Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 10:41 PM
Study NCT ID:
NCT03760367
Status:
COMPLETED
Last Update Posted:
2019-11-19
First Post:
2018-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigation of the Instant Tooth Whitening Effect of a Silica Toothpaste Containing Blue Covarine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants are randomly assigned to one of the two arms and perform the treatment without knowing whether they use the blue covarine toothpaste or the control toothpaste. Treatment outcomes are assessed by a) a blinded operator and b) the blinded participants in a different room. Allocation of treatment groups will be revealed to the principal investigator after all data have been collected.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are assigned to one of two groups - blue covarine toothpaste and control toothpaste group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-11-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-15', 'studyFirstSubmitDate': '2018-11-19', 'studyFirstSubmitQcDate': '2018-11-29', 'lastUpdatePostDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '3D VITA SYSTEM 3D-MASTER tooth color change', 'timeFrame': 'Tooth color is measured twice, right before (baseline) and immediately after toothbrushing.', 'description': 'Tooth color change of the upper right first incisor is assessed after toothbrushing compared to baseline using a spectrophotometer.'}, {'measure': 'Change of participant satisfaction with the tooth color', 'timeFrame': 'Participant satisfaction is assessed twice, right before (baseline) and immediately after toothbrushing.', 'description': 'Change of participant satisfaction with the color of their upper front teeth is assessed after toothbrushing compared to baseline using an 11 step aesthetic numeric analogue scale (ANA scale, Funk et al., 2011; DOI: https://doi.org/10.1016/j.jcms.2011.07.018).'}], 'secondaryOutcomes': [{'measure': 'Change of blue-yellow color component of the tooth (b* in the CIELAB color space)', 'timeFrame': 'The blue-yellow color component is assessed twice, right before (baseline) and immediately after toothbrushing.', 'description': 'The change of the blue-yellow color component of the upper right first incisor is assessed after toothbrushing compared to baseline using a spectrophotometer.'}, {'measure': 'Change of the green-red color component of the tooth (a* in the CIELAB color space)', 'timeFrame': 'The green-red color component is assessed twice, right before (baseline) and immediately after toothbrushing.', 'description': 'The change of the green-red color component of the upper right first incisor is assessed after toothbrushing compared to baseline using a spectrophotometer.'}, {'measure': 'Change of the tooth lightness value (L* in the CIELAB color space)', 'timeFrame': 'The tooth lightness is assessed twice, right before (baseline) and immediately after toothbrushing.', 'description': 'The change of lightness of the upper right first incisor is assessed after toothbrushing compared to baseline using a spectrophotometer.'}, {'measure': 'Participant evaluation of tooth color change', 'timeFrame': 'The color change of the upper front teeth is assessed once: immediately after toothbrushing.', 'description': 'The color change of their upper front teeth is assessed visually by the participants using an 11 step aesthetic numeric analogue scale (ANA scale, Funk et al., 2011; DOI: https://doi.org/10.1016/j.jcms.2011.07.018).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['blue covarine', 'numeric analogue scale', 'spectrophotometry', 'tooth bleaching'], 'conditions': ['Tooth Whitening']}, 'descriptionModule': {'briefSummary': 'The study investigates the effect of toothbrushing with a toothpaste containing blue covarine compared to a control toothpaste without blue covarine on tooth color. Participants brush their teeth once with either the blue covarine containing toothpaste or a control toothpaste for two minutes. Before and after brushing, tooth color is assessed with a spectrophotometer. Moreover, satisfaction of the participants with their tooth color is assessed using a numeric analogue scale before and after treatment.\n\nThe null hypotheses are that neither brushing with the toothpaste containing blue covarine nor brushing with the control toothpaste change a) the tooth color and b) the satisfaction of the participants with their tooth color.', 'detailedDescription': 'Participants are recruited by advertizing in several public areas in Aarhus, Denmark.\n\nWritten and oral information on the study is provided, eligibility criteria are checked, and informed consent is given by the participants.\n\nThe upper front teeth of the participants are cleaned with pumice and a rubber cup by operator A.\n\nParticipants look at the color of their upper front teeth with a mirror, in a room with controlled lighting conditions.\n\nThereafter, participants rate their satisfaction with the color of their teeth using an 11-point aesthetic numeric analogue scale.\n\nTooth color is assessed by operator B using a spectrophotometer (VITA Easyshade Advance) and a positioning device to standardize measurements. Measurements are performed in a room with controlled lighting conditions. VITA SYSTEM 3D-MASTER color, L\\*, a\\* and b\\* are recorded.\n\nParticipants are then randomly assigned to either the blue covarine toothpaste group or the control toothpaste group.\n\nThey are given a short video introduction to the Bass toothbrushing technique by operator C (caregiver).\n\nOperator C provides a toothbrush and 1 g of either blue covarine toothpaste or control toothpaste, according to the randomization scheme.\n\nParticipants brush their teeth for two min, starting with the upper front teeth, and then rinse their mouth with tap water.\n\nThereafter, participants look again at the color of their upper front teeth with a mirror, in the same room as before treatment.\n\nThey rate their satisfaction with the color of their teeth using the 11-point aesthetic numeric analogue scale.\n\nMoreover, they rate the color difference before and after treatment on an 11-point aesthetic numeric analogue scale.\n\nAgain, tooth color is assessed by operator B using a spectrophotometer (VITA Easyshade Advance) and a positioning device to standardize measurements. Measurements are performed in the room with controlled lighting conditions. Again VITA SYSTEM 3D-MASTER color, L\\*, a\\* and b\\* are recorded.\n\nThe null hypotheses of the study are that neither brushing with the toothpaste containing blue covarine nor brushing with the control toothpaste change a) the tooth color and b) the satisfaction of the participants with their tooth color.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers\n\nExclusion Criteria:\n\n* Dental caries in the upper front teeth\n* Intrinsic stain of the upper front teeth, including tetracyclin stains, fluorosis, and staining due to pulpitis or pulp necrosis\n* Dental restorations in the upper front teeth, including fillings, veneers, crowns, and root canal fillings\n* Dental anomalies of the upper front teeth, including molar incisor hypomineralisation, amelogenesis imperfecta, and dentinogenesis imperfecta'}, 'identificationModule': {'nctId': 'NCT03760367', 'briefTitle': 'Investigation of the Instant Tooth Whitening Effect of a Silica Toothpaste Containing Blue Covarine', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Investigation of the Instant Tooth Whitening Effect of a Silica Toothpaste Containing Blue Covarine - a Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'IOOS_TA_01_2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Blue Covarine Toothpaste', 'description': 'After a short video introduction to the bass technique, participants brush their teeth once with a silica toothpaste containing blue covarine (Pepsodent White Now Gold, 1 g) for 2 min, starting with the upper front teeth. Thereafter, participants rinse their mouth with of tap water.', 'interventionNames': ['Other: Blue covarine toothpaste']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Toothpaste', 'description': 'After a short video introduction to the bass technique, participants brush their teeth once with a silica toothpaste (Colgate Advanced Whitening, 1 g) for 2 min, starting with the upper front teeth. Thereafter, participants rinse their mouth with of tap water.', 'interventionNames': ['Other: Control toothpaste']}], 'interventions': [{'name': 'Blue covarine toothpaste', 'type': 'OTHER', 'otherNames': ['Pepsodent White Now Gold'], 'description': '2 min toothbrushing with 1 g of Pepsodent White Now Gold', 'armGroupLabels': ['Blue Covarine Toothpaste']}, {'name': 'Control toothpaste', 'type': 'OTHER', 'otherNames': ['Colgate Advanced Whitening'], 'description': '2 min toothbrushing with 1 g of Colgate Advanced Whitening', 'armGroupLabels': ['Control Toothpaste']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus University, Department of Dentistry and Oral Health', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Sebastian Schlafer, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University, Department of Dentistry and Oral Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Due to general data protection regulations, individual participant data will not be made available publicly. Summary data will be made available upon publication of the results.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}