching']}, 'descriptionModule': {'briefSummary': "Considering the lack of studies related to the violet LED light (405-410nm), applied to tooth whitening, as well as the lack of protocols for its use, this study aims to evaluate if bleaching gel renewal during dental office whitening associated with Violet LED light interferes with final color result and postoperative sensitivity in a randomized, blinded, split-mouth study. Thirty-three volunteers will be selected to participate in the study (n = 33), and the study groups will be: G1 (Permanence of the Whitening Gel on the tooth enamel for 15 minutes) and G2 (3 Whitening Gel renewal every 5 minutes - Total of 15 minutes). In both G1 and G2, teeth will be illuminated with the Violet LED (405-410nm). In the same patient the two treatments (G1 and G2) will be performed, with a split-mouth protocol. The primary outcome will be immediate and mediated color change, quantitatively assessed by colorimetric (color scale) and spectrophotometry tests. Dental sensitivity will also be evaluated during and after tooth whitening using the VAS pain scale. There will be 3 whitening sessions with a 7-day interval between them. The alteration of color and presence of sensitivity will also be evaluated at the times of 14 days and 2 months after the whitening ends. A gel containing 35% hydrogen peroxide will be used. The final color evaluator and responsible for interviewing the patient about the sensitivity will be blind as to which treatment was applied on each side of the patient's arcade."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Good oral hygiene conditions\n* Good general health conditions and without systemic disease\n* Presence of all teeth, without caries, periodontal disease, restorations, endodontic treatment, crowns\n* Patients with dental color A3 or darker, according to the VITA \\* Classical Color Scale.\n\nExclusion Criteria:\n\n* Pregnant and lactating female patients\n* Presence of caries, periodontal disease or any other infectious source in the oral cavity\n* Systematic use of tobacco and alcoholic beverages\n* Chronic use of corticosteroids, as well as who makes use of analgesics or anti-inflammatories before or during 48 hours after dental bleaching\n* Patients with dentin hypersensitivity\n* Patients with tooth color alteration by tetracycline, fluorosis, endodontic treatment.\n* Volunteers who use removable prostheses'}, 'identificationModule': {'nctId': 'NCT04013659', 'briefTitle': 'Effect of Gel Renewal During In-office Dental Bleaching', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Ibirapuera'}, 'officialTitle': 'Effect of Gel Renewal During In-office Dental Bleaching Using Violet LED Light as Photo-accelerator. A Randomized Blind Clinical Trial', 'orgStudyIdInfo': {'id': '90670218.3.0000.5597'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'G1 - Permanence of the Whitening Gel', 'description': 'Permanence of the Whitening Gel (Biological Product: 35% Hydrogen Peroxide) on the tooth enamel during the 15 minutes of dental-bleaching', 'interventionNames': ['Other: Dental Bleaching with 35% hydrogen peroxide gel + Violet LED Irradiation']}, {'type': 'EXPERIMENTAL', 'label': 'G2 - Renewal of the Whitening Gel', 'description': '3 Whitening Gel (Biological Product: 35% Hydrogen Peroxide) renewal every 5 minutes during the 15 minutes of dental-bleaching', 'interventionNames': ['Other: Dental Bleaching with 35% hydrogen peroxide gel + Violet LED Irradiation']}], 'interventions': [{'name': 'Dental Bleaching with 35% hydrogen peroxide gel + Violet LED Irradiation', 'type': 'OTHER', 'description': 'After gum protection, the bleaching gel (35% hydrogen peroxide) was applied to the surface of the tooth and irradiated with VIOLET LED', 'armGroupLabels': ['G1 - Permanence of the Whitening Gel', 'G2 - Renewal of the Whitening Gel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04661-100', 'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Karen M Ramalho, PhD', 'role': 'CONTACT', 'email': 'karenramalho@hotmail.com', 'phone': '+55 11 989385397'}], 'facility': 'Universidade Ibirapuera', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Karen M Ramalho, PhD', 'role': 'CONTACT', 'email': 'karenramalho@hotmail.com', 'phone': '11989385397', 'phoneExt': '+5511'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Ibirapuera', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor', 'investigatorFullName': 'Karen Müller Ramalho', 'investigatorAffiliation': 'Universidade Ibirapuera'}}}}