Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-26 @ 4:09 AM
Study NCT ID:
NCT03933527
Status:
COMPLETED
Last Update Posted:
2019-05-01
First Post:
2019-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Staining Beverage on Color Alteration During In-office Tooth Bleaching
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014075', 'term': 'Tooth Discoloration'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'factorial assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-04-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-27', 'studyFirstSubmitDate': '2019-04-27', 'studyFirstSubmitQcDate': '2019-04-27', 'lastUpdatePostDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in tooth colour', 'timeFrame': '4 weeks', 'description': 'Colour parameters (CIE L\\*, a\\*, b\\*) will be measured with a spectrophotometer (Vita Easyshade Advance 4.0). The color alteration after each session will be given by the differences between the values obtained at the sessions and the baseline (∆E).'}], 'secondaryOutcomes': [{'measure': 'Change in tooth whiteness', 'timeFrame': '4 weeks', 'description': 'The whiteness index will be registered at the sessions and the baseline.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tooth bleaching', 'staining beverage'], 'conditions': ['Tooth Discoloration']}, 'referencesModule': {'references': [{'pmid': '32169479', 'type': 'DERIVED', 'citation': 'Chen YH, Yang S, Hong DW, Attin T, Yu H. Short-term effects of stain-causing beverages on tooth bleaching: A randomized controlled clinical trial. J Dent. 2020 Apr;95:103318. doi: 10.1016/j.jdent.2020.103318. Epub 2020 Mar 10.'}]}, 'descriptionModule': {'briefSummary': 'This double-blind randomized controlled clinical trial aimed to investigate the effect of staining beverage on color alteration of in-office tooth bleaching procedures.', 'detailedDescription': "Sixty-three eligible participants (25 males and 38 females, mean age 26.5 years) with at least one maxillary tooth demonstrating shade A3 or darker will be recruited and randomly allocated into 3 groups (n = 21), according to the different staining beverage used in this clinical trial: Coffee for group C, Tea for group T, and distilled water for group W. All participants will receive in-office tooth bleaching with 40% hydrogen peroxide (Opalescence Boost PF 40%) for the maxillary anterior teeth (2 sessions, with a 1-week interval). The participants will be instructed to use only the provided beverage rinses for 30 seconds, four times daily. Colour parameters (CIE L\\*, a\\*, b\\*) will be measured with a spectrophotometer (Vita Easyshade Advance 4.0) at baseline (T1), after the first bleaching session (T2), after the second bleaching session (T3), 1 week after the completion of in-office bleaching (T4), and 3 weeks after the completion of in-office bleaching (T5). The colour differences (ΔE) and whiteness index (W) will also be calculated. The data will be statistically analysed through repeated ANOVA and Tukey's test (α = 0.05)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients between 18 and 30 years of age, with fully erupted upper and lower incisors and canines without dental or periodontal disease or restorations, and with at least one maxillary tooth presenting color score A3 or darker, as measured with the Vita Classical guide (Vita Zahnfabrik, Bad Sa ̈ ckingen, Germany) ordered by brightness\n\nExclusion Criteria:\n\n* patients with systemic diseases or oral mucosal disorders, previous bleaching treatment, patients undergoing orthodontic treatment, pregnant women, people with known allergy to the product ingredients, smokers, and alcohol abusers.'}, 'identificationModule': {'nctId': 'NCT03933527', 'briefTitle': 'The Effect of Staining Beverage on Color Alteration During In-office Tooth Bleaching', 'organization': {'class': 'OTHER', 'fullName': 'Fujian Medical University'}, 'officialTitle': 'The Effect of Staining Beverage on Color Alteration During In-office Tooth Bleaching: A Randomized Controlled Clinical Trial.', 'orgStudyIdInfo': {'id': '20190214'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'Participants will receive in-office tooth bleaching with 40% hydrogen peroxide (Opalescence Boost PF 40%) for the maxillary anterior teeth (2 sessions, with a 1-week interval).'}, {'type': 'EXPERIMENTAL', 'label': 'coffee group', 'description': 'Participants will receive in-office tooth bleaching with 40% hydrogen peroxide (Opalescence Boost PF 40%) for the maxillary anterior teeth (2 sessions, with a 1-week interval).During the tooth bleaching procedure and 3 weeks after the procedure,the participants will be instructed to make coffee rinses for 30 seconds, four times daily.', 'interventionNames': ['Behavioral: making staining beverage rinse during in-office tooth bleaching']}, {'type': 'EXPERIMENTAL', 'label': 'tea group', 'description': 'Participants will receive in-office tooth bleaching with 40% hydrogen peroxide (Opalescence Boost PF 40%) for the maxillary anterior teeth (2 sessions, with a 1-week interval).During the tooth bleaching procedure and 3 weeks after the procedure,the participants will be instructed to make tea rinses for 30 seconds, four times daily.', 'interventionNames': ['Behavioral: making staining beverage rinse during in-office tooth bleaching']}], 'interventions': [{'name': 'making staining beverage rinse during in-office tooth bleaching', 'type': 'BEHAVIORAL', 'description': 'the subjects in experimental group should make staining beverage(coffee or tea) rinse for 30 second, four times daily.', 'armGroupLabels': ['coffee group', 'tea group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '350004', 'city': 'Fuzhou', 'state': 'Fujian', 'country': 'China', 'facility': 'Fujian Medical University', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}], 'overallOfficials': [{'name': 'Hao Yu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fujian Medical University, China'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fujian Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Fujian Medical University', 'investigatorFullName': 'Hao Yu', 'investigatorAffiliation': 'Fujian Medical University'}}}}